Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT01931956
Status:
COMPLETED
Last Update Posted:
2018-12-04
First Post:
2013-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Real World Expanded Multicenter Study of the MitraClip® System (REALISM)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}, {'id': 'D008945', 'term': 'Mitral Valve Prolapse'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016127', 'term': 'Heart Valve Prolapse'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jeffrey.ellis@av.abbott.com', 'title': 'Jeffrey T Ellis', 'organization': 'Abbott Vascular'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '5 years', 'eventGroups': [{'id': 'EG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.\n\nMitraClip® implant: Percutaneous mitral valve repair using MitraClip implant', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 39, 'seriousNumAtRisk': 59, 'deathsNumAffected': 42, 'seriousNumAffected': 49}, {'id': 'EG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 4, 'seriousNumAtRisk': 7, 'deathsNumAffected': 7, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.', 'otherNumAtRisk': 628, 'deathsNumAtRisk': 628, 'otherNumAffected': 503, 'seriousNumAtRisk': 628, 'deathsNumAffected': 379, 'seriousNumAffected': 542}, {'id': 'EG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.', 'otherNumAtRisk': 271, 'deathsNumAtRisk': 271, 'otherNumAffected': 225, 'seriousNumAtRisk': 271, 'deathsNumAffected': 96, 'seriousNumAffected': 208}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 69}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 32}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Infection/Bacteremia/Septicemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Atrial Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 60}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 34}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Atrial Septal Defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Bradyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Chest Pain/Angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 37}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Congestive Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 64}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 24}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Lead Displacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Left Ventricular Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Mitral Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Mitral Valve Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 43}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 20}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Other Rhythm Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pericardial Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 16}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Peripheral Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 18}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Residual/Recurrent MR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 103}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 55}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'SLDA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Syncope/Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 18}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ventricular Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 85}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 44}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Generalized Weakness/Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 51}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Mental Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Metabolic/Endocrine Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 70}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 141}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 62}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Connective Tissue Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 91}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 55}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 53}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 53}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 18}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 58}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 22}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Renal Insufficiency/Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 66}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 26}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bronchial/Lung Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 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{'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Transient Ischemic Attack (TIA)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'MV Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'SLDA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Heart transplant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Left ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Mitral valve injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Myocardial ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'peripheral edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Supraventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bradyarrythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Emergent MV surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hematologic-Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Mesentric Ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Heart Block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 628, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 271, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Major Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '628', 'groupId': 'OG002'}, {'value': '271', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high RIsk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'A combined clinical endpoint of death, myocardial infarction (MI), re-operation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, gastro-intestinal (GI) complication requiring surgery, new onset of permanent atrial fibrillation, septicemia and transfusion of 2 or more units of blood.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-To-Treat Population set (ITT)'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Major Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '628', 'groupId': 'OG002'}, {'value': '271', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'A combined clinical endpoint of death, myocardial infarction (MI), re-operation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia and transfusion of 2 or more units of blood.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'PRIMARY', 'title': 'Number of Participants With 12-Month Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '556', 'groupId': 'OG002'}, {'value': '248', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '339', 'groupId': 'OG002'}, {'value': '166', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Defined as freedom from: Surgery for Mitral Regurgitation (MR) or Valve Dysfunction, death, and MR \\> 2+ (moderate to severe (3+) or severe MR (4+)).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed in 52 participants out of 59 in CU arm, in 6 subjects out of 7 in EU arm, in 556 participants out of 628 participants and 248 out of 271 participants in non-HR arm were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '628', 'groupId': 'OG002'}, {'value': '271', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '204', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'The definition of a serious adverse event is an event that is fatal or life threatening, results in persistent or significant disability, requires intervention to prevent permanent impairment/damage, or an event that results in congenital anomaly, malignancy, hospital admission or prolongation of hospitalization.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '628', 'groupId': 'OG002'}, {'value': '271', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '388', 'groupId': 'OG002'}, {'value': '131', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'The definition of a serious adverse event is an event that is fatal or life threatening, results in persistent or significant disability, requires intervention to prevent permanent impairment/damage, or an event that results in congenital anomaly, malignancy, hospital admission or prolongation of hospitalization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Atrial Septal Defect (ASD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '628', 'groupId': 'OG002'}, {'value': '271', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Atrial Septal Defect (ASD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '628', 'groupId': 'OG002'}, {'value': '271', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors.The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM.\n\nThe patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implants.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Major Adverse Events (MAE) in Patients Over 75 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '393', 'groupId': 'OG002'}, {'value': '140', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'CU Arm:\n\nThere are 27 patients \\>75 years old in the CU arm. Safety data are available only for 26 patients.\n\nEU Arm:\n\nThere are 5 patients \\>75 years old in the EU arm.\n\nHR arm:\n\nThere are 393 patients \\>75 years old in the HR arm.\n\nNon-HR arm:\n\nThere are 140 patients \\>75 years old in the Non-HR arm.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Major Adverse Events in Patients Over 75 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '393', 'groupId': 'OG002'}, {'value': '140', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Months', 'description': 'MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'CU Arm:\n\nThere are 27 patients \\>75 years old in the CU arm. Safety data are available only for 26 patients.\n\nEU Arm:\n\nThere are 5 patients \\>75 years old in the EU arm.\n\nHR arm:\n\nThere are 393 patients \\>75 years old in the HR arm.\n\nNon-HR arm:\n\nThere are 140 patients \\>75 years old in the Non-HR arm.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Major Adverse Events in Patients Over 75 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '393', 'groupId': 'OG002'}, {'value': '140', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'CU Arm:\n\nThere are 27 patients \\>75 years old in the CU arm. Safety data are available only for 26 patients.\n\nEU Arm:\n\nThere are 5 patients \\>75 years old in the EU arm.\n\nHR arm:\n\nThere are 393 patients \\>75 years old in the HR arm.\n\nNon-HR arm:\n\nThere are 140 patients \\>75 years old in the Non-HR arm.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Major Adverse Events in Patients Over 75 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '393', 'groupId': 'OG002'}, {'value': '140', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 years', 'description': 'MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'CU Arm:\n\nThere are 27 patients \\>75 years old in the CU arm. Safety data are available only for 26 patients.\n\nEU Arm:\n\nThere are 5 patients \\>75 years old in the EU arm.\n\nHR arm:\n\nThere are 393 patients \\>75 years old in the HR arm.\n\nNon-HR arm:\n\nThere are 140 patients \\>75 years old in the Non-HR arm.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Major Adverse Events in Patients Over 75 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '393', 'groupId': 'OG002'}, {'value': '140', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 years', 'description': 'MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'CU Arm:\n\nThere are 27 patients \\>75 years old in the CU arm. Safety data are available only for 24 patients.\n\nEU Arm:\n\nThere are 5 patients \\>75 years old in the EU arm.\n\nHR arm:\n\nThere are 393 patients \\>75 years old in the HR arm.\n\nNon-HR arm:\n\nThere are 140 patients \\>75 years old in the Non-HR arm.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Major Adverse Events in Patients Over 75 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '393', 'groupId': 'OG002'}, {'value': '140', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'CU Arm:\n\nThere are 27 patients \\>75 years old in the CU arm. Safety data are available only for 24 patients.\n\nEU Arm:\n\nThere are 5 patients \\>75 years old in the EU arm.\n\nHR arm:\n\nThere are 393 patients \\>75 years old in the HR arm.\n\nNon-HR arm:\n\nThere are 140 patients \\>75 years old in the Non-HR arm.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Acute Procedural Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '628', 'groupId': 'OG002'}, {'value': '271', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '524', 'groupId': 'OG002'}, {'value': '229', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At discharge (an average of ≤ 12.3 days post-index procedure)', 'description': 'Defined as successful implantation of the Clip(s) with resulting MR severity of 2+ or less as determined by the echocardiographic assessment at discharge. The 30-day echocardiogram will be used if the discharge echocardiogram is unavailable or uninterpretable, providing the patient has not undergone subsequent surgery after attempted clip.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Procedural Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '628', 'groupId': 'OG002'}, {'value': '271', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '541', 'groupId': 'OG002'}, {'value': '239', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Defined as successful implantation of the Clip(s) with resulting MR severity of 2+ of less at discharge or a 1 grade MR reduction at discharge accompanied by a 1 level reduction in NYHA at 30 days.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Durability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '628', 'groupId': 'OG002'}, {'value': '271', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '325', 'groupId': 'OG002'}, {'value': '163', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Defined as the proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that at 12 months have not required surgery for valve dysfunction and meet either of the following: 1) MR severity grade of 2+ or less or 2) a one grade reduction in MR severity compared to baseline accompanied by at least a one level reduction in NYHA at 12 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clip Implant Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '628', 'groupId': 'OG002'}, {'value': '271', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the nonhigh risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '603', 'groupId': 'OG002'}, {'value': '258', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'On the day of index procedure (≤1 day)', 'description': 'Defined as the procedural rate of successful delivery and deployment of Clip implants with echocardiographic evidence of leaflet approximation and retrieval of the investigational delivery catheter.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Procedure Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '619', 'groupId': 'OG002'}, {'value': '262', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '141.7', 'spread': '70.4', 'groupId': 'OG000'}, {'value': '123.6', 'spread': '55.9', 'groupId': 'OG001'}, {'value': '139.0', 'spread': '66.8', 'groupId': 'OG002'}, {'value': '137.8', 'spread': '68.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'On the day of index procedure', 'description': 'The mean procedure time is defined as the start time of the transseptal procedure to the time the steerable guide catheter (SGC) is removed.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Device Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '616', 'groupId': 'OG002'}, {'value': '262', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors.The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '115.1', 'spread': '65.6', 'groupId': 'OG000'}, {'value': '96.6', 'spread': '60.2', 'groupId': 'OG001'}, {'value': '106.8', 'spread': '58.2', 'groupId': 'OG002'}, {'value': '111.5', 'spread': '63.8', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'On the day of index procedure', 'description': 'Device time is defined as the time of insertion of the Steerable Guide Catheter (SGC) to the time the MitraClip delivery catheter is retracted into the SGC.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Fluoroscopy Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '627', 'groupId': 'OG002'}, {'value': '269', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors.The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.5', 'spread': '28.9', 'groupId': 'OG000'}, {'value': '33.6', 'spread': '21.3', 'groupId': 'OG001'}, {'value': '38.5', 'spread': '24.4', 'groupId': 'OG002'}, {'value': '34.6', 'spread': '20.0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'On the day of index procedure', 'description': 'Mean fluoroscopy duration during the MitraClip procedure.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With MitraClip Devices Implanted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '628', 'groupId': 'OG002'}, {'value': '271', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors.The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'title': '0 Clips', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': '1 Clip', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '333', 'groupId': 'OG002'}, {'value': '160', 'groupId': 'OG003'}]}]}, {'title': '2 Clips', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '268', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}]}, {'title': '3 Clips', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'On the day of index procedure', 'description': 'The distribution of number of MitraClip devices implanted in patients.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Post-Procedure Intensive Care Unit (ICU)/ Critical Care Unit (CCU)/ Post-anesthesia Care Unit (PACU) Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '628', 'groupId': 'OG002'}, {'value': '270', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors.The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.1', 'spread': '29.9', 'groupId': 'OG000'}, {'value': '149.3', 'spread': '179.3', 'groupId': 'OG001'}, {'value': '36.5', 'spread': '70.3', 'groupId': 'OG002'}, {'value': '28.8', 'spread': '69.5', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At discharge (an average of ≤ 12.3 days post-index procedure).', 'description': 'Defined as the number of hours for which patients are in an intensive care unit or step down unit before discharge or moving to a standard care unit.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Post-Procedure Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '627', 'groupId': 'OG002'}, {'value': '270', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors.The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '12.3', 'spread': '7.5', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '4.6', 'groupId': 'OG002'}, {'value': '2.8', 'spread': '4.8', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At discharge (an average of ≤ 12.3 days post-index procedure).', 'description': 'Defined as the number of days from the end of the procedure until the patient is discharged from the hospital. This does not include time in a nursing or skilled care facility.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors.The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'title': 'Cardiac', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'Non-Cardiac', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': 'Not Adjudicated', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Not Adjudicable', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months visit window (410 days)', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)\n\nNon-cardiac death is defined as a death not due to cardiac causes (as defined above).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '628', 'groupId': 'OG002'}, {'value': '271', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors.The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'title': 'Home', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '523', 'groupId': 'OG002'}, {'value': '248', 'groupId': 'OG003'}]}]}, {'title': 'Home with home health care', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'Nursing home', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Skilled nursing facility', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Long-term acute care', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Withdrawal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At discharge (an average of ≤ 12.3 days post-index procedure)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Hospital Re-admissions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '628', 'groupId': 'OG002'}, {'value': '271', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Defined as re-admission of patients to the hospital following discharge from the Clip procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Device Embolization or Single Leaflet Device Attachment (SLDA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '628', 'groupId': 'OG002'}, {'value': '271', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors.The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 5 years', 'description': 'A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Mitral Stenosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '603', 'groupId': 'OG002'}, {'value': '258', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 5 years', 'description': 'Mitral stenosis is a key safety consideration assessed after implantation of the MitraClip device. It is defined as Mitral Valve Area (MVA) less than 1.5 cm\\^2 as assessed by the Echocardiography Core Laboratory (ECL).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Mitral Regurgitation (MR) Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '587', 'groupId': 'OG002'}, {'value': '264', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'title': '0+: None', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': '1+: Mild', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '315', 'groupId': 'OG002'}, {'value': '144', 'groupId': 'OG003'}]}, {'title': '2+: Moderate', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}, {'title': '3+: Moderate to Severe', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}, {'title': '4+: Severe', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days(Follow-up)', 'description': 'Paired site-assessed Mitral regurgitation severity between baseline and 30 days using echocardiography.\n\nMR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With MR Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '410', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'title': '0+: None', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'title': '1+: Mild', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}, {'title': '2+: Moderate', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '173', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}, {'title': '3+: Moderate to Severe', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}, {'title': '4+: Severe', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Paired site-assessed Mitral regurgitation severity between baseline and 12 months using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With MR Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'title': '0+: None', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'title': '1+: Mild', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}, {'title': '2+: Moderate', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}]}, {'title': '3+: Moderate to Severe', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}, {'title': '4+: Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'Paired site-assessed Mitral regurgitation severity between baseline and 2 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With MR Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '222', 'groupId': 'OG002'}, {'value': '159', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'title': '0+: None', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}, {'title': '1+: Mild', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}, {'title': '2+: Moderate', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}, {'title': '3+: Moderate to Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}, {'title': '4+: Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 years', 'description': 'Paired site-assessed Mitral regurgitation severity between baseline and 3 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With MR Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'title': '0+: None', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'title': '1+: Mild', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}, {'title': '2+: Moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}, {'title': '3+: Moderate to Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}, {'title': '4+: Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 years', 'description': 'Paired site-assessed Mitral regurgitation severity between baseline and 4 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The 4-year visit was optional and no data were collected at this time point for CU and EU arm.\n\nThe number of participants analyzed includes subjects who had available follow up data at that time frame in HR and Non-HR arm.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With MR Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'title': '0+:None', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'title': '1+:Mild', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}, {'title': '2+:Moderate', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}, {'title': '3+:Moderate to Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}, {'title': '4+:Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'Paired site-assessed Mitral regurgitation severity between baseline and 5 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Second Intervention to Place an Additional Mitraclip Device.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '628', 'groupId': 'OG002'}, {'value': '271', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '139 days post the index procedure', 'description': 'If residual MR was determined to be clinically unacceptable for patients who received only 1 clip during the index procedure, a second intervention to place an additional MitraClip device could be considered.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Second Intervention to Place an Additional Mitraclip Device.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '628', 'groupId': 'OG002'}, {'value': '271', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'If residual MR was determined to be clinically unacceptable for patients who received only 1 clip during the index procedure, a second intervention to place an additional MitraClip device could be considered.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With New York Heart Association (NYHA) Functional Class', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '560', 'groupId': 'OG002'}, {'value': '252', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'title': 'NYHA Functional Class I', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}, {'value': '113', 'groupId': 'OG003'}]}, {'title': 'NYHA Functional Class II', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '296', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}, {'title': 'NYHA Functional Class III', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}, {'title': 'NYHA Functional Class IV', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Paired NYHA data from baseline to 30 days. Class I: Patients with cardiac disease but without resulting limitations of physical activity.\n\nClass II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.\n\nClass III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.\n\nClass IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With NYHA Functional Class', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '403', 'groupId': 'OG002'}, {'value': '204', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'title': 'NYHA Functional Class I', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}, {'value': '121', 'groupId': 'OG003'}]}, {'title': 'NYHA Functional Class II', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}, {'title': 'NYHA Functional Class III', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}, {'title': 'NYHA Functional Class IV', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Paired NYHA data from baseline to 12 months. Class I: Patients with cardiac disease but without resulting limitations of physical activity.\n\nClass II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.\n\nClass III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.\n\nClass IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With NYHA Functional Class', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '293', 'groupId': 'OG002'}, {'value': '182', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'title': 'NYHA Functional Class I', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}, {'value': '99', 'groupId': 'OG003'}]}, {'title': 'NYHA Functional Class II', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}, {'title': 'NYHA Functional Class III', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}, {'title': 'NYHA Functional Class IV', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'Paired NYHA data from baseline to 2 years. Class I: Patients with cardiac disease but without resulting limitations of physical activity.\n\nClass II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.\n\nClass III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.\n\nClass IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With NYHA Functional Class', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '224', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'title': 'NYHA Functional Class I', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}]}, {'title': 'NYHA Functional Class II', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}, {'title': 'NYHA Functional Class III', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}, {'title': 'NYHA Functional Class IV', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 years', 'description': 'Paired NYHA data from baseline to 3 years. Class I: Patients with cardiac disease but without resulting limitations of physical activity.\n\nClass II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.\n\nClass III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.\n\nClass IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With NYHA Functional Class', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}, {'value': '125', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'title': 'NYHA Functional Class I', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}]}, {'title': 'NYHA Functional Class II', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}, {'title': 'NYHA Functional Class III', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}, {'title': 'NYHA Functional Class IV', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 years', 'description': 'Paired NYHA data from baseline to 4 years. Class I: Patients with cardiac disease but without resulting limitations of physical activity.\n\nClass II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.\n\nClass III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.\n\nClass IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The 4-year visit was optional and no data were collected at this time point for CU and EU arm.\n\nThe number of participants analyzed includes subjects who had available follow up data at that time frame in HR and Non-HR arm.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With NYHA Functional Class', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}, {'value': '119', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'title': 'NYHA Functional Class I', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}, {'title': 'NYHA Functional Class II', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}, {'title': 'NYHA Functional Class III', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}, {'title': 'NYHA Functional Class IV', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'Paired NYHA data from baseline to 5 years. Class I: Patients with cardiac disease but without resulting limitations of physical activity.\n\nClass II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.\n\nClass III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.\n\nClass IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular End-diastolic Volume (LVEDV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '514', 'groupId': 'OG002'}, {'value': '231', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '163.9', 'spread': '68.2', 'groupId': 'OG000'}, {'value': '110.7', 'spread': '25.1', 'groupId': 'OG001'}, {'value': '143.1', 'spread': '54.1', 'groupId': 'OG002'}, {'value': '121.8', 'spread': '43.8', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days', 'description': 'Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to discharge or 30 days as determined by echo core laboratory.', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular End-diastolic Volume (LVEDV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '335', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '171.1', 'spread': '83.4', 'groupId': 'OG000'}, {'value': '142.9', 'spread': '57.3', 'groupId': 'OG002'}, {'value': '120.9', 'spread': '30.0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 12 months as determined by echo core laboratory.', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular End-diastolic Volume (LVEDV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}, {'value': '153', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '175.0', 'spread': '65.4', 'groupId': 'OG000'}, {'value': '148.2', 'spread': '68.2', 'groupId': 'OG002'}, {'value': '119.6', 'spread': '40.0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 24 months as determined by echo core laboratory.', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular End-diastolic Volume (LVEDV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}, {'value': '141', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '155.7', 'spread': '56.9', 'groupId': 'OG000'}, {'value': '150.9', 'spread': '69.0', 'groupId': 'OG002'}, {'value': '120.1', 'spread': '41.0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36 months', 'description': 'Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 36 months as determined by echo core laboratory.', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular End-diastolic Volume (LVEDV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '138.6', 'spread': '68.2', 'groupId': 'OG002'}, {'value': '128.1', 'spread': '38.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 months', 'description': 'Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 48 months as determined by the echo core laboratory.', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular End-diastolic Volume (LVEDV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '146.1', 'spread': '71.4', 'groupId': 'OG002'}, {'value': '125.9', 'spread': '45.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 months', 'description': 'Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 60 months as determined by echo core laboratory.', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular End-systolic Volume (LVESV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '513', 'groupId': 'OG002'}, {'value': '231', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.7', 'spread': '58.9', 'groupId': 'OG000'}, {'value': '46.3', 'spread': '21.5', 'groupId': 'OG001'}, {'value': '82.9', 'spread': '44.7', 'groupId': 'OG002'}, {'value': '59.4', 'spread': '31.9', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days', 'description': 'Paired Left ventricular end-systolic volume (LVESV) data from baseline to discharge or 30 days as determined by echo core laboratory.', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular End-systolic Volume (LVESV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '354', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '102.2', 'spread': '71.8', 'groupId': 'OG000'}, {'value': '80.4', 'spread': '48.6', 'groupId': 'OG002'}, {'value': '57.6', 'spread': '29.5', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Paired Left ventricular end-systolic volume (LVESV) data from baseline to 12 months as determined by echo core laboratory.', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular End-systolic Volume (LVESV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '189', 'groupId': 'OG002'}, {'value': '153', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.7', 'spread': '56.0', 'groupId': 'OG000'}, {'value': '85.9', 'spread': '59.0', 'groupId': 'OG002'}, {'value': '57.1', 'spread': '32.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'Paired Left ventricular end-systolic volume (LVESV) data from baseline to 24 months as determined by echo core laboratory.', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular End-systolic Volume (LVESV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}, {'value': '141', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '97.0', 'spread': '52.5', 'groupId': 'OG000'}, {'value': '88.8', 'spread': '60.2', 'groupId': 'OG002'}, {'value': '55.8', 'spread': '32.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36 months', 'description': 'Paired Left ventricular end-systolic volume (LVESV) data from baseline to 36 months as determined by echo core laboratory.', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular End-systolic Volume (LVESV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '77.8', 'spread': '61.6', 'groupId': 'OG002'}, {'value': '55.3', 'spread': '26.5', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 months', 'description': 'Paired Left ventricular end-systolic volume (LVESV) data from baseline to 48 months as determined by echo core laboratory.', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular End-systolic Volume (LVESV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '85.4', 'spread': '62.9', 'groupId': 'OG002'}, {'value': '59.0', 'spread': '38.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 months', 'description': 'Paired Left ventricular end-systolic volume (LVESV) data from baseline to 60 months as determined by echo core laboratory.', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Internal Dimension Diastole (LVIDd)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '565', 'groupId': 'OG002'}, {'value': '257', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '5.4', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '5.1', 'spread': '0.7', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days', 'description': 'Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to discharge or 30 days as determined by echo core laboratory.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Internal Dimension Diastole (LVIDd)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '396', 'groupId': 'OG002'}, {'value': '201', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '0.9', 'groupId': 'OG002'}, {'value': '5.1', 'spread': '0.7', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 12 months as determined by echo core laboratory.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Internal Dimension Diastole (LVIDd)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '213', 'groupId': 'OG002'}, {'value': '169', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '1.0', 'groupId': 'OG002'}, {'value': '5.0', 'spread': '0.7', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 24 months as determined by echo core laboratory.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Internal Dimension Diastole (LVIDd)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}, {'value': '156', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '1.0', 'groupId': 'OG002'}, {'value': '5.2', 'spread': '0.8', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36 months', 'description': 'Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 36 months as determined by echo core laboratory.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Internal Dimension Diastole (LVIDd)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'spread': '1.0', 'groupId': 'OG002'}, {'value': '5.2', 'spread': '0.7', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 months', 'description': 'Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 48 months as determined by echo core laboratory.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Internal Dimension Diastole (LVIDd)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}, {'value': '115', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'spread': '1.0', 'groupId': 'OG002'}, {'value': '5.3', 'spread': '0.8', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 months', 'description': 'Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 60 months as determined by echo core laboratory.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Internal Dimension Systole (LVIDs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '542', 'groupId': 'OG002'}, {'value': '242', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '3.7', 'spread': '0.8', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days', 'description': 'Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to discharge or 30 days as determined by echo core laboratory.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Internal Dimension Systole (LVIDs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '377', 'groupId': 'OG002'}, {'value': '189', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '3.6', 'spread': '0.9', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 12 months as determined by echo core laboratory.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Internal Dimension Systole (LVIDs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}, {'value': '147', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '3.6', 'spread': '0.9', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 24 months as determined by echo core laboratory.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Internal Dimension Systole (LVIDs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '143', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '3.6', 'spread': '1.0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36 months', 'description': 'Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 36 months as determined by echo core laboratory.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Internal Dimension Systole (LVIDs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'spread': '1.4', 'groupId': 'OG002'}, {'value': '3.6', 'spread': '0.8', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 months', 'description': 'Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 48 months as determined by echo core laboratory.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Internal Dimension Systole (LVIDs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '3.7', 'spread': '1.0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 months', 'description': 'Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 60 months as determined by echo core laboratory.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Ejection Fraction (LVEF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '514', 'groupId': 'OG002'}, {'value': '231', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.9', 'spread': '15.5', 'groupId': 'OG000'}, {'value': '59.4', 'spread': '10.8', 'groupId': 'OG001'}, {'value': '44.7', 'spread': '13.1', 'groupId': 'OG002'}, {'value': '53.0', 'spread': '11.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days', 'description': 'Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to discharge or 30 days as determined by echo core laboratory.', 'unitOfMeasure': 'percentage of ejection fraction', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Ejection Fraction (LVEF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '355', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.0', 'spread': '15.6', 'groupId': 'OG000'}, {'value': '47.2', 'spread': '14.0', 'groupId': 'OG002'}, {'value': '53.9', 'spread': '11.5', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 12 months as determined by echo core laboratory.', 'unitOfMeasure': 'percentage of ejection fraction', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Ejection Fraction (LVEF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}, {'value': '153', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.0', 'spread': '13.9', 'groupId': 'OG000'}, {'value': '46.1', 'spread': '14.2', 'groupId': 'OG002'}, {'value': '54.4', 'spread': '11.8', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 24 months as determined by echo core laboratory.', 'unitOfMeasure': 'percentage of ejection fraction', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Ejection Fraction (LVEF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}, {'value': '141', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.5', 'spread': '17.4', 'groupId': 'OG000'}, {'value': '45.9', 'spread': '15.0', 'groupId': 'OG002'}, {'value': '55.5', 'spread': '12.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36 months', 'description': 'Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 36 months as determined by echo core laboratory.', 'unitOfMeasure': 'percentage of ejection fraction', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Ejection Fraction (LVEF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.9', 'spread': '14.6', 'groupId': 'OG002'}, {'value': '58.2', 'spread': '8.5', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 months', 'description': 'Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 48 months as determined by echo core laboratory.', 'unitOfMeasure': 'percentage of ejection fraction', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Ejection Fraction (LVEF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.3', 'spread': '14.6', 'groupId': 'OG002'}, {'value': '55.5', 'spread': '11.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 months', 'description': 'Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 60 months as determined by echo core laboratory.', 'unitOfMeasure': 'percentage of ejection fraction', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Septal-Lateral Annular Dimension Diastole (SLADd)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '479', 'groupId': 'OG002'}, {'value': '216', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '3.8', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '3.8', 'spread': '0.5', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days', 'description': 'Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to discharge or 30 days as determined by echo core laboratory.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Septal-Lateral Annular Dimension Diastole (SLADd)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '324', 'groupId': 'OG002'}, {'value': '160', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '3.8', 'spread': '0.5', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 12 months as determined by echo core laboratory.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Septal-Lateral Annular Dimension Diastole (SLADd)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '173', 'groupId': 'OG002'}, {'value': '133', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '3.8', 'spread': '0.5', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 24 months as determined by echo core laboratory.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Septal-Lateral Annular Dimension Diastole (SLADd)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '189', 'groupId': 'OG002'}, {'value': '126', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '4.0', 'spread': '0.5', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36 months', 'description': 'Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 36 months as determined by echo core laboratory.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Septal-Lateral Annular Dimension Diastole (SLADd)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '4.1', 'spread': '0.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 months', 'description': 'Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 48 months as determined by echo core laboratory.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Septal-Lateral Annular Dimension Diastole (SLADd)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '99', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '4.0', 'spread': '0.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 months', 'description': 'Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 60 months as determined by echo core laboratory.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Septal-Lateral Annular Dimension Systole (SLADs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '472', 'groupId': 'OG002'}, {'value': '212', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '3.5', 'spread': '0.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days', 'description': 'Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to discharge or 30 days as determined by echo core laboratory.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Septal-Lateral Annular Dimension Systole (SLADs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '317', 'groupId': 'OG002'}, {'value': '157', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '3.4', 'spread': '0.5', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 12 months as determined by echo core laboratory.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Septal-Lateral Annular Dimension Systole (SLADs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '131', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '3.4', 'spread': '0.5', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 24 months as determined by echo core laboratory.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Septal-Lateral Annular Dimension Systole (SLADs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '186', 'groupId': 'OG002'}, {'value': '123', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '3.4', 'spread': '0.5', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36 months', 'description': 'Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 36 months as determined by echo core laboratory.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Septal-Lateral Annular Dimension Systole (SLADs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '3.5', 'spread': '0.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 months', 'description': 'Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 48 months as determined by echo core laboratory.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Septal-Lateral Annular Dimension Systole (SLADs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '3.5', 'spread': '0.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 months', 'description': 'Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 60 months as determined by echo core laboratory.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': '36-Item Short Form Health Survey (SF-36) Quality of Life Change From Baseline to 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'title': 'Physical Component Summary', 'categories': [{'measurements': [{'value': '7.6', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '38.3', 'spread': '10.0', 'groupId': 'OG001'}, {'value': '40.7', 'spread': '9.6', 'groupId': 'OG002'}]}]}, {'title': 'Mental Component Summary', 'categories': [{'measurements': [{'value': '5.3', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '49.3', 'spread': '12.0', 'groupId': 'OG001'}, {'value': '52.5', 'spread': '10.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score PCS) \\& mental health status (Mental Component Score MCS) in relation to 8 health concepts:\n\n* Physical functioning\n* Role limitations due to physical or\n* Emotional health\n* Bodily pain\n* General health perceptions\n* Vitality\n* Social functioning\n* General mental health\n\nResponses to each of the SF-36 items are scored and expressed as a score on a 0-100 scale (0% in a domain represents the poorest possible QOL\\&100% indicates full QOL).Higher scores represent better self-perceived health.\n\nThe physical \\& mental functions were assessed by the Physical Component Summary (PCS) score \\& Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS\\&MCS norms for 65-75 year old are 44 \\& 52, respectively while the norms for CHF population are 31 \\& 46, respectively.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'EU arm participants were not analyzed due to the serious/life-threatening conditions,SF-36 QOL data was not collected on all patients at baseline. Therefore, paired data at 30 days were not available for EU arm.\n\nThe number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': '36-Item Short Form Health Survey (SF-36) Quality of Life Change From Baseline to 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '332', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'title': 'Physical Component Summary', 'categories': [{'measurements': [{'value': '7.2', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '38.9', 'spread': '10.6', 'groupId': 'OG001'}, {'value': '43.2', 'spread': '10.6', 'groupId': 'OG002'}]}]}, {'title': 'Mental Component Summary', 'categories': [{'measurements': [{'value': '6.7', 'spread': '12.0', 'groupId': 'OG000'}, {'value': '50.3', 'spread': '11.9', 'groupId': 'OG001'}, {'value': '51.3', 'spread': '10.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score PCS) \\& mental health status (Mental Component Score MCS) in relation to 8 health concepts:\n\n* Physical functioning\n* Role limitations due to physical or\n* Emotional health\n* Bodily pain\n* General health perceptions\n* Vitality\n* Social functioning\n* General mental health\n\nResponses to each of the SF-36 items are scored and expressed as a score on a 0-100 scale (0% in a domain represents the poorest possible QOL\\&100% indicates full QOL).Higher scores represent better self-perceived health.\n\nThe physical \\& mental functions were assessed by the Physical Component Summary (PCS) score \\& Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS\\&MCS norms for 65-75 year old are 44 \\& 52, respectively while the norms for CHF population are 31 \\& 46, respectively.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'EU arm participants were not analyzed due to the serious/life-threatening conditions, QOL data was not collected on all patients at baseline. Therefore, paired data at 1 year were not available for EU arm.\n\nThe number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in 6-Minute Walk Test (6MWT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '243.1', 'spread': '124.6', 'groupId': 'OG000'}, {'value': '237.8', 'spread': '141.9', 'groupId': 'OG001'}, {'value': '386.7', 'spread': '396.8', 'groupId': 'OG002'}]}]}, {'title': '30 Days', 'categories': [{'measurements': [{'value': '296.6', 'spread': '186.8', 'groupId': 'OG000'}, {'value': '278.8', 'spread': '162.7', 'groupId': 'OG001'}, {'value': '428.9', 'spread': '296.4', 'groupId': 'OG002'}]}]}, {'title': 'Difference', 'categories': [{'measurements': [{'value': '53.4', 'spread': '131.4', 'groupId': 'OG000'}, {'value': '40.9', 'spread': '108.6', 'groupId': 'OG001'}, {'value': '42.1', 'spread': '293.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Baseline and 30 Days', 'description': "Defined as a cardiopulmonary function test that measures a patient's exercise capacity by the distance he or she can walk in six minutes.", 'unitOfMeasure': 'Meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'EU arm participants were not analyzed due to serious/life-threatening conditions, the 6MWT was not administered to all patients at baseline.Therefore,paired data at 30 days were not available for EU arm.\n\nThe number of participants analyzed includes subjects who had available follow up data at that time frame in CU, HR and Non-HR arms.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in 6-Minute Walk Test (6MWT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '252.0', 'spread': '142.5', 'groupId': 'OG000'}, {'value': '413.6', 'spread': '406.4', 'groupId': 'OG001'}]}]}, {'title': '6 Months', 'categories': [{'measurements': [{'value': '283.8', 'spread': '147.9', 'groupId': 'OG000'}, {'value': '392.8', 'spread': '245.1', 'groupId': 'OG001'}]}]}, {'title': 'Difference', 'categories': [{'measurements': [{'value': '31.8', 'spread': '134.7', 'groupId': 'OG000'}, {'value': '-20.9', 'spread': '333.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Baseline and 6 months', 'description': "Defined as a cardiopulmonary function test that measures a patient's exercise capacity by the distance he or she can walk in six minutes.", 'unitOfMeasure': 'Meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'EU and CU arm participants were not analyzed due to serious/life-threatening conditions, the 6MWT was not administered to all patients at baseline.Therefore, paired data at 6 months were not available for EU and CU arm.\n\nThe number of participants analyzed includes subjects who had available follow up data at that time frame HR and Non-HR arms.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in 6-Minute Walk Test (6MWT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG001', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'OG002', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '267.4', 'spread': '115.3', 'groupId': 'OG000'}, {'value': '261.4', 'spread': '142.2', 'groupId': 'OG001'}, {'value': '408.8', 'spread': '380.3', 'groupId': 'OG002'}]}]}, {'title': '12 Months', 'categories': [{'measurements': [{'value': '291.4', 'spread': '142.0', 'groupId': 'OG000'}, {'value': '296.6', 'spread': '129.9', 'groupId': 'OG001'}, {'value': '392.6', 'spread': '211.1', 'groupId': 'OG002'}]}]}, {'title': 'Difference', 'categories': [{'measurements': [{'value': '24.0', 'spread': '112.8', 'groupId': 'OG000'}, {'value': '35.2', 'spread': '155.7', 'groupId': 'OG001'}, {'value': '-16.2', 'spread': '339.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Baseline and 12 months', 'description': "Defined as a cardiopulmonary function test that measures a patient's exercise capacity by the distance he or she can walk in six minutes.", 'unitOfMeasure': 'Meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'EU arm participants were not analyzed due to serious/life-threatening conditions, the 6MWT was not administered to all patients at baseline.Therefore, paired data at 1 year were not available for EU arm.\n\nThe number of participants analyzed includes subjects who had available follow up data at that time frame in CU, HR and Non-HR arms.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'FG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'FG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'FG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM.\n\nThe patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '628'}, {'groupId': 'FG003', 'numSubjects': '271'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '141'}, {'groupId': 'FG003', 'numSubjects': '138'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '487'}, {'groupId': 'FG003', 'numSubjects': '133'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '379'}, {'groupId': 'FG003', 'numSubjects': '96'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '70'}, {'groupId': 'FG003', 'numSubjects': '30'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Expected', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Not due', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'As of February 13, 2018, a total of 59 Compassionate Use and 7 Emergency Use patients have undergone MitraClip procedure between 14 Dec 2010 and 22 Feb 2013. A total of 628 patients in the High Risk arm between January 22, 2009 and December 19, 2013 and 271 patients in the Non-High Risk arm were enrolled between January 22, 2009 and April 14, 2011.', 'preAssignmentDetails': 'Patients who did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either EU or CU.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '628', 'groupId': 'BG002'}, {'value': '271', 'groupId': 'BG003'}, {'value': '965', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'BG001', 'title': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'BG002', 'title': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'BG003', 'title': 'Non-high Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).\n\nIf a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM.\n\nThe patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '125', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}, {'value': '230', 'groupId': 'BG003'}, {'value': '840', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '75.2', 'spread': '9.2', 'groupId': 'BG000'}, {'value': '78.6', 'spread': '11.1', 'groupId': 'BG001'}, {'value': '76.7', 'spread': '10.7', 'groupId': 'BG002'}, {'value': '73.9', 'spread': '11.2', 'groupId': 'BG003'}, {'value': '75.5', 'spread': '9.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '253', 'groupId': 'BG002'}, {'value': '127', 'groupId': 'BG003'}, {'value': '400', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '375', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}, {'value': '565', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '594', 'groupId': 'BG002'}, {'value': '262', 'groupId': 'BG003'}, {'value': '919', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '563', 'groupId': 'BG002'}, {'value': '246', 'groupId': 'BG003'}, {'value': '869', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '628', 'groupId': 'BG002'}, {'value': '271', 'groupId': 'BG003'}, {'value': '66', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 965}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-05', 'studyFirstSubmitDate': '2013-08-27', 'resultsFirstSubmitDate': '2016-11-17', 'studyFirstSubmitQcDate': '2013-08-27', 'lastUpdatePostDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-18', 'studyFirstPostDateStruct': {'date': '2013-08-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': '36-Item Short Form Health Survey (SF-36) Quality of Life Change From Baseline to 30 Days', 'timeFrame': '30 days', 'description': 'The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score PCS) \\& mental health status (Mental Component Score MCS) in relation to 8 health concepts:\n\n* Physical functioning\n* Role limitations due to physical or\n* Emotional health\n* Bodily pain\n* General health perceptions\n* Vitality\n* Social functioning\n* General mental health\n\nResponses to each of the SF-36 items are scored and expressed as a score on a 0-100 scale (0% in a domain represents the poorest possible QOL\\&100% indicates full QOL).Higher scores represent better self-perceived health.\n\nThe physical \\& mental functions were assessed by the Physical Component Summary (PCS) score \\& Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS\\&MCS norms for 65-75 year old are 44 \\& 52, respectively while the norms for CHF population are 31 \\& 46, respectively.'}, {'measure': '36-Item Short Form Health Survey (SF-36) Quality of Life Change From Baseline to 12 Months', 'timeFrame': '12 months', 'description': 'The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score PCS) \\& mental health status (Mental Component Score MCS) in relation to 8 health concepts:\n\n* Physical functioning\n* Role limitations due to physical or\n* Emotional health\n* Bodily pain\n* General health perceptions\n* Vitality\n* Social functioning\n* General mental health\n\nResponses to each of the SF-36 items are scored and expressed as a score on a 0-100 scale (0% in a domain represents the poorest possible QOL\\&100% indicates full QOL).Higher scores represent better self-perceived health.\n\nThe physical \\& mental functions were assessed by the Physical Component Summary (PCS) score \\& Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS\\&MCS norms for 65-75 year old are 44 \\& 52, respectively while the norms for CHF population are 31 \\& 46, respectively.'}, {'measure': 'Change in 6-Minute Walk Test (6MWT)', 'timeFrame': 'At Baseline and 30 Days', 'description': "Defined as a cardiopulmonary function test that measures a patient's exercise capacity by the distance he or she can walk in six minutes."}, {'measure': 'Change in 6-Minute Walk Test (6MWT)', 'timeFrame': 'At Baseline and 6 months', 'description': "Defined as a cardiopulmonary function test that measures a patient's exercise capacity by the distance he or she can walk in six minutes."}, {'measure': 'Change in 6-Minute Walk Test (6MWT)', 'timeFrame': 'At Baseline and 12 months', 'description': "Defined as a cardiopulmonary function test that measures a patient's exercise capacity by the distance he or she can walk in six minutes."}], 'primaryOutcomes': [{'measure': 'Number of Participants With Major Adverse Events', 'timeFrame': '30 days', 'description': 'A combined clinical endpoint of death, myocardial infarction (MI), re-operation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, gastro-intestinal (GI) complication requiring surgery, new onset of permanent atrial fibrillation, septicemia and transfusion of 2 or more units of blood.'}, {'measure': 'Number of Participants With Major Adverse Events', 'timeFrame': '12 months', 'description': 'A combined clinical endpoint of death, myocardial infarction (MI), re-operation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia and transfusion of 2 or more units of blood.'}, {'measure': 'Number of Participants With 12-Month Efficacy', 'timeFrame': '12 months', 'description': 'Defined as freedom from: Surgery for Mitral Regurgitation (MR) or Valve Dysfunction, death, and MR \\> 2+ (moderate to severe (3+) or severe MR (4+)).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Serious Adverse Events', 'timeFrame': '30 days', 'description': 'The definition of a serious adverse event is an event that is fatal or life threatening, results in persistent or significant disability, requires intervention to prevent permanent impairment/damage, or an event that results in congenital anomaly, malignancy, hospital admission or prolongation of hospitalization.'}, {'measure': 'Number of Participants With Serious Adverse Events', 'timeFrame': '12 months', 'description': 'The definition of a serious adverse event is an event that is fatal or life threatening, results in persistent or significant disability, requires intervention to prevent permanent impairment/damage, or an event that results in congenital anomaly, malignancy, hospital admission or prolongation of hospitalization.'}, {'measure': 'Number of Participants With Clinically Significant Atrial Septal Defect (ASD)', 'timeFrame': '30 days', 'description': 'Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.'}, {'measure': 'Number of Participants With Clinically Significant Atrial Septal Defect (ASD)', 'timeFrame': '12 months', 'description': 'Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.'}, {'measure': 'Number of Participants With Major Adverse Events (MAE) in Patients Over 75 Years of Age', 'timeFrame': '30 days', 'description': 'MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.'}, {'measure': 'Number of Participants With Major Adverse Events in Patients Over 75 Years of Age', 'timeFrame': '12 Months', 'description': 'MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.'}, {'measure': 'Number of Participants With Major Adverse Events in Patients Over 75 Years of Age', 'timeFrame': '2 years', 'description': 'MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.'}, {'measure': 'Number of Participants With Major Adverse Events in Patients Over 75 Years of Age', 'timeFrame': '3 years', 'description': 'MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.'}, {'measure': 'Number of Participants With Major Adverse Events in Patients Over 75 Years of Age', 'timeFrame': '4 years', 'description': 'MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.'}, {'measure': 'Number of Participants With Major Adverse Events in Patients Over 75 Years of Age', 'timeFrame': '5 years', 'description': 'MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.'}, {'measure': 'Number of Participants With Acute Procedural Success', 'timeFrame': 'At discharge (an average of ≤ 12.3 days post-index procedure)', 'description': 'Defined as successful implantation of the Clip(s) with resulting MR severity of 2+ or less as determined by the echocardiographic assessment at discharge. The 30-day echocardiogram will be used if the discharge echocardiogram is unavailable or uninterpretable, providing the patient has not undergone subsequent surgery after attempted clip.'}, {'measure': 'Number of Participants With Procedural Success', 'timeFrame': '30 days', 'description': 'Defined as successful implantation of the Clip(s) with resulting MR severity of 2+ of less at discharge or a 1 grade MR reduction at discharge accompanied by a 1 level reduction in NYHA at 30 days.'}, {'measure': 'Number of Participants With Clinical Durability', 'timeFrame': '12 months', 'description': 'Defined as the proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that at 12 months have not required surgery for valve dysfunction and meet either of the following: 1) MR severity grade of 2+ or less or 2) a one grade reduction in MR severity compared to baseline accompanied by at least a one level reduction in NYHA at 12 months.'}, {'measure': 'Number of Participants With Clip Implant Rate', 'timeFrame': 'On the day of index procedure (≤1 day)', 'description': 'Defined as the procedural rate of successful delivery and deployment of Clip implants with echocardiographic evidence of leaflet approximation and retrieval of the investigational delivery catheter.'}, {'measure': 'Procedure Time', 'timeFrame': 'On the day of index procedure', 'description': 'The mean procedure time is defined as the start time of the transseptal procedure to the time the steerable guide catheter (SGC) is removed.'}, {'measure': 'Device Time', 'timeFrame': 'On the day of index procedure', 'description': 'Device time is defined as the time of insertion of the Steerable Guide Catheter (SGC) to the time the MitraClip delivery catheter is retracted into the SGC.'}, {'measure': 'Fluoroscopy Duration', 'timeFrame': 'On the day of index procedure', 'description': 'Mean fluoroscopy duration during the MitraClip procedure.'}, {'measure': 'Number of Participants With MitraClip Devices Implanted', 'timeFrame': 'On the day of index procedure', 'description': 'The distribution of number of MitraClip devices implanted in patients.'}, {'measure': 'Post-Procedure Intensive Care Unit (ICU)/ Critical Care Unit (CCU)/ Post-anesthesia Care Unit (PACU) Duration', 'timeFrame': 'At discharge (an average of ≤ 12.3 days post-index procedure).', 'description': 'Defined as the number of hours for which patients are in an intensive care unit or step down unit before discharge or moving to a standard care unit.'}, {'measure': 'Post-Procedure Length of Hospital Stay', 'timeFrame': 'At discharge (an average of ≤ 12.3 days post-index procedure).', 'description': 'Defined as the number of days from the end of the procedure until the patient is discharged from the hospital. This does not include time in a nursing or skilled care facility.'}, {'measure': 'Number of Participants Experiencing Death', 'timeFrame': '12 months visit window (410 days)', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)\n\nNon-cardiac death is defined as a death not due to cardiac causes (as defined above).'}, {'measure': 'Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility', 'timeFrame': 'At discharge (an average of ≤ 12.3 days post-index procedure)'}, {'measure': 'Number of Participants With Hospital Re-admissions', 'timeFrame': '30 days', 'description': 'Defined as re-admission of patients to the hospital following discharge from the Clip procedure.'}, {'measure': 'Number of Participants With Device Embolization or Single Leaflet Device Attachment (SLDA)', 'timeFrame': '0 to 5 years', 'description': 'A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.'}, {'measure': 'Number of Participants With Mitral Stenosis', 'timeFrame': '0 to 5 years', 'description': 'Mitral stenosis is a key safety consideration assessed after implantation of the MitraClip device. It is defined as Mitral Valve Area (MVA) less than 1.5 cm\\^2 as assessed by the Echocardiography Core Laboratory (ECL).'}, {'measure': 'Number of Participants With Mitral Regurgitation (MR) Severity', 'timeFrame': '30 days(Follow-up)', 'description': 'Paired site-assessed Mitral regurgitation severity between baseline and 30 days using echocardiography.\n\nMR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.'}, {'measure': 'Number of Participants With MR Severity', 'timeFrame': '12 months', 'description': 'Paired site-assessed Mitral regurgitation severity between baseline and 12 months using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.'}, {'measure': 'Number of Participants With MR Severity', 'timeFrame': '2 years', 'description': 'Paired site-assessed Mitral regurgitation severity between baseline and 2 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.'}, {'measure': 'Number of Participants With MR Severity', 'timeFrame': '3 years', 'description': 'Paired site-assessed Mitral regurgitation severity between baseline and 3 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.'}, {'measure': 'Number of Participants With MR Severity', 'timeFrame': '4 years', 'description': 'Paired site-assessed Mitral regurgitation severity between baseline and 4 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.'}, {'measure': 'Number of Participants With MR Severity', 'timeFrame': '5 years', 'description': 'Paired site-assessed Mitral regurgitation severity between baseline and 5 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.'}, {'measure': 'Number of Participants With Second Intervention to Place an Additional Mitraclip Device.', 'timeFrame': '139 days post the index procedure', 'description': 'If residual MR was determined to be clinically unacceptable for patients who received only 1 clip during the index procedure, a second intervention to place an additional MitraClip device could be considered.'}, {'measure': 'Number of Participants With Second Intervention to Place an Additional Mitraclip Device.', 'timeFrame': '5 years', 'description': 'If residual MR was determined to be clinically unacceptable for patients who received only 1 clip during the index procedure, a second intervention to place an additional MitraClip device could be considered.'}, {'measure': 'Number of Participants With New York Heart Association (NYHA) Functional Class', 'timeFrame': '30 days', 'description': 'Paired NYHA data from baseline to 30 days. Class I: Patients with cardiac disease but without resulting limitations of physical activity.\n\nClass II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.\n\nClass III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.\n\nClass IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.'}, {'measure': 'Number of Participants With NYHA Functional Class', 'timeFrame': '12 months', 'description': 'Paired NYHA data from baseline to 12 months. Class I: Patients with cardiac disease but without resulting limitations of physical activity.\n\nClass II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.\n\nClass III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.\n\nClass IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.'}, {'measure': 'Number of Participants With NYHA Functional Class', 'timeFrame': '2 years', 'description': 'Paired NYHA data from baseline to 2 years. Class I: Patients with cardiac disease but without resulting limitations of physical activity.\n\nClass II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.\n\nClass III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.\n\nClass IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.'}, {'measure': 'Number of Participants With NYHA Functional Class', 'timeFrame': '3 years', 'description': 'Paired NYHA data from baseline to 3 years. Class I: Patients with cardiac disease but without resulting limitations of physical activity.\n\nClass II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.\n\nClass III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.\n\nClass IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.'}, {'measure': 'Number of Participants With NYHA Functional Class', 'timeFrame': '4 years', 'description': 'Paired NYHA data from baseline to 4 years. Class I: Patients with cardiac disease but without resulting limitations of physical activity.\n\nClass II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.\n\nClass III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.\n\nClass IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.'}, {'measure': 'Number of Participants With NYHA Functional Class', 'timeFrame': '5 years', 'description': 'Paired NYHA data from baseline to 5 years. Class I: Patients with cardiac disease but without resulting limitations of physical activity.\n\nClass II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.\n\nClass III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.\n\nClass IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.'}, {'measure': 'Left Ventricular End-diastolic Volume (LVEDV)', 'timeFrame': 'At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days', 'description': 'Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to discharge or 30 days as determined by echo core laboratory.'}, {'measure': 'Left Ventricular End-diastolic Volume (LVEDV)', 'timeFrame': '12 months', 'description': 'Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 12 months as determined by echo core laboratory.'}, {'measure': 'Left Ventricular End-diastolic Volume (LVEDV)', 'timeFrame': '24 months', 'description': 'Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 24 months as determined by echo core laboratory.'}, {'measure': 'Left Ventricular End-diastolic Volume (LVEDV)', 'timeFrame': '36 months', 'description': 'Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 36 months as determined by echo core laboratory.'}, {'measure': 'Left Ventricular End-diastolic Volume (LVEDV)', 'timeFrame': '48 months', 'description': 'Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 48 months as determined by the echo core laboratory.'}, {'measure': 'Left Ventricular End-diastolic Volume (LVEDV)', 'timeFrame': '60 months', 'description': 'Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 60 months as determined by echo core laboratory.'}, {'measure': 'Left Ventricular End-systolic Volume (LVESV)', 'timeFrame': 'At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days', 'description': 'Paired Left ventricular end-systolic volume (LVESV) data from baseline to discharge or 30 days as determined by echo core laboratory.'}, {'measure': 'Left Ventricular End-systolic Volume (LVESV)', 'timeFrame': '12 months', 'description': 'Paired Left ventricular end-systolic volume (LVESV) data from baseline to 12 months as determined by echo core laboratory.'}, {'measure': 'Left Ventricular End-systolic Volume (LVESV)', 'timeFrame': '24 months', 'description': 'Paired Left ventricular end-systolic volume (LVESV) data from baseline to 24 months as determined by echo core laboratory.'}, {'measure': 'Left Ventricular End-systolic Volume (LVESV)', 'timeFrame': '36 months', 'description': 'Paired Left ventricular end-systolic volume (LVESV) data from baseline to 36 months as determined by echo core laboratory.'}, {'measure': 'Left Ventricular End-systolic Volume (LVESV)', 'timeFrame': '48 months', 'description': 'Paired Left ventricular end-systolic volume (LVESV) data from baseline to 48 months as determined by echo core laboratory.'}, {'measure': 'Left Ventricular End-systolic Volume (LVESV)', 'timeFrame': '60 months', 'description': 'Paired Left ventricular end-systolic volume (LVESV) data from baseline to 60 months as determined by echo core laboratory.'}, {'measure': 'Left Ventricular Internal Dimension Diastole (LVIDd)', 'timeFrame': 'At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days', 'description': 'Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to discharge or 30 days as determined by echo core laboratory.'}, {'measure': 'Left Ventricular Internal Dimension Diastole (LVIDd)', 'timeFrame': '12 months', 'description': 'Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 12 months as determined by echo core laboratory.'}, {'measure': 'Left Ventricular Internal Dimension Diastole (LVIDd)', 'timeFrame': '24 months', 'description': 'Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 24 months as determined by echo core laboratory.'}, {'measure': 'Left Ventricular Internal Dimension Diastole (LVIDd)', 'timeFrame': '36 months', 'description': 'Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 36 months as determined by echo core laboratory.'}, {'measure': 'Left Ventricular Internal Dimension Diastole (LVIDd)', 'timeFrame': '48 months', 'description': 'Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 48 months as determined by echo core laboratory.'}, {'measure': 'Left Ventricular Internal Dimension Diastole (LVIDd)', 'timeFrame': '60 months', 'description': 'Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 60 months as determined by echo core laboratory.'}, {'measure': 'Left Ventricular Internal Dimension Systole (LVIDs)', 'timeFrame': 'At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days', 'description': 'Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to discharge or 30 days as determined by echo core laboratory.'}, {'measure': 'Left Ventricular Internal Dimension Systole (LVIDs)', 'timeFrame': '12 months', 'description': 'Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 12 months as determined by echo core laboratory.'}, {'measure': 'Left Ventricular Internal Dimension Systole (LVIDs)', 'timeFrame': '24 months', 'description': 'Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 24 months as determined by echo core laboratory.'}, {'measure': 'Left Ventricular Internal Dimension Systole (LVIDs)', 'timeFrame': '36 months', 'description': 'Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 36 months as determined by echo core laboratory.'}, {'measure': 'Left Ventricular Internal Dimension Systole (LVIDs)', 'timeFrame': '48 months', 'description': 'Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 48 months as determined by echo core laboratory.'}, {'measure': 'Left Ventricular Internal Dimension Systole (LVIDs)', 'timeFrame': '60 months', 'description': 'Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 60 months as determined by echo core laboratory.'}, {'measure': 'Left Ventricular Ejection Fraction (LVEF)', 'timeFrame': 'At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days', 'description': 'Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to discharge or 30 days as determined by echo core laboratory.'}, {'measure': 'Left Ventricular Ejection Fraction (LVEF)', 'timeFrame': '12 months', 'description': 'Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 12 months as determined by echo core laboratory.'}, {'measure': 'Left Ventricular Ejection Fraction (LVEF)', 'timeFrame': '24 months', 'description': 'Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 24 months as determined by echo core laboratory.'}, {'measure': 'Left Ventricular Ejection Fraction (LVEF)', 'timeFrame': '36 months', 'description': 'Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 36 months as determined by echo core laboratory.'}, {'measure': 'Left Ventricular Ejection Fraction (LVEF)', 'timeFrame': '48 months', 'description': 'Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 48 months as determined by echo core laboratory.'}, {'measure': 'Left Ventricular Ejection Fraction (LVEF)', 'timeFrame': '60 months', 'description': 'Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 60 months as determined by echo core laboratory.'}, {'measure': 'Septal-Lateral Annular Dimension Diastole (SLADd)', 'timeFrame': 'At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days', 'description': 'Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to discharge or 30 days as determined by echo core laboratory.'}, {'measure': 'Septal-Lateral Annular Dimension Diastole (SLADd)', 'timeFrame': '12 months', 'description': 'Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 12 months as determined by echo core laboratory.'}, {'measure': 'Septal-Lateral Annular Dimension Diastole (SLADd)', 'timeFrame': '24 months', 'description': 'Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 24 months as determined by echo core laboratory.'}, {'measure': 'Septal-Lateral Annular Dimension Diastole (SLADd)', 'timeFrame': '36 months', 'description': 'Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 36 months as determined by echo core laboratory.'}, {'measure': 'Septal-Lateral Annular Dimension Diastole (SLADd)', 'timeFrame': '48 months', 'description': 'Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 48 months as determined by echo core laboratory.'}, {'measure': 'Septal-Lateral Annular Dimension Diastole (SLADd)', 'timeFrame': '60 months', 'description': 'Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 60 months as determined by echo core laboratory.'}, {'measure': 'Septal-Lateral Annular Dimension Systole (SLADs)', 'timeFrame': 'At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days', 'description': 'Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to discharge or 30 days as determined by echo core laboratory.'}, {'measure': 'Septal-Lateral Annular Dimension Systole (SLADs)', 'timeFrame': '12 months', 'description': 'Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 12 months as determined by echo core laboratory.'}, {'measure': 'Septal-Lateral Annular Dimension Systole (SLADs)', 'timeFrame': '24 months', 'description': 'Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 24 months as determined by echo core laboratory.'}, {'measure': 'Septal-Lateral Annular Dimension Systole (SLADs)', 'timeFrame': '36 months', 'description': 'Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 36 months as determined by echo core laboratory.'}, {'measure': 'Septal-Lateral Annular Dimension Systole (SLADs)', 'timeFrame': '48 months', 'description': 'Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 48 months as determined by echo core laboratory.'}, {'measure': 'Septal-Lateral Annular Dimension Systole (SLADs)', 'timeFrame': '60 months', 'description': 'Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 60 months as determined by echo core laboratory.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Mitral Valve Insufficiency', 'Mitral Valve Regurgitation', 'Mitral Valve Incompetence', 'Mitral Regurgitation', 'Mitral Insufficiency', 'Mitral Valve', 'Mitral Regurgitation (MR)', 'Mitral Valve Prolapse', 'Edge to Edge (E2E)', 'Alfieri Technique', 'MitraClip', 'Functional MR', 'Degenerative MR', 'Echocardiogram', 'Coronary Artery Disease (CAD)', 'Heart Failure', 'Heart Attack', 'EVEREST', 'EVEREST I', 'EVEREST II', 'REALISM'], 'conditions': ['Mitral Valve Insufficiency', 'Mitral Valve Regurgitation', 'Mitral Valve Incompetence', 'Mitral Regurgitation', 'Mitral Insufficiency']}, 'referencesModule': {'references': [{'pmid': '21741608', 'type': 'RESULT', 'citation': 'Grayburn PA, Roberts BJ, Aston S, Anwar A, Hebeler RF Jr, Brown DL, Mack MJ. Mechanism and severity of mitral regurgitation by transesophageal echocardiography in patients referred for percutaneous valve repair. Am J Cardiol. 2011 Sep 15;108(6):882-7. doi: 10.1016/j.amjcard.2011.05.013. Epub 2011 Jul 7.'}, {'pmid': '23608290', 'type': 'RESULT', 'citation': 'Pope NH, Lim S, Ailawadi G. Late calcific mitral stenosis after MitraClip procedure in a dialysis-dependent patient. Ann Thorac Surg. 2013 May;95(5):e113-4. doi: 10.1016/j.athoracsur.2012.10.067.'}, {'pmid': '25011722', 'type': 'RESULT', 'citation': 'Glower DD, Kar S, Trento A, Lim DS, Bajwa T, Quesada R, Whitlow PL, Rinaldi MJ, Grayburn P, Mack MJ, Mauri L, McCarthy PM, Feldman T. Percutaneous mitral valve repair for mitral regurgitation in high-risk patients: results of the EVEREST II study. J Am Coll Cardiol. 2014 Jul 15;64(2):172-81. doi: 10.1016/j.jacc.2013.12.062.'}, {'pmid': '30586701', 'type': 'DERIVED', 'citation': 'Ailawadi G, Lim DS, Mack MJ, Trento A, Kar S, Grayburn PA, Glower DD, Wang A, Foster E, Qasim A, Weissman NJ, Ellis J, Crosson L, Fan F, Kron IL, Pearson PJ, Feldman T; EVEREST II Investigators. One-Year Outcomes After MitraClip for Functional Mitral Regurgitation. Circulation. 2019 Jan 2;139(1):37-47. doi: 10.1161/CIRCULATIONAHA.117.031733.'}, {'pmid': '25593120', 'type': 'DERIVED', 'citation': 'Wang A, Sangli C, Lim S, Ailawadi G, Kar S, Herrmann HC, Grayburn P, Foster E, Weissman NJ, Glower D, Feldman T. Evaluation of renal function before and after percutaneous mitral valve repair. Circ Cardiovasc Interv. 2015 Jan;8(1):e001349. doi: 10.1161/CIRCINTERVENTIONS.113.001349.'}, {'pmid': '24184254', 'type': 'DERIVED', 'citation': 'Lim DS, Reynolds MR, Feldman T, Kar S, Herrmann HC, Wang A, Whitlow PL, Gray WA, Grayburn P, Mack MJ, Glower DD. Improved functional status and quality of life in prohibitive surgical risk patients with degenerative mitral regurgitation after transcatheter mitral valve repair. J Am Coll Cardiol. 2014 Jul 15;64(2):182-92. doi: 10.1016/j.jacc.2013.10.021. Epub 2013 Oct 31.'}], 'seeAlsoLinks': [{'url': 'https://www.vascular.abbott/us/homepage.html', 'label': 'Web site listing study sites and describing mitral regurgitation, symptoms, clinical consequences and treatments'}]}, 'descriptionModule': {'briefSummary': 'Prospective, multicenter, continued access registry of the MitraClip® Cardiovascular Valve Repair System in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6-month, 12-month, 36-month and 60-month clinical follow-up. The study consists of two arms: a High Risk group (NCT01940120) and a Non-High Risk group (NCT00209274) . Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU).', 'detailedDescription': 'The EVEREST II REALISM study (REALISM study) is a continued access registry designed for continued data collection on the use of Abbott Vascular\'s MitraClip System (MitraClip® Device) under more "real world" conditions. After the completion of enrollment in the pivotal EVEREST II Randomized Controlled Trial (RCT) NCT00209274 and EVEREST II High Risk Registry Study NCT01940120, continued access to the technology was warranted to collect additional safety and effectiveness data on the MitraClip® Device. This continued access study was approved by FDA on November 21, 2008 (G030064). There are two arms (High Risk and Non-High Risk) in the REALISM study. Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). Enrollment in the Non-High Risk arm of the study concluded on April 14, 2011 and enrollment in the High Risk arm concluded on December 19, 2013.\n\nREALISM is a prospective, multi-center, study of the safety and effectiveness of an endovascular approach to the treatment of mitral valve regurgitation using the Evalve Cardiovascular Valve Repair System (MitraClip® implant). Patients with moderate-to-severe (3+) or severe (4+) mitral regurgitation (MR), as determined by the site from a transthoracic echocardiogram (TTE), were considered for enrollment in this study. The TTE and a transesophageal echocardiogram (TEE) are used to assess eligibility criteria for MR severity, valve anatomy and left ventricular parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patients screened in EVEREST II REALISM Study will first be screened for high risk (HR) status and enrolled into the HR arm if they meet eligibility for this arm of the study. If they do not meet eligibility for the HR arm, patients will be further screened for eligibility for enrollment into the non-high risk (NHR) arm.\n\nKey Inclusion Criteria:\n\n* The primary regurgitant jet originates from malcoaptation of the A2 and P2 scallops of the mitral valve (MV)\n* Male or non-pregnant female\n* Trans-septal catheterization is determined to be feasible by the treating physician\n\nHigh Risk Arm:\n\n* Predicted procedural mortality risk calculated using the STS surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a HR surgical candidate due to the presence of one of the following indications:\n\n 1. Porcelain aorta or mobile ascending aortic atheroma\n 2. Post-radiation mediastinum\n 3. Previous mediastinitis\n 4. Functional MR with EF \\<40\n 5. Over 75 years old with EF\\<40\n 6. Re-operation with patent grafts\n 7. Two or more prior chest surgeries\n 8. Hepatic cirrhosis\n 9. Three or more of the following STS high risk factors 9.1 Creatinine \\>2.5 mg/dL 9.2 Prior chest surgery 9.3 Age over 75 9.4 EF\\<35\n* Symptomatic moderate to severe (3+) or severe (4+) chronic MR and in the judgment of the investigator intervention to reduce MR is likely to provide symptomatic relief for the patient\n* American Society of Anesthesiologists (ASA) physical status classification of ASA IV or lower\n\nNon-High Risk Arm:\n\n* Moderate to severe (3+) or severe (4+) chronic MV regurgitation and:\n\n 1\\. Symptomatic with \\>25% LVEF and LVESD ≤55mm or, 2. Asymptomatic with one or more of the following: i. Left Ventricular Ejection Fraction (LVEF) 25% to 60% ii. Left Ventricular End-Systolic Diameter (LVESD) ≥40 mm iii. New onset of Atrial fibrillation (AFib) iv. Pulmonary arterial systolic pressure (PASP) \\>50 mmHg at rest or \\>60 mmHg with exercise\n* Candidate for MV repair or replacement surgery, including cardiopulmonary bypass\n\nKey Exclusion Criteria:\n\n* Evidence of an Acute Myocardial Infarction (AMI) in the prior 12 weeks of the intended treatment\n* In the judgment of the Investigator, the femoral vein cannot accommodate a 24 French scale (F) catheter or the presence of an inferior vena cava (IVC) filter would interfere with advancement of the catheter or ipsilateral Deep Venous Thrombus (DVT) is present\n* MV orifice area \\<4.0 cm2\n* If leaflet flail is present:\n\n 1. Flail Width ≥15 mm, or\n 2. Flail Gap ≥10 mm.\n* If leaflet tethering is present:\n\n 1\\. Vertical coaptation length \\<2 mm\n* Leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in MR. This may include:\n\n 1. Evidence of calcification in the grasping area of the A2 and/or P2 scallops\n 2. Presence of a significant cleft of A2 or P2 scallops\n 3. More than one anatomic criteria dimensionally near the exclusion limits\n 4. Bileaflet flail or severe bileaflet prolapse\n 5. Lack of both primary and secondary chordal support\n* Hemodynamic instability (systolic pressure \\<90 mmHg without afterload reduction or cardiogenic shock or the need for inotropic support or intra-aortic balloon pump).\n* Need for emergency surgery for any reason\n* Prior MV surgery or valvuloplasty or any currently implanted mechanical prosthetic valve or currently implanted Ventricular assist device (VAD)\n* Echocardiographic evidence of intracardiac mass, thrombus or vegetation\n* Active endocarditis or active rheumatic heart disease or leaflets degenerated from either endocarditis or rheumatic disease (i.e. noncompliant, perforated)\n* History of bleeding diathesis or coagulopathy or subject will refuse blood transfusions\n* Life expectancy \\<12 months\n* Active infections requiring current antibiotic therapy\n* Patients in whom transesophageal echocardiography (TEE) is contraindicated\n\nHigh Risk Arm:\n\n* EF \\<20%, and/or LVESD \\>60 mm\n\nNon-High Risk Arm:\n\n* The need for any other cardiac surgery\n* Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to the index procedure\n* Severe Left Ventricular (LV) dysfunction (EF \\<25% and/or LVESD \\>55mm)\n* Severe mitral annular calcification\n* Systolic anterior motion of the MV leaflet\n* Hypertrophic cardiomyopathy\n* History of a stroke or documented Transient Ischemic Attack (TIA) within the prior 6 months\n* Upper GI bleeding within the prior 6 months\n* Platelet count \\<75,000 cells/mm³\n* Creatinine \\>2.5mg/dL'}, 'identificationModule': {'nctId': 'NCT01931956', 'acronym': 'REALISM', 'briefTitle': 'Real World Expanded Multicenter Study of the MitraClip® System (REALISM)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'A Continued Access Registry of the Evalve® MitraClip® System: EVEREST II Real World Expanded Multicenter Study of the MitraClip System (REALISM)', 'orgStudyIdInfo': {'id': '0401B'}, 'secondaryIdInfos': [{'id': '0401', 'type': 'OTHER', 'domain': 'Abbott Vascular'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Non-High Risk', 'description': 'Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. This arm was evaluated as a separate study NCT00209274.', 'interventionNames': ['Device: MitraClip® implant']}, {'type': 'EXPERIMENTAL', 'label': 'High Risk', 'description': 'Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. This arm was evaluated as a separate study NCT01940120.', 'interventionNames': ['Device: MitraClip® implant']}, {'type': 'EXPERIMENTAL', 'label': 'Compassionate Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.', 'interventionNames': ['Device: MitraClip® implant']}, {'type': 'EXPERIMENTAL', 'label': 'Emergency Use', 'description': 'Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.', 'interventionNames': ['Device: MitraClip® implant']}], 'interventions': [{'name': 'MitraClip® implant', 'type': 'DEVICE', 'description': 'Percutaneous mitral valve repair using MitraClip implant', 'armGroupLabels': ['Compassionate Use', 'Emergency Use', 'High Risk', 'Non-High Risk']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'El Camino Hospital', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': 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