Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2026-06-20 @ 9:18 PM
Study NCT ID:
NCT01940120
Status:
COMPLETED
Last Update Posted:
2018-11-07
First Post:
2013-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
EVEREST II Pivotal Study High Risk Registry (HRR)
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': 'chithra.sangli@av.abbott.com', 'phone': '650-430-1329', 'title': 'Chithra Sangli', 'organization': 'Abbott Vascular Structural Heart (formerly Evalve, Inc.)'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '5 years', 'eventGroups': [{'id': 'EG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.\n\nPercutaneous mitral valve repair using MitraClip implant: Procedure/Surgery: Mitral valve repair or replacement surgery Repair or replacement of mitral valve', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 77, 'seriousNumAtRisk': 78, 'deathsNumAffected': 25, 'seriousNumAffected': 69}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 26}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hemolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Atrial arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Atrial septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bradyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cardiac disorders: other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Chest pain/Angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 22}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Congestive heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 19}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Myocardial ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Other rhythm disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Peripheral edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 20}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Residual/recurrent magnetic resonance (MR)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Syncope/Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 19}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastrointestinal disorders: Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'General disorders: Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 38}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Generalized weakness/Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Incisional site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Mental disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Metabolic/Endocrine disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Skin/Mucosal/Subcutaneous tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Connective tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 37}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nervous system disorders: Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Transient ischemic attack (TIA)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Renal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 10}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Renal and urinary disorders: Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 12}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Renal insufficiency/Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 15}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bronchial/Lung disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 16}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Respiratory Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Respiratory, thoracic and mediastinal disorders: Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 30}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bleeding complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 34}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Blood pressure complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bruise/Contusion/Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 18}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 19}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hemodynamic instability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 21}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vascular disorders: Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hematologic - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Infection/Bacteremia/Septicemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Atrial arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Atrial septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bradyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cardiac disorders: Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Chest pain/Angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Congestive heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 21}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Heart block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Lead displacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Myocardial ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Other rhythm disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Residual/Recurrent MR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Supraventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Syncope/Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Ventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastrointestinal disorders: Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'General disorders: Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Generalized weakness/Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Metabolic/Endocrine disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Connective tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Intracerebral hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nervous system disorders: Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Neurologic - Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Transient ischemic attack (TIA)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Renal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 9}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Renal and urinary disorders: Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Renal insufficiency/Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 20}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bronchial/lung disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Chronic Obstructive Pulmonary Disease (COPD)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Respiratory - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Respiratory Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Arteriovenous (AV) fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Bleeding complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Deep vein thrombosis (DVT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Embolization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hemodynamic instability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vascular Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vascular disorders: Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Composite Functional and Structural Measures - Freedom From Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint. Death is further divided into 2 categories:\n\nA. Cardiac death is defined as death due to any of the following:\n\n1. Acute myocardial infarction.\n2. Cardiac perforation/pericardial tamponade.\n3. Arrhythmia or conduction abnormality.\n4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure.\n5. Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.\n6. Any death for which a cardiac cause cannot be excluded.\n\nB. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Freedom From Death and Mitral Regurgitation (MR) >2+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'title': 'Primary Analysis', 'categories': [{'measurements': [{'value': '56.4', 'groupId': 'OG000'}]}]}, {'title': 'Worst case Analysis', 'categories': [{'measurements': [{'value': '53.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Kaplan-Meier estimated percentage of patients who are alive and have a mitral regurgitation severity grade of 2+ or less', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinical Measures of Benefit-New York Heart Association (NYHA) Class', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'title': 'NYHA Functional Class I', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'NYHA Functional Class II', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'NYHA Functional Class III', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'NYHA Functional Class IV', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'The major effectiveness endpoint is an assessment of multiple functional and structural measures of benefit including New York Heart Association (NYHA) Class.\n\nClass 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': '71 out of 78 patients (at baseline) were analyzed at 30 days. There were 6 deaths prior to 30 days. So, NYHA at 30 days is missing due to death in 6 patients, and missing due to other reasons in 1 patient.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With New York Heart Association (NYHA) Class', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'title': 'NYHA Functional Class I', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'NYHA Functional Class II', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'NYHA Functional Class III', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'NYHA Functional Class IV', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': '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': 'Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and 2 patients without NYHA Class assessment.'}, {'type': 'PRIMARY', 'title': 'Clinical Measures of Benefit-Quality of Life (QOL) as Measured by Short Form (SF) 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'title': 'PCS', 'categories': [{'measurements': [{'value': '36.1', 'spread': '10.8', 'groupId': 'OG000'}]}]}, {'title': 'MCS', 'categories': [{'measurements': [{'value': '48.7', 'spread': '11.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Standardized quality of life surveys allow physicians to evaluate the effectiveness of different treatment methods and the physical and psychological benefits a patient is likely to receive from a particular treatment.In the EVEREST II HRR,the patients were asked to complete the SF-36 QOL survey at baseline, 30 days and 12 months. The physical \\& mental function were assessed by the Physical Component Summary (PCS) score \\& Mental Component Summary (MCS) score. The PCS \\& MCS norms for 65-75 year olds are 44 and 52 respectively; and 31 \\& 46 for congestive heart failure (CHF) patients respectively. Each scale from the SF-36 is an algebraic sum of responses for all items in that scale.For ease of analysis each scale is then transformed to a 0-100 scale using a formula that converts the lowest \\& highest possible scores to 0 \\& 100 respectively.The scoring of the SF-36 indicates that 0% in a domain represents the poorest possible QoL \\& 100% indicates full QoL.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'PRIMARY', 'title': 'Left Ventricular End Diastolic Volume (LVEDV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '139.7', 'spread': '42.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and LVEDV was not done or un-evaluable in 2 patients.'}, {'type': 'PRIMARY', 'title': 'Left Ventricular End Systolic Volume (LVESV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.2', 'spread': '35.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and LVESV was not done or un-evaluable in 2 patients.'}, {'type': 'PRIMARY', 'title': 'Left Ventricular (LV) Function - Internal Dimension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'title': 'LV Internal Dimension diastole (LVIDd)', 'categories': [{'measurements': [{'value': '5.3', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'LV Internal Dimension systole (LVIDs)', 'categories': [{'measurements': [{'value': '3.8', 'spread': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and LIVDs/LVIDs evaluation was not done or un-evaluable in 2 patients.'}, {'type': 'PRIMARY', 'title': 'Number of Patients With CHF Having Hospitalization During Discharge Through 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Number of patients with incidence of re-hospitalizations for CHF in the 12-months after the MitraClip implant procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Three patients died before discharge and thus do not provide data on post-discharge hospitalizations.'}, {'type': 'PRIMARY', 'title': 'Number of CHF Events Leading to Hospitalizations During Discharge Through 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Incidence of re-hospitalizations for CHF in the 12-months after the MitraClip implant procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Three patients died before discharge and thus do not provide data on post-discharge hospitalizations.'}, {'type': 'PRIMARY', 'title': 'Left Ventricular End Diastolic Volume (LVEDV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '147.9', 'spread': '48.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Discharge or 30 days', 'description': 'Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Left Ventricular End Systolic Volume (LVESV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.3', 'spread': '40.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Discharge or 30 days', 'description': 'Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Left Ventricular (LV) Function - Internal Dimension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'title': 'LV Internal Dimension diastole (LVIDd)', 'categories': [{'measurements': [{'value': '5.4', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'LV Internal Dimension systole (LVIDs)', 'categories': [{'measurements': [{'value': '3.9', 'spread': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Discharge or 30 days', 'description': 'Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Major Adverse Events (MAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective 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'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Major Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective 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'}, {'type': 'SECONDARY', 'title': 'Procedural Freedom From In-hospital MAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 Days', 'description': 'Percutaneous Clip procedure or surgery with no occurrence of in-hospital MAE.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Over 75 Years of Age With MAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective 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': 'Analysis population includes 48 patients who were aged 75 years or older in the study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Over 75 Years of Age With MAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective 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': 'Analysis population includes 48 patients who were aged 75 years or older in the study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Major Vascular Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Defined as the occurrence of any of the following resulting from the index procedure:\n\n* Hematoma at access site \\>6 cm;\n* Retroperitoneal hematoma;\n* Arterial-venous fistula;\n* Symptomatic peripheral ischemia/ nerve injury with clinical signs or symptoms lasting \\>24 hours;\n* Vascular surgical repair at catheter access sites;\n* Pulmonary embolism;\n* Ipsilateral deep vein thrombus; or\n* Access site-related infection requiring intravenous antibiotics and/or extended hospitalization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Major Vascular Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Defined as the occurrence of any of the following resulting from the index procedure:\n\n* Hematoma at access site \\>6 cm;\n* Retroperitoneal hematoma;\n* Arterial-venous fistula;\n* Symptomatic peripheral ischemia/ nerve injury with clinical signs or symptoms lasting \\>24 hours;\n* Vascular surgical repair at catheter access sites;\n* Pulmonary embolism;\n* Ipsilateral deep vein thrombus; or\n* Access site-related infection requiring intravenous antibiotics and/or extended hospitalization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Major Bleeding Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Defined as procedure related bleeding that requires a transfusion of ≥2 units of blood and/or surgical intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Major Bleeding Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Defined as procedure related bleeding that requires a transfusion of ≥2 units of blood and/or surgical intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Non-cerebral Thromboembolism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Defined as any mural thrombus or thromboembolism in the vasculature (excluding central nervous system events) confirmed by standard clinical and laboratory testing and which requires intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Non-cerebral Thromboembolism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Defined as any mural thrombus or thromboembolism in the vasculature (excluding central nervous system events) confirmed by standard clinical and laboratory testing and which requires intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Thrombosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Evidence of formation of an independently moving thrombus on any part of the Clip or any commercially available implant used during surgery by echocardiography or fluoroscopy. If Clip is explanted or an autopsy is performed this diagnosis should be confirmed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Thrombosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Evidence of formation of an independently moving thrombus on any part of the Clip or any commercially available implant used during surgery by echocardiography or fluoroscopy. If Clip is explanted or an autopsy is performed this diagnosis should be confirmed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Hemolysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on two measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Hemolysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on two measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Dysrhythmias', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Includes all new onset atrial fibrillation and heart block requiring placement of a permanent pacemaker.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Dysrhythmias', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Includes all new onset atrial fibrillation and heart block requiring placement of a permanent pacemaker.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Endocarditis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Using Duke Criteria, endocarditis can be confirmed by:\n\nPathological criteria: Endocarditis is confirmed if microorganisms are identified by culture or histology in a vegetation, embolized vegetation, or an intracardiac abscess; or if pathological lesions are observed \\& histologically confirmed showing active endocarditis.\n\nClinical criteria: Endocarditis is confirmed by the presence of 2 major criteria, 1 major plus 3 minor criteria, or 5 minor criteria. Major criteria include persistently +ve blood cultures with the presence of typical organisms for endocarditis; persistent bacteremia; evidence of endocardial involvement with positive echocardiogram with signs of oscillating vegetation, abscesses, valve perforation, new partial dehiscence of prosthetic valve or new valvular regurgitation. Minor criteria include predisposing heart condition, fever, vascular phenomena, immunologic phenomena, \\& positive blood culture or echocardiogram not meeting major criteria.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Endocarditis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Using Duke Criteria, endocarditis can be confirmed by:\n\nPathological criteria: Endocarditis is confirmed if microorganisms are identified by culture or histology in a vegetation, embolized vegetation, or an intracardiac abscess; or if pathological lesions are observed \\& histologically confirmed showing active endocarditis.\n\nClinical criteria: Endocarditis is confirmed by the presence of 2 major criteria, 1 major plus 3 minor criteria, or 5 minor criteria.\n\nMajor criteria include persistently +ve blood cultures with the presence of typical organisms for endocarditis; persistent bacteremia; evidence of endocardial involvement with positive echocardiogram with signs of oscillating vegetation, abscesses, valve perforation, new partial dehiscence of prosthetic valve or new valvular regurgitation.\n\nMinor criteria include predisposing heart condition, fever, vascular phenomena, immunologic phenomena, \\& positive blood culture or echocardiogram not meeting major criteria.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Atrial Septal Defect (ASD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.\n\n.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Occurrence of clinically significant ASD as a result of the procedure requiring intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Atrial Septal Defect (ASD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Occurrence of clinically significant ASD as a result of the procedure requiring intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Mitral Valve Stenosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of total 78 participants, only 72 participants were analyzed as 6 deaths within 30 days.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Mitral Valve Stenosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of total 78 participants, only 72 participants were analyzed because 3 patients were not implanted with a device and 3 patients died prior to discharge.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Mitral Valve Stenosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months', 'description': 'Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Mitral Valve Stenosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 months', 'description': 'Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Mitral Valve Stenosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 months', 'description': 'Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mitral Valve Area: By Planimetry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '0.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Mitral valve area as measured by core lab echocardiography.', 'unitOfMeasure': 'cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 78 total population, 50 participants were included in analysis population because of 6 deaths and Mitral Valve Area by planimetry was not done in 22 patients.'}, {'type': 'SECONDARY', 'title': 'Mitral Valve Area: By Planimetry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Mitral valve area as measured by core lab echocardiography.', 'unitOfMeasure': 'cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 78 total population, 45 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 11 patients Mitral valve area evaluation was not done or un-evaluable.'}, {'type': 'SECONDARY', 'title': 'Mitral Valve Area: By Planimetry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '0.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'Mitral valve area as measured by core lab echocardiography.', 'unitOfMeasure': 'cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 78 total population, 19 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 25 patients Mitral valve area evaluation was not done or un-evaluable.'}, {'type': 'SECONDARY', 'title': 'Mitral Valve Area: By Planimetry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '0.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36 months', 'description': 'Mitral valve area as measured by core lab echocardiography.', 'unitOfMeasure': 'cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 78 total population, 25 participants were included in analysis population because of 31 deaths within 3 years, 7 withdrawals, 1 missed visit and in 14 patients mitral valve area evaluation was not done or un-evaluable.'}, {'type': 'SECONDARY', 'title': 'Mitral Valve Area: By Planimetry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 months', 'description': 'Mitral valve area as measured by core lab echocardiography.', 'unitOfMeasure': 'cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 78 total population, 18 participants were included in analysis population because of 33 deaths within 4 years, 8 withdrawals, 3 missed visit and in 16 patients Mitral Valve Area evaluation was not done or un-evaluable.'}, {'type': 'SECONDARY', 'title': 'Mitral Valve Area: By Planimetry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '0.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 months', 'description': 'Mitral valve area as measured by core lab echocardiography.', 'unitOfMeasure': 'cm^2', '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': 'Mitral Valve Area: By Pressure Half-time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '1.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Mitral valve area as measured by core lab echocardiography.', 'unitOfMeasure': 'cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 78 total population, 66 participants were included in analysis population because of 6 deaths and in 6 patients Mitral valve area evaluation was not done or un-evaluable.'}, {'type': 'SECONDARY', 'title': 'Mitral Valve Area: By Pressure Half-time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. 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The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '0.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Mitral valve area as measured by core lab echocardiography and indexed to body surface area \\[MVA Index = MVA (cm\\^2)/BSA (m\\^2)\\]', 'unitOfMeasure': 'cm^2/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 78 total population, 45 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 11 patients Mitral valve index evaluation was not done or un-evaluable.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With New Coumadin Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'New onset use of Coumadin or warfarin to treat a potential thrombus on a defibrillator lead.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '49 patients not on coumadin at baseline are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With New Coumadin Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'New onset use of Coumadin or warfarin to treat a potential thrombus on a defibrillator lead.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '49 patients not on coumadin at baseline are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With New Coumadin Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'New onset use of Coumadin or warfarin to treat a potential thrombus on a defibrillator lead.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '49 patients not on coumadin at baseline are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Discharged to a Nursing Home or Skilled Nursing Facility or Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 Days', 'description': 'Discharge to a nursing home or skilled nursing facility following discharge from the hospital after definitive treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Post-procedure Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '6.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Length of Hospital Stay, assessed at 30 days', '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'}, {'type': 'SECONDARY', 'title': 'Post-procedure Intensive Care Unit (ICU)/ Critical Care Unit (CCU) Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.3', 'spread': '80.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Length of ICU/CCU stay, assessed at 30 Days', 'description': 'Number of hours 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'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Successful Clip Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 Days', 'description': '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'}, {'type': 'SECONDARY', 'title': 'Number of Participants With High Risk Procedural Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With MR Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'title': '0 : None', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '1+: Mild', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': '2+: Moderate', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': '3+: Moderate to Severe', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': '4+: Severe', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Discharge or 30 days', 'description': 'MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 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': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'title': '0+: None', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '1+: Mild', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': '2+: Moderate', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': '3+: Moderate to Severe', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': '4+: Severe', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and MR Severity not done or un-evaluable in 2 patients.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With MR Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'title': '0+: None', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '1+: Mild', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': '2+: Moderate', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': '3+: Moderate to Severe', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': '4+: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months', 'description': 'MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 78 total population, 42 participants were included in the analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and MR severity not assessed in 2 patients.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With MR Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'title': '0+: None', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '1+: Mild', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': '2+: Moderate', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': '3+: Moderate to Severe', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': '4+: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 months', 'description': 'MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 78 total population, 37 participants were included in the analysis population because of 31 deaths within 3 years, 7 withdrawals, 1 missed visit and MR Severity was not done or un-evaluable in 2 patients.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With MR Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'title': '0+: None', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '1+: Mild', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': '2+: Moderate', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': '3+: Moderate to Severe', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': '4+: Severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 months', 'description': 'MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 78 total population, 31 participants were included in the analysis population because of 33 deaths within 3 years, 8 withdrawals, 3 missed visit and MR severity was not done or un-evaluable in 3 patients.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With MR Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'title': '0+: None', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '1+: Mild', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': '2+: Moderate', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': '3+: Moderate to Severe', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': '4+: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 months', 'description': 'MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 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 Treatment Durability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Defined as the proportion of Acute Procedural Success patients with MR severity grade of 2+ or less that have not required surgery for valve dysfunction.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 78 total population, 56 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals and 1 missed visit.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Durability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months', 'description': 'Defined as the proportion of Acute Procedural Success patients with MR severity grade of 2+ or less that have not required surgery for valve dysfunction.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'At 24 months, of the 56 patients who achieved acute procedural success, the status of 3 patients is unknown. Among the remaining 53 patients, 30 patients (56.6%) were alive and free from MR \\> 2+ at 24 months.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Durability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that 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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 62 patients with an acute reduction in MR severity of at least one grade, and of these, 43 patients met the criterion for clinical durability. The clinical durability rate is therefore 43/62, or 69.4%.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Durability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months', 'description': 'Proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that 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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Through 24 months, the clinical durability status of 3 patients is unknown and there were 35 patients with an acute reduction in MR severity from baseline of at least one grade (the one patient who underwent surgery between 12 months and 24 months is not included in the 35 patients).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'title': 'NYHA Functional Class I', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'NYHA Functional Class II', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'NYHA Functional Class III', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'NYHA Functional Class IV', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months', 'description': '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': 'Of 78 total population, 43 participants were included in the analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and 1 patient without NYHA Class assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'title': 'NYHA Functional Class I', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'NYHA Functional Class II', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'NYHA Functional Class III', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'NYHA Functional Class IV', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 months', 'description': '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': 'Of 78 total population, 37 participants were included in analysis population because of 31 deaths within 3 years, 7 withdrawals, 1 missed visit and 2 patients without NYHA Class assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'title': 'NYHA Functional Class I', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'NYHA Functional Class II', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'NYHA Functional Class III', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'NYHA Functional Class IV', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 months', 'description': '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': 'Of 78 total population, 31 participants were included in the analysis population because of 33 deaths within 3 years, 8 withdrawals, 3 missed visit and NYHA was not assessed in 3 patients.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With New York Heart Association (NYHA) Class', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'title': 'NYHA Functional Class I', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'NYHA Functional Class II', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'NYHA Functional Class III', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'NYHA Functional Class IV', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 months', 'description': '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': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '136.3', 'spread': '37.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 78 total population, 39 participants were included in the analysis population because of 26 deaths within 2 year, 7 withdrawals, 1 missed visit and LVEDV was not done or un-evaluable in 5 patients.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular End-diastolic Volume (LVEDV).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '135.7', 'spread': '40.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36 months', 'description': 'Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).', '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': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '139.5', 'spread': '46.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 months', 'description': 'Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).', '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': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '133.5', 'spread': '48.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 months', 'description': 'Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).', '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': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '71.3', 'spread': '33.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 78 total population, 39 participants were included in the analysis population because of 26 deaths within 2 year, 7 withdrawals, 1 missed visit and LVESV was not done or un-evaluable in 5 patients.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular End-systolic Volume (LVESV).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.4', 'spread': '33.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36 months', 'description': 'Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).', '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': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '73.3', 'spread': '36.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 months', 'description': 'Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).', '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': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.2', 'spread': '38', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 months', 'description': 'Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).', '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 Measurement: Left Ventricular Internal Dimension Diastole (LVIDd), Left Ventricular Internal Dimension Systole (LVIDs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'title': 'LV Internal Diameter, Diastole (LVIDd)', 'categories': [{'measurements': [{'value': '5.3', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'LV Internal Diameter, Systole (LVIDs)', 'categories': [{'measurements': [{'value': '4.0', 'spread': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 78 total population, 42 participants were included in the analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and LVIDd/LVIDs not done or un-evaluable in 2 patients.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Measurement: Left Ventricular Internal Dimension Diastole (LVIDd), Left Ventricular Internal Dimension Systole (LVIDs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'title': 'LV Internal Diameter, Diastole (LVIDd)', 'categories': [{'measurements': [{'value': '5.4', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'LV Internal Diameter, Systole (LVIDs)', 'categories': [{'measurements': [{'value': '4.1', 'spread': '1.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36 months', 'description': 'Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).', '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 Measurement: Left Ventricular Internal Dimension Diastole (LVIDd), Left Ventricular Internal Dimension Systole (LVIDs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'title': 'LV Internal Diameter, Diastole (LVIDd)', 'categories': [{'measurements': [{'value': '5.5', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'LV Internal Diameter, Systole (LVIDs)', 'categories': [{'measurements': [{'value': '4.0', 'spread': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 months', 'description': 'Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).', '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 Measurement: Left Ventricular Internal Dimension Diastole (LVIDd), Left Ventricular Internal Dimension Systole (LVIDs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'title': 'LV Internal Diameter, Diastole (LVIDd)', 'categories': [{'measurements': [{'value': '5.5', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'LV Internal Diameter, Systole (LVIDs)', 'categories': [{'measurements': [{'value': '4.2', 'spread': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 months', 'description': 'Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).', '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': 'Number of Days Re-hospitalized for CHF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'spread': '3.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Defined as the number of days hospitalized for CHF in the 12-months prior to the Clip implant procedure date compared to the number of days re-hospitalized for CHF in the 12-months after Clip implant.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '12/75 hospitalized for CHF post-discharge, representing 22 separate hospitalization events with mean of 6.6+/-3.7 days.'}, {'type': 'SECONDARY', 'title': 'Number of Hospital Re-Admissions for Congestive Heart Failure (CHF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Defined as the number of hospital admissions (i.e. events) for which the primary diagnosis for hospitalization is congestive heart failure, in the 12-months post-discharge following the MitraClip procedure.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 78 patients, 3 patients who died prior to discharge were not included.'}, {'type': 'SECONDARY', 'title': 'Regurgitant Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.2', 'spread': '14.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Regurgitant volume as measured by the core echocardiographic laboratory at follow-up.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 78 total population, 58 participants were included in the analysis population because of 6 deaths within 30 days and 14 missing data (not done or not evaluable).'}, {'type': 'SECONDARY', 'title': 'Regurgitant Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.4', 'spread': '15.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Regurgitant volume as measured by the core echocardiographic laboratory at follow-up.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 78 total population, 44 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 6 patients Regurgitant volume evaluation was not done or not evaluable.'}, {'type': 'SECONDARY', 'title': 'Regurgitant Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.9', 'spread': '10.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'Regurgitant volume as measured by the core echocardiographic laboratory at follow-up.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 78 total population, 26 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and 18 patients were without Regurgitant Volume assessment.'}, {'type': 'SECONDARY', 'title': 'Regurgitant Fraction (RF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.1', 'spread': '15.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'RF is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.', 'unitOfMeasure': 'percentage of LV stroke volume', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 78 total population, 58 participants were analysed as 6 participants died within 30 days and 14 missing data (not done or not evaluable).'}, {'type': 'SECONDARY', 'title': 'Regurgitant Fraction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.3', 'spread': '16.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'RF is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.', 'unitOfMeasure': 'percentage of LV stroke volume', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 78 total population, 44 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 6 patients Regurgitant fraction evaluation was not done or not evaluable.'}, {'type': 'SECONDARY', 'title': 'Regurgitant Fraction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.4', 'spread': '13.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'RF is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.', 'unitOfMeasure': 'percentage of LV stroke volume', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 78 total population, 26 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and 18 patients were without Regurgitant fraction assessment.'}, {'type': 'SECONDARY', 'title': 'Cardiac Output (CO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '1.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 Days', 'description': 'CO is defined as the volume of blood pumped by the left ventricle per unit time (L/min).', 'unitOfMeasure': 'l/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 78 total population, 66 participants were included in analysis population because of 6 deaths within 30 days and in 6 patients Cardiac Output was not assessed or or un-evaluable.'}, {'type': 'SECONDARY', 'title': 'Cardiac Output', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'CO is defined as the volume of blood pumped by the left ventricle per unit time (L/min)', 'unitOfMeasure': 'l/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 78 total population, 53 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 3 patients Cardiac output evaluation was not done or un-evaluable.'}, {'type': 'SECONDARY', 'title': 'Cardiac Output', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '0.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'CO is defined as the volume of blood pumped by the left ventricle per unit time (L/min)', 'unitOfMeasure': 'l/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 78 total population, 40 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 4 patients Cardiac output evaluation was not done or un-evaluable.'}, {'type': 'SECONDARY', 'title': 'Cardiac Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'spread': '0.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 Days', 'description': 'Cardiac index (cardiac output divided by body surface area) as measured by core lab echocardiography.', 'unitOfMeasure': 'l/min/m2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 78 total population, 66 participants were included in the analysis population because of 6 deaths within 30 days and in 6 participants cardiac Index was un-evaluable or not done.'}, {'type': 'SECONDARY', 'title': 'Cardiac Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'spread': '0.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Cardiac index (cardiac output divided by body surface area) as measured by core lab echocardiography.', 'unitOfMeasure': 'l/min/m2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 78 total population, 53 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 3 patients Cardiac Index evaluation was not done or un-evaluable.'}, {'type': 'SECONDARY', 'title': 'Cardiac Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '0.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'Cardiac index (cardiac output divided by body surface area) as measured by core lab echocardiography.', 'unitOfMeasure': 'l/min/m2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 78 total population, 40 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 4 patients cardiac index evaluation was not done or un-evaluable.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Ejection Fraction (LVEF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.3', 'spread': '12.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Discharge or 30 days', 'description': 'Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography 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': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.2', 'spread': '13.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography 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': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.5', 'spread': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography 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': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.5', 'spread': '12.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36 months', 'description': 'Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography 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': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.9', 'spread': '12.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 months', 'description': 'Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography 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': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.5', 'spread': '13.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 months', 'description': 'Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography 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': 'Percentage of Participants With Freedom From Mitral Valve Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Freedom From Mitral Valve Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes 58 participants, which represents the number of patients at risk as per Kaplan-Meier freedom from Mitral valve (MV)surgery analysis at 12 months.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Freedom From Mitral Valve Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes 45 participants, which represents the number of patients at risk as per Kaplan-Meier analysis at 24 months.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Freedom From Mitral Valve Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '36 months', 'description': 'Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes 39 participants, which represents the number of patients at risk as per Kaplan-Meier analysis at 36 months.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Freedom From Mitral Valve Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 months', 'description': 'Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes 35 participants, which represents the number of patients at risk as per Kaplan-Meier analysis at 48 months.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Freedom From Mitral Valve Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '60 months', 'description': 'Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes 14 participants, which represents the number of patients at risk as per Kaplan-Meier analysis at 60 months.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Mitral Valve Repair Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Mitral Valve Repair Success defined as freedom from mitral valve replacement surgery for valve dysfunction, death, re-operation and MR \\> 2+ at 12 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Mitral Valve Repair Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months', 'description': 'Freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR \\> 2+.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Three Acute Procedural Success (APS) patients withdrew at or before 12 months, and had MR ≤ 2+ at all visits prior to withdrawal. Since there is no data on these patients post-12 months, these patients are not included in the endpoint of freedom from mitral valve replacement surgery for Valve Dysfunction, death and MR \\> 2+ at 24 months.'}, {'type': 'SECONDARY', 'title': 'Composite Functional and Structural Measures - Percentage of Participants With Freedom From Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '64.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint. Death is further divided into 2 categories:\n\nA. Cardiac death is defined as death due to any of the following:\n\n1. Acute myocardial infarction.\n2. Cardiac perforation/pericardial tamponade.\n3. Arrhythmia or conduction abnormality.\n4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure.\n5. Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.\n6. Any death for which a cardiac cause cannot be excluded.\n\nB. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes 46 participants, which represents the number of patients at risk as per Kaplan-Meier freedom from mortality analysis at 24 months.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Composite Functional and Structural Measures - Freedom From Death and MR >2+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'title': 'Primary Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '49.3', 'groupId': 'OG000', 'lowerLimit': '37.6', 'upperLimit': '61.1'}]}]}, {'title': 'Worstcase Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.2', 'groupId': 'OG000', 'lowerLimit': '34.8', 'upperLimit': '57.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'Kaplan-Meier estimated proportion of patients who are alive and have a mitral regurgitation severity grade of 2+ or less.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis at 24 months included only 75 patients. Three patients were excluded due to withdrawal at or before 12 months.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Device Embolization or Single Leaflet Device Attachment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'title': 'Device Embolization', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Single Leaflet Device Attachment', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 12 months', 'description': 'Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.\n\nA single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Three patients were excluded from the analysis as they did not receive a Device.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Device Embolization or Single Leaflet Device Attachment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'title': 'Device Embolization', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Single Leaflet Device Attachment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months', 'description': 'Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.\n\nA single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients implanted with a MitraClip device, alive were evaluated at 24 months.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Device Embolization or Single Leaflet Device Attachment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'title': 'Device Embolization', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Single Leaflet Device Attachment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 months', 'description': 'Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.\n\nA single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients implanted with a MitraClip device and alive were evaluated at 48 months.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Device Embolization or Single Leaflet Device Attachment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'title': 'Device Embolization', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Single Leaflet Device Attachment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 months', 'description': 'Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.\n\nA single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients implanted with a MitraClip device, alive were evaluated at 36 months.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Device Embolization or Single Leaflet Device Attachment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'title': 'Device Embolization', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Single Leaflet Device Attachment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 months', 'description': 'Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.\n\nA single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients implanted with a MitraClip device and alive were evaluated at 60 months.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Mitral Valve Surgery Post-MitraClip Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 months', 'description': 'Number of patients who underwent surgical mitral valve repair or replacement after the index MitraClip procedure.', '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 MitraClip Device Implanted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 5 years', 'description': 'It is a summary of re-interventions to place an additional MitraClip Device.', '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': 'Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '36 months', 'description': 'Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 months', 'description': 'Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '60 months', 'description': 'Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure', 'unitOfMeasure': 'percentage of 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 Valve Replacement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Defined as how often patients receiving surgery required replacement of the mitral valve.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Mitral Valve Replacement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months', 'description': 'Defined as how often patients receiving surgery required replacement of the mitral valve.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Mitral Valve Replacement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 months', 'description': 'Defined as how often patients receiving surgery required replacement of the mitral valve.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Mitral Valve Replacement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 months', 'description': 'Defined as how often patients receiving surgery required replacement of the mitral valve.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The 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': '78'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}]}], 'recruitmentDetails': 'Patients who met eligibility criteria for the study and had a MitraClip procedure, whether a Device was implanted or not, were considered enrolled in the Registry. A total of 78 patients were enrolled at 35 North American sites. Screening period: Jan, 2007-2008. Enrollment period: Feb 14, 2007- Jan 30, 2008.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '76.7', 'spread': '9.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '18-75 years', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}, {'title': '>75 years', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '49', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Predicted Surgical Mortality', 'classes': [{'categories': [{'measurements': [{'value': '18.2', 'spread': '8.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "The Society of Thoracic Surgeons' risk models predict the risk of operative mortality \\& morbidity after adult cardiac surgery.\n\nRisk models were developed for nine specific endpoints, including operative mortality.Operative mortality includes both (1) all deaths occurring during the hospitalization, even if after 30 days (2) deaths occurring after discharge, but within 30 days of the procedure.\n\nTherefore, a patient's mortality risk score is defined as the patient's predicted risk of operative mortality as calculated by the specific operative mortality statistical model.", 'unitOfMeasure': 'Probability percentage', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'LV Measurement', 'classes': [{'title': 'Left Ventricular End Diastolic Volume (LVEDV)', 'categories': [{'measurements': [{'value': '166.5', 'spread': '50.7', 'groupId': 'BG000'}]}]}, {'title': 'Left Ventricular End Systolic Volume (LVESV)', 'categories': [{'measurements': [{'value': '79.9', 'spread': '42.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'LV Measurement', 'classes': [{'title': 'Left Ventricular Internal Diameter Diastole(LVIDd)', 'categories': [{'measurements': [{'value': '5.6', 'spread': '0.7', 'groupId': 'BG000'}]}]}, {'title': 'Left Ventricular Internal Diameter Systole (LVIDs)', 'categories': [{'measurements': [{'value': '3.9', 'spread': '1.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '36-Item Short Form Health Survey (SF-36) Quality of Life', 'classes': [{'title': 'Physical Health (PCS)', 'categories': [{'measurements': [{'value': '31.6', 'spread': '9.1', 'groupId': 'BG000'}]}]}, {'title': 'Mental Health (MCS)', 'categories': [{'measurements': [{'value': '44.2', 'spread': '12.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', '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: physical functioning, role limitations due to physical or emotional health, bodily pain, general health perceptions, vitality, social functioning, \\& general mental health. Higher scores represent better self-perceived health. The PCS \\& MCS norms for 65-75 year olds are 44 and 52, while the norms for CHF population are 31 and 46, respectively.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'NYHA Functional Class', 'classes': [{'title': 'NYHA Functional Class I', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'NYHA Functional Class II', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'NYHA Functional Class III', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}]}]}, {'title': 'NYHA Functional Class IV', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': '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.\n\nClass III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.\n\nClass IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or anginal syndrome may be present even at rest \\& discomfort is increased with physical activity.', 'unitOfMeasure': 'participants'}, {'title': 'Number of patients hospitalized for CHF during 12 months before enrollment', 'classes': [{'title': 'Number of patients hospitalized for CHF', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}, {'title': 'Number of patients not hospitalized for CHF', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of CHF events leading to hospitalizations during 12 months before enrollment', 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'events'}, {'title': 'Number of hospitalization days for CHF at 12 months before enrollment', 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'spread': '4.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'dispFirstSubmitDate': '2013-09-18', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-05', 'studyFirstSubmitDate': '2013-09-03', 'dispFirstSubmitQcDate': '2013-09-18', 'resultsFirstSubmitDate': '2013-12-10', 'studyFirstSubmitQcDate': '2013-09-11', 'dispFirstPostDateStruct': {'date': '2013-09-23', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-11-21', 'studyFirstPostDateStruct': {'date': '2013-09-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite Functional and Structural Measures - Freedom From Death', 'timeFrame': '12 months', 'description': 'Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint. Death is further divided into 2 categories:\n\nA. Cardiac death is defined as death due to any of the following:\n\n1. Acute myocardial infarction.\n2. Cardiac perforation/pericardial tamponade.\n3. Arrhythmia or conduction abnormality.\n4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure.\n5. Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.\n6. Any death for which a cardiac cause cannot be excluded.\n\nB. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).'}, {'measure': 'Percentage of Participants With Freedom From Death and Mitral Regurgitation (MR) >2+', 'timeFrame': '12 months', 'description': 'Kaplan-Meier estimated percentage of patients who are alive and have a mitral regurgitation severity grade of 2+ or less'}, {'measure': 'Number of Participants With Clinical Measures of Benefit-New York Heart Association (NYHA) Class', 'timeFrame': '30 days', 'description': 'The major effectiveness endpoint is an assessment of multiple functional and structural measures of benefit including New York Heart Association (NYHA) Class.\n\nClass 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 New York Heart Association (NYHA) Class', 'timeFrame': '12 months', 'description': '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': 'Clinical Measures of Benefit-Quality of Life (QOL) as Measured by Short Form (SF) 36', 'timeFrame': '12 months', 'description': 'Standardized quality of life surveys allow physicians to evaluate the effectiveness of different treatment methods and the physical and psychological benefits a patient is likely to receive from a particular treatment.In the EVEREST II HRR,the patients were asked to complete the SF-36 QOL survey at baseline, 30 days and 12 months. The physical \\& mental function were assessed by the Physical Component Summary (PCS) score \\& Mental Component Summary (MCS) score. The PCS \\& MCS norms for 65-75 year olds are 44 and 52 respectively; and 31 \\& 46 for congestive heart failure (CHF) patients respectively. Each scale from the SF-36 is an algebraic sum of responses for all items in that scale.For ease of analysis each scale is then transformed to a 0-100 scale using a formula that converts the lowest \\& highest possible scores to 0 \\& 100 respectively.The scoring of the SF-36 indicates that 0% in a domain represents the poorest possible QoL \\& 100% indicates full QoL.'}, {'measure': 'Left Ventricular End Diastolic Volume (LVEDV)', 'timeFrame': '12 months', 'description': 'Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).'}, {'measure': 'Left Ventricular End Systolic Volume (LVESV)', 'timeFrame': '12 months', 'description': 'Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).'}, {'measure': 'Left Ventricular (LV) Function - Internal Dimension', 'timeFrame': '12 months', 'description': 'Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).'}, {'measure': 'Number of Patients With CHF Having Hospitalization During Discharge Through 12 Months', 'timeFrame': '12 months', 'description': 'Number of patients with incidence of re-hospitalizations for CHF in the 12-months after the MitraClip implant procedure.'}, {'measure': 'Number of CHF Events Leading to Hospitalizations During Discharge Through 12 Months', 'timeFrame': '12 months', 'description': 'Incidence of re-hospitalizations for CHF in the 12-months after the MitraClip implant procedure.'}, {'measure': 'Left Ventricular End Diastolic Volume (LVEDV)', 'timeFrame': 'Discharge or 30 days', 'description': 'Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).'}, {'measure': 'Left Ventricular End Systolic Volume (LVESV)', 'timeFrame': 'Discharge or 30 days', 'description': 'Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).'}, {'measure': 'Left Ventricular (LV) Function - Internal Dimension', 'timeFrame': 'Discharge or 30 days', 'description': 'Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Experiencing Major Adverse Events (MAE)', 'timeFrame': '30 days', 'description': 'Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective 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 Experiencing Major Adverse Events', 'timeFrame': '12 months', 'description': 'Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective 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': 'Procedural Freedom From In-hospital MAE', 'timeFrame': '30 Days', 'description': 'Percutaneous Clip procedure or surgery with no occurrence of in-hospital MAE.'}, {'measure': 'Number of Participants Over 75 Years of Age With MAE', 'timeFrame': '30 days', 'description': 'Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective 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 Over 75 Years of Age With MAE', 'timeFrame': '12 months', 'description': 'Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective 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 Experiencing Major Vascular Complications', 'timeFrame': '30 days', 'description': 'Defined as the occurrence of any of the following resulting from the index procedure:\n\n* Hematoma at access site \\>6 cm;\n* Retroperitoneal hematoma;\n* Arterial-venous fistula;\n* Symptomatic peripheral ischemia/ nerve injury with clinical signs or symptoms lasting \\>24 hours;\n* Vascular surgical repair at catheter access sites;\n* Pulmonary embolism;\n* Ipsilateral deep vein thrombus; or\n* Access site-related infection requiring intravenous antibiotics and/or extended hospitalization.'}, {'measure': 'Number of Participants Experiencing Major Vascular Complications', 'timeFrame': '12 months', 'description': 'Defined as the occurrence of any of the following resulting from the index procedure:\n\n* Hematoma at access site \\>6 cm;\n* Retroperitoneal hematoma;\n* Arterial-venous fistula;\n* Symptomatic peripheral ischemia/ nerve injury with clinical signs or symptoms lasting \\>24 hours;\n* Vascular surgical repair at catheter access sites;\n* Pulmonary embolism;\n* Ipsilateral deep vein thrombus; or\n* Access site-related infection requiring intravenous antibiotics and/or extended hospitalization.'}, {'measure': 'Number of Participants With Major Bleeding Complications', 'timeFrame': '30 days', 'description': 'Defined as procedure related bleeding that requires a transfusion of ≥2 units of blood and/or surgical intervention.'}, {'measure': 'Number of Participants With Major Bleeding Complications', 'timeFrame': '12 months', 'description': 'Defined as procedure related bleeding that requires a transfusion of ≥2 units of blood and/or surgical intervention.'}, {'measure': 'Number of Participants With Non-cerebral Thromboembolism', 'timeFrame': '30 days', 'description': 'Defined as any mural thrombus or thromboembolism in the vasculature (excluding central nervous system events) confirmed by standard clinical and laboratory testing and which requires intervention.'}, {'measure': 'Number of Participants With Non-cerebral Thromboembolism', 'timeFrame': '12 months', 'description': 'Defined as any mural thrombus or thromboembolism in the vasculature (excluding central nervous system events) confirmed by standard clinical and laboratory testing and which requires intervention.'}, {'measure': 'Number of Participants With Thrombosis', 'timeFrame': '30 days', 'description': 'Evidence of formation of an independently moving thrombus on any part of the Clip or any commercially available implant used during surgery by echocardiography or fluoroscopy. If Clip is explanted or an autopsy is performed this diagnosis should be confirmed.'}, {'measure': 'Number of Participants With Thrombosis', 'timeFrame': '12 months', 'description': 'Evidence of formation of an independently moving thrombus on any part of the Clip or any commercially available implant used during surgery by echocardiography or fluoroscopy. If Clip is explanted or an autopsy is performed this diagnosis should be confirmed.'}, {'measure': 'Number of Participants With Hemolysis', 'timeFrame': '30 days', 'description': 'Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on two measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms'}, {'measure': 'Number of Participants With Hemolysis', 'timeFrame': '12 months', 'description': 'Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on two measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms.'}, {'measure': 'Number of Participants With Dysrhythmias', 'timeFrame': '30 days', 'description': 'Includes all new onset atrial fibrillation and heart block requiring placement of a permanent pacemaker.'}, {'measure': 'Number of Participants With Dysrhythmias', 'timeFrame': '12 months', 'description': 'Includes all new onset atrial fibrillation and heart block requiring placement of a permanent pacemaker.'}, {'measure': 'Number of Participants With Endocarditis', 'timeFrame': '30 days', 'description': 'Using Duke Criteria, endocarditis can be confirmed by:\n\nPathological criteria: Endocarditis is confirmed if microorganisms are identified by culture or histology in a vegetation, embolized vegetation, or an intracardiac abscess; or if pathological lesions are observed \\& histologically confirmed showing active endocarditis.\n\nClinical criteria: Endocarditis is confirmed by the presence of 2 major criteria, 1 major plus 3 minor criteria, or 5 minor criteria. Major criteria include persistently +ve blood cultures with the presence of typical organisms for endocarditis; persistent bacteremia; evidence of endocardial involvement with positive echocardiogram with signs of oscillating vegetation, abscesses, valve perforation, new partial dehiscence of prosthetic valve or new valvular regurgitation. Minor criteria include predisposing heart condition, fever, vascular phenomena, immunologic phenomena, \\& positive blood culture or echocardiogram not meeting major criteria.'}, {'measure': 'Number of Participants With Endocarditis', 'timeFrame': '12 months', 'description': 'Using Duke Criteria, endocarditis can be confirmed by:\n\nPathological criteria: Endocarditis is confirmed if microorganisms are identified by culture or histology in a vegetation, embolized vegetation, or an intracardiac abscess; or if pathological lesions are observed \\& histologically confirmed showing active endocarditis.\n\nClinical criteria: Endocarditis is confirmed by the presence of 2 major criteria, 1 major plus 3 minor criteria, or 5 minor criteria.\n\nMajor criteria include persistently +ve blood cultures with the presence of typical organisms for endocarditis; persistent bacteremia; evidence of endocardial involvement with positive echocardiogram with signs of oscillating vegetation, abscesses, valve perforation, new partial dehiscence of prosthetic valve or new valvular regurgitation.\n\nMinor criteria include predisposing heart condition, fever, vascular phenomena, immunologic phenomena, \\& positive blood culture or echocardiogram not meeting major criteria.'}, {'measure': 'Number of Participants With Atrial Septal Defect (ASD)', 'timeFrame': '30 days', 'description': 'Occurrence of clinically significant ASD as a result of the procedure requiring intervention.'}, {'measure': 'Number of Participants With Atrial Septal Defect (ASD)', 'timeFrame': '12 months', 'description': 'Occurrence of clinically significant ASD as a result of the procedure requiring intervention.'}, {'measure': 'Number of Participants With Mitral Valve Stenosis', 'timeFrame': '30 days', 'description': 'Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.'}, {'measure': 'Number of Participants With Mitral Valve Stenosis', 'timeFrame': '12 months', 'description': 'Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.'}, {'measure': 'Number of Participants With Mitral Valve Stenosis', 'timeFrame': '24 months', 'description': 'Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.'}, {'measure': 'Number of Participants With Mitral Valve Stenosis', 'timeFrame': '36 months', 'description': 'Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.'}, {'measure': 'Number of Participants With Mitral Valve Stenosis', 'timeFrame': '48 months', 'description': 'Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.'}, {'measure': 'Mitral Valve Area: By Planimetry', 'timeFrame': '30 days', 'description': 'Mitral valve area as measured by core lab echocardiography.'}, {'measure': 'Mitral Valve Area: By Planimetry', 'timeFrame': '12 months', 'description': 'Mitral valve area as measured by core lab echocardiography.'}, {'measure': 'Mitral Valve Area: By Planimetry', 'timeFrame': '24 months', 'description': 'Mitral valve area as measured by core lab echocardiography.'}, {'measure': 'Mitral Valve Area: By Planimetry', 'timeFrame': '36 months', 'description': 'Mitral valve area as measured by core lab echocardiography.'}, {'measure': 'Mitral Valve Area: By Planimetry', 'timeFrame': '48 months', 'description': 'Mitral valve area as measured by core lab echocardiography.'}, {'measure': 'Mitral Valve Area: By Planimetry', 'timeFrame': '60 months', 'description': 'Mitral valve area as measured by core lab echocardiography.'}, {'measure': 'Mitral Valve Area: By Pressure Half-time', 'timeFrame': '30 days', 'description': 'Mitral valve area as measured by core lab echocardiography.'}, {'measure': 'Mitral Valve Area: By Pressure Half-time', 'timeFrame': '12 months', 'description': 'Mitral valve area as measured by core lab echocardiography.'}, {'measure': 'Mitral Valve Area: By Pressure Half-time', 'timeFrame': '24 months', 'description': 'Mitral valve area as measured by core lab echocardiography.'}, {'measure': 'Mitral Valve Area: By Pressure Half-time', 'timeFrame': '36 months', 'description': 'Mitral valve area as measured by core lab echocardiography.'}, {'measure': 'Mitral Valve Area: By Pressure Half-time', 'timeFrame': '48 months', 'description': 'Mitral valve area as measured by core lab echocardiography.'}, {'measure': 'Mitral Valve Area: By Pressure Half-time', 'timeFrame': '60 months', 'description': 'Mitral valve area as measured by core lab echocardiography.'}, {'measure': 'Mitral Valve Area Index : By Planimetry', 'timeFrame': '30 days', 'description': 'Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area \\[MVA Index = MVA (cm\\^2)/BSA (m\\^2)\\].'}, {'measure': 'Mitral Valve Area Index : By Planimetry', 'timeFrame': '12 months', 'description': 'Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area \\[MVA Index = MVA (cm\\^2)/BSA (m\\^2)\\].'}, {'measure': 'Mitral Valve Area Index : By Planimetry', 'timeFrame': '24 months', 'description': 'Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area \\[MVA Index = MVA (cm\\^2)/BSA (m\\^2)\\].'}, {'measure': 'Mitral Valve Area Index : By Planimetry', 'timeFrame': '36 months', 'description': 'Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area \\[MVA Index = MVA (cm\\^2)/BSA (m\\^2)\\].'}, {'measure': 'Mitral Valve Area Index : By Planimetry', 'timeFrame': '48 months', 'description': 'Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area \\[MVA Index = MVA (cm\\^2)/BSA (m\\^2)\\].'}, {'measure': 'Mitral Valve Area Index : By Planimetry', 'timeFrame': '60 months', 'description': 'Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area \\[MVA Index = MVA (cm\\^2)/BSA (m\\^2)\\].'}, {'measure': 'Mitral Valve Area (MVA) Index: by Pressure-Half Time Formula', 'timeFrame': '30 days', 'description': 'Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to Body surface area (BSA).\n\n\\[MVA Index = MVA (cm\\^2)/BSA (m\\^2)\\]'}, {'measure': 'Mitral Valve Area Index : By Pressure Half-time Formula', 'timeFrame': '12 months', 'description': 'Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area \\[MVA Index = MVA (cm\\^2)/BSA (m\\^2)\\].'}, {'measure': 'Mitral Valve Area Index : By Pressure Half-time Formula', 'timeFrame': '24 months', 'description': 'Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area \\[MVA Index = MVA (cm\\^2)/BSA (m\\^2)\\].'}, {'measure': 'Mitral Valve Area Index : By Pressure Half-time Formula', 'timeFrame': '36 months', 'description': 'Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area \\[MVA Index = MVA (cm\\^2)/BSA (m\\^2)\\].'}, {'measure': 'Mitral Valve Area Index : By Pressure Half-time Formula', 'timeFrame': '48 months', 'description': 'Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area \\[MVA Index = MVA (cm\\^2)/BSA (m\\^2)\\].'}, {'measure': 'Mitral Valve Area Index : By Pressure Half-time Formula', 'timeFrame': '60 months', 'description': 'Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area \\[MVA Index = MVA (cm\\^2)/BSA (m\\^2)\\].'}, {'measure': 'Transvalvular Mitral Valve Gradient', 'timeFrame': '30 days', 'description': 'Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.'}, {'measure': 'Transvalvular Mitral Valve Gradient', 'timeFrame': '12 months', 'description': 'Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.'}, {'measure': 'Transvalvular Mitral Valve Gradient', 'timeFrame': '24 months', 'description': 'Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.'}, {'measure': 'Transvalvular Mitral Valve Gradient', 'timeFrame': '36 months', 'description': 'Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.'}, {'measure': 'Transvalvular Mitral Valve Gradient', 'timeFrame': '48 months', 'description': 'Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.'}, {'measure': 'Transvalvular Mitral Valve Gradient', 'timeFrame': '60 months', 'description': 'Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.'}, {'measure': 'Mitral Valve Index', 'timeFrame': '30 days', 'description': 'Mitral valve area as measured by core lab echocardiography and indexed to body surface area \\[MVA Index = MVA (cm\\^2)/BSA (m\\^2)\\]'}, {'measure': 'Mitral Valve Index', 'timeFrame': '12 months', 'description': 'Mitral valve area as measured by core lab echocardiography and indexed to body surface area \\[MVA Index = MVA (cm\\^2)/BSA (m\\^2)\\]'}, {'measure': 'Number of Participants With New Coumadin Use', 'timeFrame': '30 days', 'description': 'New onset use of Coumadin or warfarin to treat a potential thrombus on a defibrillator lead.'}, {'measure': 'Number of Participants With New Coumadin Use', 'timeFrame': '6 months', 'description': 'New onset use of Coumadin or warfarin to treat a potential thrombus on a defibrillator lead.'}, {'measure': 'Number of Participants With New Coumadin Use', 'timeFrame': '12 months', 'description': 'New onset use of Coumadin or warfarin to treat a potential thrombus on a defibrillator lead.'}, {'measure': 'Number of Participants Discharged to a Nursing Home or Skilled Nursing Facility or Hospital', 'timeFrame': '30 Days', 'description': 'Discharge to a nursing home or skilled nursing facility following discharge from the hospital after definitive treatment.'}, {'measure': 'Post-procedure Length of Hospital Stay', 'timeFrame': 'Length of Hospital Stay, assessed at 30 days', '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': 'Post-procedure Intensive Care Unit (ICU)/ Critical Care Unit (CCU) Time', 'timeFrame': 'Length of ICU/CCU stay, assessed at 30 Days', 'description': 'Number of hours patients are in an intensive care unit or step down unit before discharge or moving to a standard care unit.'}, {'measure': 'Number of Participants With Successful Clip Implant', 'timeFrame': '30 Days', 'description': 'Rate of successful delivery and deployment of Clip implants with echocardiographic evidence of leaflet approximation and retrieval of the investigational delivery catheter.'}, {'measure': 'Number of Participants With High Risk Procedural Success', 'timeFrame': '30 days', 'description': '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.'}, {'measure': 'Number of Participants With MR Severity', 'timeFrame': 'Discharge or 30 days', 'description': 'MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.'}, {'measure': 'Number of Participants With MR Severity', 'timeFrame': '12 months', 'description': 'MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.'}, {'measure': 'Number of Participants With MR Severity', 'timeFrame': '24 months', 'description': 'MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.'}, {'measure': 'Number of Participants With MR Severity', 'timeFrame': '36 months', 'description': 'MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.'}, {'measure': 'Number of Participants With MR Severity', 'timeFrame': '48 months', 'description': 'MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.'}, {'measure': 'Number of Participants With MR Severity', 'timeFrame': '60 months', 'description': 'MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.'}, {'measure': 'Number of Participants With Treatment Durability', 'timeFrame': '12 months', 'description': 'Defined as the proportion of Acute Procedural Success patients with MR severity grade of 2+ or less that have not required surgery for valve dysfunction.'}, {'measure': 'Number of Participants With Treatment Durability', 'timeFrame': '24 months', 'description': 'Defined as the proportion of Acute Procedural Success patients with MR severity grade of 2+ or less that have not required surgery for valve dysfunction.'}, {'measure': 'Number of Participants With Clinical Durability', 'timeFrame': '12 months', 'description': 'Proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that 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.'}, {'measure': 'Number of Participants With Clinical Durability', 'timeFrame': '24 months', 'description': 'Proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that 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.'}, {'measure': 'Number of Participants With Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class', 'timeFrame': '24 months', 'description': '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 Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class', 'timeFrame': '36 months', 'description': '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 Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class', 'timeFrame': '48 months', 'description': '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 New York Heart Association (NYHA) Class', 'timeFrame': '60 months', 'description': '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': '24 months', 'description': 'Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).'}, {'measure': 'Left Ventricular End-diastolic Volume (LVEDV).', 'timeFrame': '36 months', 'description': 'Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).'}, {'measure': 'Left Ventricular End-diastolic Volume (LVEDV).', 'timeFrame': '48 months', 'description': 'Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).'}, {'measure': 'Left Ventricular End-diastolic Volume (LVEDV).', 'timeFrame': '60 months', 'description': 'Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).'}, {'measure': 'Left Ventricular End-systolic Volume (LVESV).', 'timeFrame': '24 months', 'description': 'Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).'}, {'measure': 'Left Ventricular End-systolic Volume (LVESV).', 'timeFrame': '36 months', 'description': 'Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).'}, {'measure': 'Left Ventricular End-systolic Volume (LVESV).', 'timeFrame': '48 months', 'description': 'Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).'}, {'measure': 'Left Ventricular End-systolic Volume (LVESV).', 'timeFrame': '60 months', 'description': 'Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).'}, {'measure': 'Left Ventricular Measurement: Left Ventricular Internal Dimension Diastole (LVIDd), Left Ventricular Internal Dimension Systole (LVIDs)', 'timeFrame': '24 months', 'description': 'Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).'}, {'measure': 'Left Ventricular Measurement: Left Ventricular Internal Dimension Diastole (LVIDd), Left Ventricular Internal Dimension Systole (LVIDs)', 'timeFrame': '36 months', 'description': 'Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).'}, {'measure': 'Left Ventricular Measurement: Left Ventricular Internal Dimension Diastole (LVIDd), Left Ventricular Internal Dimension Systole (LVIDs)', 'timeFrame': '48 months', 'description': 'Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).'}, {'measure': 'Left Ventricular Measurement: Left Ventricular Internal Dimension Diastole (LVIDd), Left Ventricular Internal Dimension Systole (LVIDs)', 'timeFrame': '60 months', 'description': 'Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).'}, {'measure': 'Number of Days Re-hospitalized for CHF', 'timeFrame': '12 months', 'description': 'Defined as the number of days hospitalized for CHF in the 12-months prior to the Clip implant procedure date compared to the number of days re-hospitalized for CHF in the 12-months after Clip implant.'}, {'measure': 'Number of Hospital Re-Admissions for Congestive Heart Failure (CHF)', 'timeFrame': '12 months', 'description': 'Defined as the number of hospital admissions (i.e. events) for which the primary diagnosis for hospitalization is congestive heart failure, in the 12-months post-discharge following the MitraClip procedure.'}, {'measure': 'Regurgitant Volume', 'timeFrame': '30 days', 'description': 'Regurgitant volume as measured by the core echocardiographic laboratory at follow-up.'}, {'measure': 'Regurgitant Volume', 'timeFrame': '12 months', 'description': 'Regurgitant volume as measured by the core echocardiographic laboratory at follow-up.'}, {'measure': 'Regurgitant Volume', 'timeFrame': '24 months', 'description': 'Regurgitant volume as measured by the core echocardiographic laboratory at follow-up.'}, {'measure': 'Regurgitant Fraction (RF)', 'timeFrame': '30 days', 'description': 'RF is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.'}, {'measure': 'Regurgitant Fraction', 'timeFrame': '12 months', 'description': 'RF is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.'}, {'measure': 'Regurgitant Fraction', 'timeFrame': '24 months', 'description': 'RF is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.'}, {'measure': 'Cardiac Output (CO)', 'timeFrame': '30 Days', 'description': 'CO is defined as the volume of blood pumped by the left ventricle per unit time (L/min).'}, {'measure': 'Cardiac Output', 'timeFrame': '12 months', 'description': 'CO is defined as the volume of blood pumped by the left ventricle per unit time (L/min)'}, {'measure': 'Cardiac Output', 'timeFrame': '24 months', 'description': 'CO is defined as the volume of blood pumped by the left ventricle per unit time (L/min)'}, {'measure': 'Cardiac Index', 'timeFrame': '30 Days', 'description': 'Cardiac index (cardiac output divided by body surface area) as measured by core lab echocardiography.'}, {'measure': 'Cardiac Index', 'timeFrame': '12 months', 'description': 'Cardiac index (cardiac output divided by body surface area) as measured by core lab echocardiography.'}, {'measure': 'Cardiac Index', 'timeFrame': '24 months', 'description': 'Cardiac index (cardiac output divided by body surface area) as measured by core lab echocardiography.'}, {'measure': 'Left Ventricular Ejection Fraction (LVEF)', 'timeFrame': 'Discharge or 30 days', 'description': 'Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.'}, {'measure': 'Left Ventricular Ejection Fraction (LVEF)', 'timeFrame': '12 months', 'description': 'Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.'}, {'measure': 'Left Ventricular Ejection Fraction (LVEF)', 'timeFrame': '24 months', 'description': 'Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.'}, {'measure': 'Left Ventricular Ejection Fraction (LVEF)', 'timeFrame': '36 months', 'description': 'Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.'}, {'measure': 'Left Ventricular Ejection Fraction (LVEF)', 'timeFrame': '48 months', 'description': 'Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.'}, {'measure': 'Left Ventricular Ejection Fraction (LVEF)', 'timeFrame': '60 months', 'description': 'Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.'}, {'measure': 'Percentage of Participants With Freedom From Mitral Valve Surgery', 'timeFrame': 'Baseline', 'description': 'Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure'}, {'measure': 'Percentage of Participants With Freedom From Mitral Valve Surgery', 'timeFrame': '12 months', 'description': 'Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure'}, {'measure': 'Percentage of Participants With Freedom From Mitral Valve Surgery', 'timeFrame': '24 months', 'description': 'Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure'}, {'measure': 'Percentage of Participants With Freedom From Mitral Valve Surgery', 'timeFrame': '36 months', 'description': 'Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure'}, {'measure': 'Percentage of Participants With Freedom From Mitral Valve Surgery', 'timeFrame': '48 months', 'description': 'Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure'}, {'measure': 'Percentage of Participants With Freedom From Mitral Valve Surgery', 'timeFrame': '60 months', 'description': 'Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure'}, {'measure': 'Number of Participants With Mitral Valve Repair Success', 'timeFrame': '12 months', 'description': 'Mitral Valve Repair Success defined as freedom from mitral valve replacement surgery for valve dysfunction, death, re-operation and MR \\> 2+ at 12 months.'}, {'measure': 'Number of Participants With Mitral Valve Repair Success', 'timeFrame': '24 months', 'description': 'Freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR \\> 2+.'}, {'measure': 'Composite Functional and Structural Measures - Percentage of Participants With Freedom From Death', 'timeFrame': '24 months', 'description': 'Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint. Death is further divided into 2 categories:\n\nA. Cardiac death is defined as death due to any of the following:\n\n1. Acute myocardial infarction.\n2. Cardiac perforation/pericardial tamponade.\n3. Arrhythmia or conduction abnormality.\n4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure.\n5. Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.\n6. Any death for which a cardiac cause cannot be excluded.\n\nB. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).'}, {'measure': 'Percentage of Participants With Composite Functional and Structural Measures - Freedom From Death and MR >2+', 'timeFrame': '24 months', 'description': 'Kaplan-Meier estimated proportion of patients who are alive and have a mitral regurgitation severity grade of 2+ or less.'}, {'measure': 'Number of Participants With Device Embolization or Single Leaflet Device Attachment', 'timeFrame': '0 to 12 months', 'description': 'Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.\n\nA single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.'}, {'measure': 'Number of Participants With Device Embolization or Single Leaflet Device Attachment', 'timeFrame': '24 months', 'description': 'Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.\n\nA single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.'}, {'measure': 'Number of Participants With Device Embolization or Single Leaflet Device Attachment', 'timeFrame': '48 months', 'description': 'Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.\n\nA single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.'}, {'measure': 'Number of Participants With Device Embolization or Single Leaflet Device Attachment', 'timeFrame': '36 months', 'description': 'Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.\n\nA single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.'}, {'measure': 'Number of Participants With Device Embolization or Single Leaflet Device Attachment', 'timeFrame': '60 months', 'description': 'Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.\n\nA single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.'}, {'measure': 'Number of Participants With Mitral Valve Surgery Post-MitraClip Procedure', 'timeFrame': '60 months', 'description': 'Number of patients who underwent surgical mitral valve repair or replacement after the index MitraClip procedure.'}, {'measure': 'Number of Participants With Second MitraClip Device Implanted', 'timeFrame': '0 to 5 years', 'description': 'It is a summary of re-interventions to place an additional MitraClip Device.'}, {'measure': 'Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery', 'timeFrame': '12 months', 'description': 'Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure'}, {'measure': 'Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery', 'timeFrame': '24 months', 'description': 'Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure'}, {'measure': 'Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery', 'timeFrame': '36 months', 'description': 'Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure'}, {'measure': 'Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery', 'timeFrame': '48 months', 'description': 'Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure'}, {'measure': 'Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery', 'timeFrame': '60 months', 'description': 'Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure'}, {'measure': 'Number of Participants With Mitral Valve Replacement', 'timeFrame': '12 months', 'description': 'Defined as how often patients receiving surgery required replacement of the mitral valve.'}, {'measure': 'Number of Participants With Mitral Valve Replacement', 'timeFrame': '24 months', 'description': 'Defined as how often patients receiving surgery required replacement of the mitral valve.'}, {'measure': 'Number of Participants With Mitral Valve Replacement', 'timeFrame': '36 months', 'description': 'Defined as how often patients receiving surgery required replacement of the mitral valve.'}, {'measure': 'Number of Participants With Mitral Valve Replacement', 'timeFrame': '48 months', 'description': 'Defined as how often patients receiving surgery required replacement of the mitral valve.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mitral Valve Insufficiency', 'Mitral Valve Regurgitation', 'Mitral Valve Incompetence', 'Mitral Regurgitation', 'Mitral Insufficiency', 'Mitral Valve', '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': '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': '30077993', 'type': 'DERIVED', 'citation': 'Kar S, Feldman T, Qasim A, Trento A, Kapadia S, Pedersen W, Lim DS, Kipperman R, Smalling RW, Bajwa T, Hermann HC, Hermiller JB, Lasala JM, Reisman M, Glower D, Mauri L, Whitlow P; EVEREST II Investigators. Five-year outcomes of transcatheter reduction of significant mitral regurgitation in high-surgical-risk patients. Heart. 2019 Nov;105(21):1622-1628. doi: 10.1136/heartjnl-2017-312605. Epub 2018 Aug 4.'}, {'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.'}], 'seeAlsoLinks': [{'url': 'https://www.vascular.abbott/us/homepage.html', 'label': 'Sponsor information'}]}, 'descriptionModule': {'briefSummary': 'Prospective, multi-center, single arm registry. Clinical follow-up at discharge, 30 days, 6, 12, 18 and 24, months, and 3, 4 and 5 years.\n\nConcurrent Control (CC) group identified retrospectively from the patients screened for the HRR who did not enroll; patient survival determined at 12 months. NCT00209274 (EVEREST II RCT) Intended use Percutaneous reduction of clinically significant mitral regurgitation in symptomatic patients who are considered to be high risk for operative mortality (high surgical risk).', 'detailedDescription': 'The EVEREST II HRR is a single-arm prospective, multicenter clinical trial enrolling high surgical risk patients of the EVEREST II study (NCT00209274).\n\nPatients were considered high surgical risk if either their Society of Thoracic Surgery (STS) predicted operative mortality risk was ≥ 12%, or the surgeon investigator determined the patient to be high risk (≥ 12% predicted operative mortality risk) due to the presence of, at a minimum, one of the following pre-specified risk factors:\n\n* Porcelain aorta or mobile ascending aortic atheroma\n* Post-radiation mediastinum\n* Previous mediastinitis\n* Functional MR with ejection fraction (EF) \\< 40%\n* Over 75 years old with EF \\< 40%\n* Prior re-operation with patent grafts\n* Two or more prior chest surgeries\n* Hepatic cirrhosis\n* Three or more of the following STS high risk factors:\n\n i. Creatinine \\> 2.5 mg/dL ii. Prior chest surgery iii. Age over 75 iv. EF \\< 35%\n\nUpon completion of enrollment in the HRR, a process was initiated to ensure patient consent to participate in a Concurrent Control (CC) group was in place. Patients were identified to determine survival through 12 months with current standard of care treatment.CC patients were derived from a cohort of patients screened for enrollment in the HRR,yet did not enroll. All patients had moderate-to-severe (3+) or severe (4+) MR based on transthoracic echocardiography (TTE). To be considered eligible for inclusion in the CC group, the patient had to be classified as high surgical risk using the same criteria used for the HRR. Upon follow-up with the clinical sites, it was determined that some of the initially identified patients with moderate-to-severe (3+) or severe (4+) MR met the criteria for high surgical risk. Of these patients, some were not included due to; lack of Institutional Review Board (IRB) approval at the site, lack of informed consent and unable to be contacted. The remaining patients make up the CC group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nCandidates for the high risk arm of the study must meet all of the following inclusion criteria:\n\n* Predicted procedural mortality risk calculated using the STS surgical risk calculator of ≥ 12% or in the judgment of the surgeon investigator the patient is considered a high risk 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 i Three or more of the following STS high risk factors: i) Creatinine \\> 2.5 mg/dL ii) Prior chest surgery iii) Age over 75 iv) EF\\<35\n* Age 18 years or older.\n* Symptomatic moderate to severe (3+) or severe (4+) chronic mitral regurgitation (MR) and in the judgment of the investigator intervention to reduce MR is likely to provide symptomatic relief for the patient. MR is determined as defined in Appendix A of the EVEREST II study protocol. American Society of Anesthesiologists (ASA) physical status classification of ASA IV or lower.\n* The primary regurgitant jet originates from malcoaptation of the A2 and P2 scallops of the mitral valve.\n* Male or Female. Female subjects of childbearing potential must have a negative pregnancy test within seven (7) days before the procedure.\n* The subject or the subject's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board of the respective clinical site.\n* The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.\n* Transseptal catheterization is determined to be feasible by the treating physician.\n\nExclusion Criteria:\n\nCandidates will be excluded from the study if any of the following conditions are present:\n\n* Evidence of an acute myocardial infarction in the prior 2 weeks of the intended treatment (defined as: Q wave or non-Q wave infarction having creatine kinase (CK) enzymes ≥ two times (2X) the upper laboratory normal limit with the presence of a Creatine Kinase MB Isoenzyme (CKMB) elevated above the institution's upper limit of normal).\n* In the judgment of the Investigator, the femoral vein cannot accommodate a 24 F catheter or presence of ipsilateral deep vein thrombosis (DVT).\n* Ejection fraction \\< 20%, and/or end-systolic dimension \\> 60 mm as defined in Appendix A of the EVEREST II protocol.\n* Mitral valve orifice area \\< 4.0 cm2 as defined in Appendix A of the EVEREST II protocol.\n* If leaflet flail is present:\n\n 1. Flail Width: the width of the flail segment is greater than or equal to 15 mm, as defined in Section 4.3 and Appendix A, or\n 2. Flail Gap: the flail gap is greater than or equal to 10 mm, as defined in Section 4.3 and Appendix A.\n* If leaflet tethering is present:\n\n a). Coaptation Length: the vertical coaptation length is less than 2 mm, as defined in Section 4.3 and Appendix A.\n* Leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in MR. This may include:\n* Evidence of calcification in the grasping area of the A2 and/or P2 scallops\n* Presence of a significant cleft of A2 or P2 scallops\n* More than one anatomic criteria dimensionally near the exclusion limits\n* Bileaflet flail or severe bileaflet prolapse\n* Lack of both primary and secondary chordal support\n* Hemodynamic instability defined as systolic pressure \\< 90 mmHg without after load reduction or cardiogenic shock or the need for inotropic support or intra-aortic balloon pump.\n* Need for emergent or urgent surgery for any reason.\n* Prior mitral valve leaflet surgery or any currently implanted mechanical prosthetic mitral valve.\n* Echocardiographic evidence of intracardiac mass, thrombus or vegetation.\n* Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic diseased (i.e. noncompliant, perforated).\n* History of bleeding diathesis or coagulopathy or subject will refuse blood transfusions.\n* Active infections requiring current antibiotic therapy (if temporary illness, patients may enroll 2 weeks after discontinuation of antibiotics). Patients must be free from infection prior to treatment. Any required dental work should be completed a minimum of 3 weeks prior to treatment.\n* Intravenous drug abuse or suspected inability to adhere to follow-up.\n* Patients in whom transesophageal echocardiography (TEE) is contraindicated.\n* A known hypersensitivity or contraindication to study or\n* In the judgment of the Investigator, patients in whom the presence of a permanent pacemaker or pacing leads would interfere with placement of the test device or the placement of the test device would disrupt the leads.\n* Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. \\[Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials\\]."}, 'identificationModule': {'nctId': 'NCT01940120', 'acronym': 'HRR', 'briefTitle': 'EVEREST II Pivotal Study High Risk Registry (HRR)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'A Study of the Evalve® Cardiovascular Valve Repair (MitraClip®) System Endovascular Valve Edge-to-Edge REpair STudy (EVEREST II) EVEREST II High Risk Registry', 'orgStudyIdInfo': {'id': '0401A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High Risk Registry Arm', 'description': 'Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.', 'interventionNames': ['Device: Percutaneous mitral valve repair using MitraClip implant']}], 'interventions': [{'name': 'Percutaneous mitral valve repair using MitraClip implant', 'type': 'DEVICE', 'otherNames': ['MitraClip', 'MitraClip Implant'], 'description': 'Procedure/Surgery: Mitral valve repair or replacement surgery Repair or replacement of mitral valve', 'armGroupLabels': ['High Risk Registry Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Evanston Northwestern Healthcare 2650 Ridge Ave., Walgreen Bldg, 3rd Floor, Cardiology', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '46290', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'The Care Group Heart Center 10590 N. Meridian, Ste. 300', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Ted Feldman, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Endeavor Health'}, {'name': 'Donald G Glower Jr.,, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University Medical Center, Department of Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}