Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-02-20 @ 10:12 PM
Study NCT ID:
NCT04177394
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-11
First Post:
2019-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MitraClip EXPAND G4 Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'melody.dong@abbott.com', 'phone': '4086434617', 'title': 'Melody Dong', 'organization': 'Abbott'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'All-Cause Mortality and Adverse Events are reported through 30 days.', 'description': 'Rates are reported as number of patients with an event out of the total number of patients in the study.', 'eventGroups': [{'id': 'EG000', 'title': 'MitraClip G4 System', 'description': 'Percutaneous mitral valve repair using the MitraClip G4 system\n\nMitraClip G4 System: Percutaneous mitral valve repair using the MitraClip G4 system.', 'otherNumAtRisk': 1164, 'deathsNumAtRisk': 1164, 'otherNumAffected': 0, 'seriousNumAtRisk': 1164, 'deathsNumAffected': 16, 'seriousNumAffected': 209}], 'seriousEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'ANAEMIA OF CHRONIC DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'ANGINA PECTORIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'ARRHYTHMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'ATRIAL FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'ATRIAL SEPTAL DEFECT ACQUIRED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'CARDIAC FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 37, 'numAffected': 37}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'CARDIAC FAILURE CONGESTIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 18, 'numAffected': 16}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'CARDIAC PERFORATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'CARDIO-RESPIRATORY ARREST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'CARDIOGENIC SHOCK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'LEFT VENTRICULAR DYSFUNCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'MITRAL PERFORATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'MITRAL VALVE INCOMPETENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'MITRAL VALVE STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'MYOCARDIAL ISCHAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'TRICUSPID VALVE INCOMPETENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'DYSPHAGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'GASTROINTESTINAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'UPPER GASTROINTESTINAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'CARDIAC COMPLICATION ASSOCIATED WITH DEVICE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'DEATH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'DEVICE CAPTURING ISSUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'CHOLECYSTITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'HEPATIC FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'CARDIAC INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 21, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'PNEUMOTHORAX TRAUMATIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'PROCEDURAL HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'VASCULAR ACCESS COMPLICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'VASCULAR PROCEDURE COMPLICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'ANTICOAGULATION DRUG LEVEL BELOW THERAPEUTIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'MEAN ARTERIAL PRESSURE DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'OXYGEN SATURATION DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'METABOLISM AND NUTRITION DISORDERS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'HYPERKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'METABOLIC ACIDOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'MOBILITY DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'NEOPLASM MALIGNANT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'CEREBROVASCULAR ACCIDENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'CONVULSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'ISCHAEMIC STROKE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'METABOLIC ENCEPHALOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'SIMPLE PARTIAL SEIZURES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'SOMNOLENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'TRANSIENT ISCHAEMIC ATTACK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'UNRESPONSIVE TO STIMULI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'DELIRIUM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'RENAL FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'ACUTE RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'CHRONIC OBSTRUCTIVE PULMONARY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'DYSPNOEA EXERTIONAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'HYPOXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'PLEURAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'PULMONARY HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'ARTERIAL OCCLUSIVE DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 42, 'numAffected': 39}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'ORTHOSTATIC HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Mitral Valve Regurgitation Severity ≤2+ at 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '983', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MitraClip G4 System', 'description': 'Percutaneous mitral valve repair using the MitraClip G4 system\n\nMitraClip G4 System: Percutaneous mitral valve repair using the MitraClip G4 system.'}], 'classes': [{'categories': [{'title': '0+:None', 'measurements': [{'value': '350', 'groupId': 'OG000'}]}, {'title': '1+: Mild', 'measurements': [{'value': '547', 'groupId': 'OG000'}]}, {'title': '2+: Moderate', 'measurements': [{'value': '65', 'groupId': 'OG000'}]}, {'title': '3+: Moderate to Severe', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': '4+: Severe', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 30 days', 'description': 'Mitral Valve Regurgitation (MR) Severity of 2+ or less at 30 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data has been reported'}, {'type': 'PRIMARY', 'title': 'Occurrence of Major Adverse Events (MAE) at 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1159', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MitraClip G4 System', 'description': 'Percutaneous mitral valve repair using the MitraClip G4 system\n\nMitraClip G4 System: Percutaneous mitral valve repair using the MitraClip G4 system.'}], 'classes': [{'title': 'All Cause Death', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Myocardial Infarction', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Stroke', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Non-elective CV Surgery for device related complications', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 30 days', 'description': 'MAE is defined as a composite of all-cause Death, Myocardial Infarction, Stroke, or non-elective Cardiovascular (CV) surgery for device related complications.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data has been reported'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With APS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1159', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MitraClip G4 System', 'description': 'Percutaneous mitral valve repair using the MitraClip G4 system\n\nMitraClip G4 System: Percutaneous mitral valve repair using the MitraClip G4 system.'}], 'classes': [{'categories': [{'measurements': [{'value': '1119', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 10 Days', 'description': 'Acute Procedural Success (APS) defined as successful implantation of the MitraClip device with resulting MR severity of 2+ or less on discharge echocardiogram. Echocardiogram (30-day echocardiogram will be used if discharge is unavailable or uninterpretable). Subjects who die or undergo mitral valve surgery before discharge are considered to be an APS failure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data has been reported.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With ADS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1164', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MitraClip G4 System', 'description': 'Percutaneous mitral valve repair using the MitraClip G4 system\n\nMitraClip G4 System: Percutaneous mitral valve repair using the MitraClip G4 system.'}], 'classes': [{'categories': [{'measurements': [{'value': '1118', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 10 Days', 'description': 'Acute Device Success defined as successful implant of the MitraClip device without the occurrence of a Device-Related Complication (including device embolization, Single Leaflet Device Attachment (SLDA), bleeding, or perforation) through discharge.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data has been reported.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Occurrence of In-hospital Major Adverse Events (MAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1164', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MitraClip G4 System', 'description': 'Percutaneous mitral valve repair using the MitraClip G4 system\n\nMitraClip G4 System: Percutaneous mitral valve repair using the MitraClip G4 system.'}], 'classes': [{'title': 'All Cause Death', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Myocardial Infarction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Stroke', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Non-elective CV surgery for device related complications', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days', 'description': 'In-hospital Major Adverse Events (MAE) defined as the number of MAEs that occur prior to discharge from hospitalization in which MitraClip Procedure was performed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of All Cause Mortality Through 5 Years', 'timeFrame': 'Through 5 years', 'description': 'All Cause Mortality Through 5 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Heart Failure Hospitalization Through 5 Years', 'timeFrame': 'Through 5 years', 'description': 'Heart Failure Hospitalization through 5 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Occurrence of MAE', 'timeFrame': 'Through 5 years', 'description': 'Occurrence of Major Adverse Events (MAE) as defined in the protocol through 5 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Device Related Complications as Defined in the Protocol Through 5 Years', 'timeFrame': 'Through 5 years', 'description': 'Device Related Complications as defined in the protocol through 5 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With MR Reduction to ≤2+ or Less at Discharge, 30 Days, 1 and 5 Year', 'timeFrame': 'Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days, and at 30 days, 1 and 5 year', 'description': 'MR Reduction to ≤2+ at Discharge, 30 days, 1 and 5 year', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With MR Reduction to ≤1+ or Less at Discharge, 30 Days, 1 and 5 Year', 'timeFrame': 'Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days, and at 30 days, 1 and 5 year', 'description': 'MR Reduction to ≤1+ at Discharge, 30 days, 1 and 5 year', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Difference Between New York Heart Association (NYHA) at Discharge, 30 Days, 1, 2, 3, 4 and 5 Years, Higher Class Means a Worse Outcome (Class I to IV)', 'timeFrame': 'Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days, and at 30 days, 1, 2, 3, 4 and 5 years', 'description': 'Difference Between NYHA Class at Discharge, 30 days, 1, 2, 3, 4 and 5 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Difference Between Kansas City Cardiomyopathy Questionnaire (KCCQ) Score at 30 Days, 1, 2, 3, 4 and 5 Year, Higher Score Means a Better Outcome (0-100)', 'timeFrame': '30 days, 1, 2, 3, 4 and 5 year', 'description': 'Difference Between QOL at 30 days, 1, 2, 3, 4 and 5 year', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Difference Between 6 Minutes Walk Distance (6MWD) at 30 Days, 1 and 5 Year', 'timeFrame': '30 days, 1, 2, 3, 4 and 5 year', 'description': 'Difference Between 6MWD at 30 days, 1, 2, 3, 4 and 5 year', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MitraClip G4 System', 'description': 'Percutaneous mitral valve repair using the MitraClip G4 system\n\nMitraClip G4 System: Percutaneous mitral valve repair using the MitraClip G4 system.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1164'}]}, {'type': 'COMPLETED', 'comment': 'Participant Flow is for 30 Days', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1053'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'Missed visits', 'reasons': [{'groupId': 'FG000', 'numSubjects': '61'}]}, {'type': 'Expected Visits', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1164', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'MitraClip G4 System', 'description': 'Percutaneous mitral valve repair using the MitraClip G4 system\n\nMitraClip G4 System: Percutaneous mitral valve repair using the MitraClip G4 system.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1164', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '77.5', 'spread': '9.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1164', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '514', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '650', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Saudi Arabia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1164', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1164', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Netherlands', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1164', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1164', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '586', 'groupId': 'BG000'}]}]}, {'title': 'Japan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1164', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '95', 'groupId': 'BG000'}]}]}, {'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1164', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '144', 'groupId': 'BG000'}]}]}, {'title': 'Israel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1164', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1164', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1164', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '232', 'groupId': 'BG000'}]}]}, {'title': 'Spain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1164', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1163', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '167.78', 'spread': '11.26', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All available data has been reported.'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1164', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '73.25', 'spread': '18.91', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1163', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '25.91', 'spread': '5.89', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All available data has been reported'}, {'title': 'Euro Score II', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '472', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6.48', 'spread': '6.85', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'EuroSCORE II estimates the 30-day mortality risk after cardiac surgery, expressed as a percentage. EuroSCORE II score has three groups, 1. low risk defined as EuroSCORE \\< 4%, 2. intermediate risk as 4-8%, and 3. high risk as \\> 8%.', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All available data has been reported'}, {'title': 'STS Replacement Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '608', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7.55', 'spread': '6.21', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "The Society of Thoracic Surgeons (STS) score is a validated risk-prediction model for open surgery based on data from the STS National Adult Cardiac Surgery Database. In general, an STS predicted risk of surgical mortality of 4%-8% is considered intermediate risk and 8% or greater is considered high risk. As of November 15, 2018, The STS released an updated short-term risk calculator to reflect the latest 2018 adult cardiac surgery risk models. The STS Calculator allows you to calculate a patient's risk of mortality and morbidities for the most commonly performed cardiac surgeries.", 'unitOfMeasure': 'percentage', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All available data has been reported'}, {'title': 'Prior Cardiac Sugeries', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1164', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '266', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior Coronary Revascularization', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1164', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '448', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Coronary Artery Bypass Graft (CABG)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1164', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '176', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior Cardiac Interventions (PCI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1164', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '364', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Permanent Pacemaker', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1164', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '315', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior Heart Failure Hospitalization within 1 year', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1164', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '472', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All 1164 subjects completed the Baseline visit'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-04', 'size': 5047666, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-05-15T15:28', 'hasProtocol': True}, {'date': '2024-02-16', 'size': 450060, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-02-22T02:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1164}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-09', 'studyFirstSubmitDate': '2019-11-22', 'resultsFirstSubmitDate': '2023-05-17', 'studyFirstSubmitQcDate': '2019-11-22', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-02', 'studyFirstPostDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With APS', 'timeFrame': 'Up to 10 Days', 'description': 'Acute Procedural Success (APS) defined as successful implantation of the MitraClip device with resulting MR severity of 2+ or less on discharge echocardiogram. Echocardiogram (30-day echocardiogram will be used if discharge is unavailable or uninterpretable). Subjects who die or undergo mitral valve surgery before discharge are considered to be an APS failure'}, {'measure': 'Number of Participants With ADS', 'timeFrame': 'Up to 10 Days', 'description': 'Acute Device Success defined as successful implant of the MitraClip device without the occurrence of a Device-Related Complication (including device embolization, Single Leaflet Device Attachment (SLDA), bleeding, or perforation) through discharge.'}, {'measure': 'Occurrence of In-hospital Major Adverse Events (MAE)', 'timeFrame': 'Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days', 'description': 'In-hospital Major Adverse Events (MAE) defined as the number of MAEs that occur prior to discharge from hospitalization in which MitraClip Procedure was performed.'}, {'measure': 'Rate of All Cause Mortality Through 5 Years', 'timeFrame': 'Through 5 years', 'description': 'All Cause Mortality Through 5 years'}, {'measure': 'Number of Heart Failure Hospitalization Through 5 Years', 'timeFrame': 'Through 5 years', 'description': 'Heart Failure Hospitalization through 5 years'}, {'measure': 'Occurrence of MAE', 'timeFrame': 'Through 5 years', 'description': 'Occurrence of Major Adverse Events (MAE) as defined in the protocol through 5 years'}, {'measure': 'Rate of Device Related Complications as Defined in the Protocol Through 5 Years', 'timeFrame': 'Through 5 years', 'description': 'Device Related Complications as defined in the protocol through 5 years'}, {'measure': 'Percentage of Participants With MR Reduction to ≤2+ or Less at Discharge, 30 Days, 1 and 5 Year', 'timeFrame': 'Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days, and at 30 days, 1 and 5 year', 'description': 'MR Reduction to ≤2+ at Discharge, 30 days, 1 and 5 year'}, {'measure': 'Percentage of Participants With MR Reduction to ≤1+ or Less at Discharge, 30 Days, 1 and 5 Year', 'timeFrame': 'Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days, and at 30 days, 1 and 5 year', 'description': 'MR Reduction to ≤1+ at Discharge, 30 days, 1 and 5 year'}, {'measure': 'Difference Between New York Heart Association (NYHA) at Discharge, 30 Days, 1, 2, 3, 4 and 5 Years, Higher Class Means a Worse Outcome (Class I to IV)', 'timeFrame': 'Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days, and at 30 days, 1, 2, 3, 4 and 5 years', 'description': 'Difference Between NYHA Class at Discharge, 30 days, 1, 2, 3, 4 and 5 years'}, {'measure': 'Difference Between Kansas City Cardiomyopathy Questionnaire (KCCQ) Score at 30 Days, 1, 2, 3, 4 and 5 Year, Higher Score Means a Better Outcome (0-100)', 'timeFrame': '30 days, 1, 2, 3, 4 and 5 year', 'description': 'Difference Between QOL at 30 days, 1, 2, 3, 4 and 5 year'}, {'measure': 'Difference Between 6 Minutes Walk Distance (6MWD) at 30 Days, 1 and 5 Year', 'timeFrame': '30 days, 1, 2, 3, 4 and 5 year', 'description': 'Difference Between 6MWD at 30 days, 1, 2, 3, 4 and 5 year'}], 'primaryOutcomes': [{'measure': 'Number of Participants With Mitral Valve Regurgitation Severity ≤2+ at 30 Days', 'timeFrame': 'At 30 days', 'description': 'Mitral Valve Regurgitation (MR) Severity of 2+ or less at 30 days'}, {'measure': 'Occurrence of Major Adverse Events (MAE) at 30 Days', 'timeFrame': 'At 30 days', 'description': 'MAE is defined as a composite of all-cause Death, Myocardial Infarction, Stroke, or non-elective Cardiovascular (CV) surgery for device related complications.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['MitraClip', 'MitraClip G4', 'Mitral Regurgitation'], 'conditions': ['Mitral Valve Regurgitation', 'Mitral Regurgitation']}, 'referencesModule': {'references': [{'pmid': '40713981', 'type': 'DERIVED', 'citation': 'Tang GHL, Price MJ, Rottbauer W, Mahoney PD, Hausleiter J, Raake PW, Rollefson WA, Lurz P, Denti P, Chehab BK, Dong M, Huang R, Asch FM, Zamorano JL, von Bardeleben RS, Maisano F, Kar S, Rodriguez E. Transcatheter Edge-to-Edge Repair in Secondary Mitral Regurgitation With Extended Non-COAPT-Like Features: From the EXPANDed Studies. JACC Heart Fail. 2025 Sep;13(9):102565. doi: 10.1016/j.jchf.2025.102565. Epub 2025 Jun 27.'}, {'pmid': '39619400', 'type': 'DERIVED', 'citation': 'Morikawa T, Enta Y, Sakamoto T, Yamamoto M, Ueno H, Yagasaki H, Asch FM, Dong M, Peterman K, Rodriguez E, von Bardeleben RS, Asami M. 1-Year Outcomes of Fourth-Generation Mitral Transcatheter Edge-to-Edge Repair in Japan From the EXPAND G4 Study. JACC Asia. 2024 Sep 24;4(11):810-821. doi: 10.1016/j.jacasi.2024.08.003. eCollection 2024 Nov.'}, {'pmid': '37877913', 'type': 'DERIVED', 'citation': 'von Bardeleben RS, Mahoney P, Morse MA, Price MJ, Denti P, Maisano F, Rogers JH, Rinaldi M, De Marco F, Rollefson W, Chehab B, Williams M, Leurent G, Asch FM, Rodriguez E. 1-Year Outcomes With Fourth-Generation Mitral Valve Transcatheter Edge-to-Edge Repair From the EXPAND G4 Study. JACC Cardiovasc Interv. 2023 Nov 13;16(21):2600-2610. doi: 10.1016/j.jcin.2023.09.029. Epub 2023 Oct 24.'}]}, 'descriptionModule': {'briefSummary': 'This primary objective of the EXPAND G4 study is to confirm the safety and performance of the MitraClip G4 System in a post-market setting.', 'detailedDescription': 'This is a post-market, multi-center, single-arm, prospective study to assess the safety and performance of the next generation MitraClip G4 System. The current protocol describes the design of this post-market study.\n\nUp to 1,100 post-market, consented patients will be treated with a MitraClip G4 device according to local guidelines and IFU from the Europe and Middle East, the United States, Canada and Japan, and will be included in the analysis for the MitraClip EXPAND G4 Study. Follow-up echocardiograms will be collected at Discharge, 30 days and 1 year and 5 year at post-procedure visits. Additional clinical follow-up visits will be at 6 months (phone call), 2, 3, 4 year (office visits). Cardiovascular adverse events will be reported through 5 years to confirm safety of the MitraClip G4 System.\n\nDuring the Phase 1 of the study 100 subjects were enrolled at 15 sites in the United States with the goal of evaluating the early safety and procedural outcomes associated with the MitraClip G4. The follow up duration was 30 days. Phase I was completed August 2020.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study will include an analysis of all consented subjects who satisfy the inclusion and exclusion criteria and who are treated with the MitraClip G4 System. The study will include approximately 1100 subjects treated with the MitraClip G4 System that have data available for assessment of APS.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects scheduled to receive the MitraClip per the current approved indications for use\n2. Subjects who give consent for their participation\n\nExclusion Criteria:\n\n1\\. Subjects participating in another clinical study that may impact the follow-up or results of this study'}, 'identificationModule': {'nctId': 'NCT04177394', 'briefTitle': 'MitraClip EXPAND G4 Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'A Post-Market Study Assessment of the Safety and Performance of the MitraClip G4 System', 'orgStudyIdInfo': {'id': 'ABT-CIP-10320'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MitraClip G4 System', 'description': 'Percutaneous mitral valve repair using the MitraClip G4 system', 'interventionNames': ['Device: MitraClip G4 System']}], 'interventions': [{'name': 'MitraClip G4 System', 'type': 'DEVICE', 'description': 'Percutaneous mitral valve repair using the MitraClip G4 system.', 'armGroupLabels': ['MitraClip G4 System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama 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