Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-03-01 @ 6:03 AM
Study NCT ID:
NCT03173534
Status:
COMPLETED
Last Update Posted:
2024-05-22
First Post:
2017-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
WATCH-TAVR, WATCHMAN for Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'KAPADIS@ccf.org', 'phone': '216 444-6735', 'title': 'Samir Kapadia, MD Chairman Cardiovascular Medicine', 'organization': 'Cleveland Clinic'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Events collected within two years following randomization.', 'eventGroups': [{'id': 'EG000', 'title': 'TAVR + Medical Therapy', 'description': 'n=175 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation\n\nTAVR: Transcatheter Aortic Valve Replacement', 'otherNumAtRisk': 172, 'deathsNumAtRisk': 172, 'otherNumAffected': 131, 'seriousNumAtRisk': 172, 'deathsNumAffected': 39, 'seriousNumAffected': 90}, {'id': 'EG001', 'title': 'TAVR + WATCHMAN', 'description': 'n=175 will undergo simultaneous Transcatheter Aortic Valve Replacement (TAVR) with a WATCHMAN device.\n\nWATCHMAN: WATCHMAN Device is composed of a self-expanding nitinol structure with a porous membrane on the proximal face. The implant device is delivered to the Left Atrial Appendage by femoral venous access and transseptal puncture to enter the left atrium.\n\nTAVR: Transcatheter Aortic Valve Replacement', 'otherNumAtRisk': 177, 'deathsNumAtRisk': 177, 'otherNumAffected': 127, 'seriousNumAtRisk': 177, 'deathsNumAffected': 37, 'seriousNumAffected': 87}], 'otherEvents': [{'term': 'Bleeding', 'notes': 'Event Associated with bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 57}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Cardiac - Other', 'notes': 'Cardiac- Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 57}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Rental', 'notes': 'Other- not bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 8}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Infection', 'notes': 'Other (except endocarditis and device infection)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Anemia', 'notes': 'Not associated with bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Any AE with symptoms that could possibly be contributed to WATCHMAN or TAVR device/procedure', 'notes': 'Any AE with symptoms that could possibly be contributed to WATCHMAN or TAVR device/procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Neurologic', 'notes': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Infection - UTI', 'notes': 'UTI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Cancer/Malignancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Cardiac - Sudden Cardiac Death/Cardiac Arrest', 'notes': 'Cardiac - Sudden Cardiac Death/Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Neurologic - Ischemic Stroke', 'notes': 'Ischemic Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Neurologic - TIA', 'notes': 'TIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Pulmonary - Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Pulmonary - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Cardiac - Angina/Chest Pain/CAD', 'notes': 'Angina/Chest Pain/CAD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Pulmonary - Pleural Effusion', 'notes': 'Pleural Effusion (not sanguineous)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'COVID-19 Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Pulmonary - Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'COD Unknown', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Cardiac - Pericardial Effusion (not hemorrhagic)', 'notes': 'Pericardial effusion (not hemorrhagic)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Neurologic - Stroke Type Unknown', 'notes': 'Stroke Type Unknown', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Neurologic - Mental Status Changes/Confusion', 'notes': 'Mental Status Changes/Confusion (not stroke or TIA)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Thrombosis - Venous (including DVT)', 'notes': 'Venous (including DVT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Renal- AKI (requiring dialysis)', 'notes': 'AKI (requiring dialysis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Rehospitalization related to TAVR device or procedure (not listed)', 'notes': 'Related to TAVR device or procedure (not listed)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Thrombus - Atrial (not arterial)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Cardiac - Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'GI- Other (not bleeding)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Cardiac - Myocardial Infarction', 'notes': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Thrombosis - Other Systemic (other than stroke)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Endocrine Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Pulmonary - Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Neurologic - Subdural Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Cardiac - AV Regurg/Leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Vascular Pseudoaneurysm', 'notes': 'no intervention required', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Thrombosis - WATCHMAN Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Septic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Cardiac - Atrial Septal Defect (latrogenic)', 'notes': 'Atrial Septal Defect (latrogenic)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Device Embolization - Catheter Retrieval', 'notes': 'Catheter Retrieval', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Pulmonary - COPD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Vascular Pseudoaneurysm', 'notes': 'requires endovascular repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Vascular AV Fistual', 'notes': 'intervention required', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Neoplasm Benign & Malignant', 'notes': 'Incl Cysts and Polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Cardiac - Heart Valve Damage', 'notes': 'Heart Valve Damage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Inflammatory/Immunologic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Thrombosis - TAVR Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Vascular AV Fistula', 'notes': 'no intervention required', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Thrombosis - Other NON Cardiac Device', 'notes': 'Other NON Cardiac Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Thrombosis - Other Cardiac Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Supra-therapeutic INR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Hepatobiliary (not bleeding)', 'notes': 'not bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Rehospitalization related to WATCHMAN procedure or device', 'notes': 'Related to WATCHMAN procedure or device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Pancreatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}], 'seriousEvents': [{'term': 'Cardiac - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 29}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Bleeding - Event Associated with bleeding', 'notes': 'Event associated with bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 31}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Cardiac - Heart Failure', 'notes': 'Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 18}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Renal - Other (not bleeding)', 'notes': 'Other- not bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 8}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Infection - Other (except endocarditis and device infection)', 'notes': 'Other (except endocarditis and device infection)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Cardiac - Sudden Cardiac Death/Cardiac Arrest', 'notes': 'Sudden Cardiac Death/Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Any AE with symptoms that could possibly be contributed to WATCHMAN or TAVR device/procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Anemia', 'notes': 'Not associated with bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Cancer/Malignancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Pulmonary - Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Neurologic - Ischemic Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Pulmonary - Pleural Effusion', 'notes': 'Pleural Effusion (not sanguineous)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Neurologic - Other', 'notes': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Neurologic - Stroke Type Unknown', 'notes': 'Stroke Type Unknown', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Renal - AKI (requiring dialysis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Cardiac - Pericardial Effusion (not hemorrhagic)', 'notes': 'Pericardial Effusion (not hemorrhagic)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'COVID-19 Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Rehospitalization related to TAVR device or procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Infection - UTI', 'notes': 'UTI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Thrombosis - Other systemic', 'notes': 'Other systemic (other than stroke)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'GI- Other (not bleeding)', 'notes': 'Other (not bleeding)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Cardiac - Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'COD Unknown', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Pulmonary - Embolism', 'notes': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Neurologic - TIA', 'notes': 'TIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Cardiac - Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Pulmonary - Other', 'notes': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Cardiac - AV Regurgitation/Leak', 'notes': 'AV Regurgitation/Leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Thrombosis - WATCHMAN Device', 'notes': 'WATCHMAN Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Thrombus- Atrial (not arterial)', 'notes': 'Atrial (not arterial)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Septic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Endocrine Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Cardiac - Angina/Chest Pain/CAD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Pulmonary - Pneumonia', 'notes': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Pulmonary - COPD', 'notes': 'COPD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Neurologic - Subdural Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Vascular Pseudoaneurysm', 'notes': 'Requires endovascular repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Vascular AV Fistula (intervention required)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Neruo- Mental Status Changes/Confusion (not stroke or TIA)', 'notes': 'Mental Status Changes/Confusion (not stroke or TIA)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Cardiac - Heart Valve Damage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Thrombosis - Venous (including DVT)', 'notes': 'Venous (including DVT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Thrombosis - TAVR Device', 'notes': 'TAVR Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Thrombosis - Other NON Cardiac Device', 'notes': 'Other NON Cardiac Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Supra-therapeutic INR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Hepatobiliary (not bleeding)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Rehospitalization related to WATCHMAN procedure or device (not listed above)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Device Embolization - Catheter Retrieval', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Cardiac - Heart Valve Damage', 'notes': 'Heart Valve Damage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Thrombosis- Venous (including DVT)', 'notes': 'Venous (including DVT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Thrombosis - TAVR Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}, {'term': 'Rehospitalization related to WATCHMAN procedure or device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'VARC 2 definitions'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Composite of All-cause Mortality, Stroke and Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR + Medical Therapy', 'description': 'n=175 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation\n\nTAVR: Transcatheter Aortic Valve Replacement'}, {'id': 'OG001', 'title': 'TAVR + WATCHMAN', 'description': 'n=175 will undergo simultaneous Transcatheter Aortic Valve Replacement (TAVR) with a WATCHMAN device.\n\nWATCHMAN: WATCHMAN Device is composed of a self-expanding nitinol structure with a porous membrane on the proximal face. The implant device is delivered to the Left Atrial Appendage by femoral venous access and transseptal puncture to enter the left atrium.\n\nTAVR: Transcatheter Aortic Valve Replacement'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through 2 year post-randomization', 'description': 'First occurrence of all-cause mortality, stroke (ischemic or hemorrhagic), or bleeding (life-threatening and major) events through 2 years post-randomization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'All-cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR + Medical Therapy', 'description': 'n=175 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation\n\nTAVR: Transcatheter Aortic Valve Replacement'}, {'id': 'OG001', 'title': 'TAVR + WATCHMAN', 'description': 'n=175 will undergo simultaneous Transcatheter Aortic Valve Replacement (TAVR) with a WATCHMAN device.\n\nWATCHMAN: WATCHMAN Device is composed of a self-expanding nitinol structure with a porous membrane on the proximal face. The implant device is delivered to the Left Atrial Appendage by femoral venous access and transseptal puncture to enter the left atrium.\n\nTAVR: Transcatheter Aortic Valve Replacement'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through 2 year post-randomization', 'description': 'All deaths through 2 year', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR + Medical Therapy', 'description': 'n=175 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation\n\nTAVR: Transcatheter Aortic Valve Replacement'}, {'id': 'OG001', 'title': 'TAVR + WATCHMAN', 'description': 'n=175 will undergo simultaneous Transcatheter Aortic Valve Replacement (TAVR) with a WATCHMAN device.\n\nWATCHMAN: WATCHMAN Device is composed of a self-expanding nitinol structure with a porous membrane on the proximal face. The implant device is delivered to the Left Atrial Appendage by femoral venous access and transseptal puncture to enter the left atrium.\n\nTAVR: Transcatheter Aortic Valve Replacement'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through 2 year post-randomization', 'description': 'First occurrence of any ischemic or hemorrhagic stroke through 2 year', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR + Medical Therapy', 'description': 'n=175 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation\n\nTAVR: Transcatheter Aortic Valve Replacement'}, {'id': 'OG001', 'title': 'TAVR + WATCHMAN', 'description': 'n=175 will undergo simultaneous Transcatheter Aortic Valve Replacement (TAVR) with a WATCHMAN device.\n\nWATCHMAN: WATCHMAN Device is composed of a self-expanding nitinol structure with a porous membrane on the proximal face. The implant device is delivered to the Left Atrial Appendage by femoral venous access and transseptal puncture to enter the left atrium.\n\nTAVR: Transcatheter Aortic Valve Replacement'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through 2 year post-randomization', 'description': 'First occurrence of any life-threatening or major bleeding through 2 year', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cardiovascular Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR + Medical Therapy', 'description': 'n=175 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation\n\nTAVR: Transcatheter Aortic Valve Replacement'}, {'id': 'OG001', 'title': 'TAVR + WATCHMAN', 'description': 'n=175 will undergo simultaneous Transcatheter Aortic Valve Replacement (TAVR) with a WATCHMAN device.\n\nWATCHMAN: WATCHMAN Device is composed of a self-expanding nitinol structure with a porous membrane on the proximal face. The implant device is delivered to the Left Atrial Appendage by femoral venous access and transseptal puncture to enter the left atrium.\n\nTAVR: Transcatheter Aortic Valve Replacement'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through 2 year post-randomization', 'description': 'Cardiovascular related mortality through 2 year', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Thrombus or Embolism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR + Medical Therapy', 'description': 'n=175 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation\n\nTAVR: Transcatheter Aortic Valve Replacement'}, {'id': 'OG001', 'title': 'TAVR + WATCHMAN', 'description': 'n=175 will undergo simultaneous Transcatheter Aortic Valve Replacement (TAVR) with a WATCHMAN device.\n\nWATCHMAN: WATCHMAN Device is composed of a self-expanding nitinol structure with a porous membrane on the proximal face. The implant device is delivered to the Left Atrial Appendage by femoral venous access and transseptal puncture to enter the left atrium.\n\nTAVR: Transcatheter Aortic Valve Replacement'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through 2 year post-randomization', 'description': 'Incidence of arterial or venous embolism', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Re-hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR + Medical Therapy', 'description': 'n=175 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation\n\nTAVR: Transcatheter Aortic Valve Replacement'}, {'id': 'OG001', 'title': 'TAVR + WATCHMAN', 'description': 'n=175 will undergo simultaneous Transcatheter Aortic Valve Replacement (TAVR) with a WATCHMAN device.\n\nWATCHMAN: WATCHMAN Device is composed of a self-expanding nitinol structure with a porous membrane on the proximal face. The implant device is delivered to the Left Atrial Appendage by femoral venous access and transseptal puncture to enter the left atrium.\n\nTAVR: Transcatheter Aortic Valve Replacement'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through 2 year post-randomization', 'description': 'Incidence of re-hospitalizations related to the WATCHMAN procedure or WATCHMAN device', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Quality of Life Score: KCCQ-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR + Medical Therapy', 'description': 'n=175 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation\n\nTAVR: Transcatheter Aortic Valve Replacement'}, {'id': 'OG001', 'title': 'TAVR + WATCHMAN', 'description': 'n=175 will undergo simultaneous Transcatheter Aortic Valve Replacement (TAVR) with a WATCHMAN device.\n\nWATCHMAN: WATCHMAN Device is composed of a self-expanding nitinol structure with a porous membrane on the proximal face. The implant device is delivered to the Left Atrial Appendage by femoral venous access and transseptal puncture to enter the left atrium.\n\nTAVR: Transcatheter Aortic Valve Replacement'}], 'classes': [{'title': 'KCCQ Questionnaire Score Visit 1-Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.77', 'spread': '15.55', 'groupId': 'OG000'}, {'value': '40.8', 'spread': '15.21', 'groupId': 'OG001'}]}]}, {'title': 'KCCQ Questionnaire Score Visit 2- 45 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.2', 'spread': '17.77', 'groupId': 'OG000'}, {'value': '55.1', 'spread': '17.94', 'groupId': 'OG001'}]}]}, {'title': 'KCCQ Questionnaire Score (Visit 3- 6 Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56.6', 'spread': '17.97', 'groupId': 'OG000'}, {'value': '57.61', 'spread': '15.18', 'groupId': 'OG001'}]}]}, {'title': 'KCCQ Questionnaire Score (Visit 4-12 Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56.3', 'spread': '18.42', 'groupId': 'OG000'}, {'value': '57.4', 'spread': '15.67', 'groupId': 'OG001'}]}]}, {'title': 'KCCQ Questionnaire Score (Visit 5- 24 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.1', 'spread': '18.99', 'groupId': 'OG000'}, {'value': '57.0', 'spread': '16.51', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through 2 year post-randomization', 'description': "Change from baseline in quality of life (QoL) as measured using the KCCQ-12 score. Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated tool used to assess heart failure and how it affects the participant's life. Four domain scores and one summary score are generated from the KCCQ-12: Physical Limitation Score, Symptom Frequency Score, Quality of Life Score, Social Limitation Score and a Summary Score. Scale ranges for each question 1 to 6 (Extremely limited 1, Quite a bit limited 2, Moderately limited 3, Slightly limited 4, Not at all limited 5, Limited for other reasons or did not do the activity 6. The Summary score represents an integration of the patient's physical limitation, symptom frequency, quality of life and social limitation. The total score is calculated as the average of the above scale descriptions. Scores are scaled 0-100, where 0 denotes the lowest reportable health status. Scores of 100 indicate the highest reportable health better outcome status.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Patient's with non missing KCCQ data"}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Procedural Costs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR + Medical Therapy', 'description': 'n=175 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation\n\nTAVR: Transcatheter Aortic Valve Replacement'}, {'id': 'OG001', 'title': 'TAVR + WATCHMAN', 'description': 'n=175 will undergo simultaneous Transcatheter Aortic Valve Replacement (TAVR) with a WATCHMAN device.\n\nWATCHMAN: WATCHMAN Device is composed of a self-expanding nitinol structure with a porous membrane on the proximal face. The implant device is delivered to the Left Atrial Appendage by femoral venous access and transseptal puncture to enter the left atrium.\n\nTAVR: Transcatheter Aortic Valve Replacement'}], 'classes': [{'categories': [{'measurements': [{'value': '195309.64', 'spread': '206704.690', 'groupId': 'OG000'}, {'value': '216020.41', 'spread': '91603.542', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Mean cost during hospitalization up to 40 days.', 'description': 'Procedural costs related to the initial TAVR and WATCHMAN procedures', 'unitOfMeasure': 'dollars', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Sites willing to provide cost data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TAVR + Medical Therapy', 'description': 'n=175 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation\n\nTAVR: Transcatheter Aortic Valve Replacement'}, {'id': 'FG001', 'title': 'TAVR + WATCHMAN', 'description': 'n=175 will undergo simultaneous Transcatheter Aortic Valve Replacement (TAVR) with a WATCHMAN device.\n\nWATCHMAN: WATCHMAN Device is composed of a self-expanding nitinol structure with a porous membrane on the proximal face. The implant device is delivered to the Left Atrial Appendage by femoral venous access and transseptal puncture to enter the left atrium.\n\nTAVR: Transcatheter Aortic Valve Replacement'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Enrollment started December 2017. Last subject enrolled November 2020. Subjects were followed for 24 months from enrollment date. Follow up period ended December 2022.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '172'}, {'groupId': 'FG001', 'numSubjects': '177'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '172'}, {'groupId': 'FG001', 'numSubjects': '177'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'General study population consisted of patients having non-valvular Atrial Fibrillation undergoing standard of care TAVR. Recruitment started December 2017 with the final subject enrolled November 2020. Only medical centers with approval for commercial WATCHMAN implantation were included in this trial. There were 34 North American sites in the WATCH TAVR trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '349', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'TAVR + Medical Therapy', 'description': 'n=175 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation\n\nTAVR: Transcatheter Aortic Valve Replacement'}, {'id': 'BG001', 'title': 'TAVR + WATCHMAN', 'description': 'n=175 will undergo simultaneous Transcatheter Aortic Valve Replacement (TAVR) with a WATCHMAN device.\n\nWATCHMAN: WATCHMAN Device is composed of a self-expanding nitinol structure with a porous membrane on the proximal face. The implant device is delivered to the Left Atrial Appendage by femoral venous access and transseptal puncture to enter the left atrium.\n\nTAVR: Transcatheter Aortic Valve Replacement'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '172', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '349', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '81.5', 'spread': '6.4', 'groupId': 'BG000'}, {'value': '80.8', 'spread': '7.8', 'groupId': 'BG001'}, {'value': '81.1', 'spread': '7.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '167', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '340', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '172', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '349', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants in number'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-09', 'size': 1664081, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-01-09T11:29', 'hasProtocol': True}, {'date': '2023-02-16', 'size': 864514, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-01-09T11:29', 'hasProtocol': False}, {'date': '2020-07-09', 'size': 315962, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-01-09T06:40', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized in a 1:1 allocation ratio to the following treatment arms TAVR + Medical Therapy (n=175) or simultaneous TAVR + WATCHMAN (n=175)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 350}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-19', 'studyFirstSubmitDate': '2017-05-23', 'resultsFirstSubmitDate': '2024-01-11', 'studyFirstSubmitQcDate': '2017-05-31', 'lastUpdatePostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-19', 'studyFirstPostDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cardiovascular Mortality', 'timeFrame': 'Through 2 year post-randomization', 'description': 'Cardiovascular related mortality through 2 year'}, {'measure': 'Thrombus or Embolism', 'timeFrame': 'Through 2 year post-randomization', 'description': 'Incidence of arterial or venous embolism'}, {'measure': 'Re-hospitalization', 'timeFrame': 'Through 2 year post-randomization', 'description': 'Incidence of re-hospitalizations related to the WATCHMAN procedure or WATCHMAN device'}, {'measure': 'Quality of Life Score: KCCQ-12', 'timeFrame': 'Through 2 year post-randomization', 'description': "Change from baseline in quality of life (QoL) as measured using the KCCQ-12 score. Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated tool used to assess heart failure and how it affects the participant's life. Four domain scores and one summary score are generated from the KCCQ-12: Physical Limitation Score, Symptom Frequency Score, Quality of Life Score, Social Limitation Score and a Summary Score. Scale ranges for each question 1 to 6 (Extremely limited 1, Quite a bit limited 2, Moderately limited 3, Slightly limited 4, Not at all limited 5, Limited for other reasons or did not do the activity 6. The Summary score represents an integration of the patient's physical limitation, symptom frequency, quality of life and social limitation. The total score is calculated as the average of the above scale descriptions. Scores are scaled 0-100, where 0 denotes the lowest reportable health status. Scores of 100 indicate the highest reportable health better outcome status."}, {'measure': 'Procedural Costs', 'timeFrame': 'Mean cost during hospitalization up to 40 days.', 'description': 'Procedural costs related to the initial TAVR and WATCHMAN procedures'}], 'primaryOutcomes': [{'measure': 'Composite of All-cause Mortality, Stroke and Bleeding', 'timeFrame': 'Through 2 year post-randomization', 'description': 'First occurrence of all-cause mortality, stroke (ischemic or hemorrhagic), or bleeding (life-threatening and major) events through 2 years post-randomization.'}], 'secondaryOutcomes': [{'measure': 'All-cause Mortality', 'timeFrame': 'Through 2 year post-randomization', 'description': 'All deaths through 2 year'}, {'measure': 'Stroke', 'timeFrame': 'Through 2 year post-randomization', 'description': 'First occurrence of any ischemic or hemorrhagic stroke through 2 year'}, {'measure': 'Bleeding', 'timeFrame': 'Through 2 year post-randomization', 'description': 'First occurrence of any life-threatening or major bleeding through 2 year'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Atrial Fibrillation', 'Aortic Valve Stenosis']}, 'referencesModule': {'references': [{'pmid': '37874908', 'type': 'DERIVED', 'citation': 'Kapadia SR, Krishnaswamy A, Whisenant B, Potluri S, Iyer V, Aragon J, Gideon P, Strote J, Leonardi R, Agarwal H, Larrain G, Sanchez C, Panaich SS, Harvey J, Vahl T, Menon V, Wolski K, Wang Q, Leon MB. Concomitant Left Atrial Appendage Occlusion and Transcatheter Aortic Valve Replacement Among Patients With Atrial Fibrillation. Circulation. 2024 Mar 5;149(10):734-743. doi: 10.1161/CIRCULATIONAHA.123.067312. Epub 2023 Oct 24.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and effectiveness of the left atrial appendage occlusion with WATCHMAN Device in prevention of stroke and bleeding in patients with atrial fibrillation (AF) undergoing transcatheter aortic valve replacement (TAVR).', 'detailedDescription': 'WATCH-TAVR is a prospective, multicenter, randomized controlled trial. Only centers with approval for commercial WATCHMAN implantation will be included in this trial. Subjects will be enrolled at up to 32 centers in the United States. There will be up to 350 subjects enrolled, with 175 patients randomized to TAVR + medical therapy and 175 patients randomized to simultaneous TAVR+WATCHMAN to accumulate the necessary 191 primary events. Enrollment is expected to occur over the course of 18 months. Patients will be followed for a total of 2 years. Patients with non-valvular AF undergoing standard of care commercial TAVR will be enrolled in the trial.\n\nFor patients who receive the WATCHMAN device, plan of care will follow WATCHMAN labeling.Patients randomized to receive the WATCHMAN device will receive anticoagulation with warfarin and aspirin for 6 weeks after the procedure. After 6 weeks, the plan of care will follow WATCHMAN labeling. Patients randomized to the TAVR + medical therapy arm will be treated in accordance with standard of care with either warfarin, other anticoagulant/antiplatelet therapy, or no anticoagulation at the discretion of the treating physician. All patients will continue to receive routine post-TAVR follow-up and care.Patients will be monitored for primary and secondary endpoints as outlined. Baseline information and laboratory data will be collected as described in the protocol.\n\nAt trial conclusion, total number of subjects enrolled was 349. There were 172 subjects enrolled in the TAVR + Medical Therapy arm and 177 subjects enrolled in the TAVR + WATCHMAN arm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Men and women ≥ 18 years of age.\n2. The patient meets criteria for and is scheduled to undergo TAVR procedure\n3. The patient has documented paroxysmal, persistent, or permanent atrial fibrillation.\n4. The patient meets the WATCHMAN labeling guidelines and is eligible to undergo the WATCHMAN implantation procedure.\n5. The patient is eligible for short term warfarin therapy.\n6. The patient or legal representative is able to understand and willing to provide written informed consent to participate in the trial.\n7. The patient is able and willing to return for required follow-up visits and examinations.\n\nExclusion Criteria:\n\n1. The patient had a stroke or TIA within the last 6 months prior to enrollment.\n2. Contraindication for short term anticoagulation.\n\n3 .Moderate or severe Mitral Stenosis with mean gradient across Mitral Valve \\>10 mm Hg or Mitral Valve Area \\< 1.2cm2.\n\n4\\. The patient has symptomatic carotid disease (i.e.,carotid stenosis ≥ 50% associated with ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke within 6 months).\n\n5\\. Prior occlusion of LAA.\n\n6\\. The patient has an implanted mechanical mitral valve.\n\n7\\. The patient requires long-term warfarin therapy due to:\n\n1. Secondary to conditions such as prior arterial embolism or other indications such as pulmonary embolism or deep vein thrombosis within the previous 6 months\n2. The patient is in a hypercoaguable state; exclude the patient if per medical record documentation, the patient meets any of the following criteria:\n\n * Thrombosis occurring ≤ 40 years of age\n * Idiopathic or recurrent VTE (venous thrombo-embolism)\n * Thrombosis at an unusual site (cerebral veins, hepatic veins, renal veins, IVC, mesenteric veins)\n * Family history of VTE or of inherited prothrombotic disorder, recurrence/extension of thrombosis while adequately anticoagulated.\n\n 8\\. The patient is actively enrolled in another trial of a cardiovascular device or an investigational drug (post-market study participation and registries are acceptable).\n\n 9\\. The patient is pregnant or pregnancy is planned during the course of the investigation if patient is of child bearing potential.\n\n 10\\. Any clinically significant medical condition or presence of any laboratory abnormality prior to randomization that is considered by the investigator to be clinically important and could interfere with the conduct of the study or not meeting procedure guidelines for TAVR or WATCHMAN.\n\n 11\\. The patient has a life expectancy of less than two years.'}, 'identificationModule': {'nctId': 'NCT03173534', 'briefTitle': 'WATCH-TAVR, WATCHMAN for Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'WATCHMAN for Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement', 'orgStudyIdInfo': {'id': 'WATCH-TAVR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TAVR + Medical Therapy', 'description': 'n=172 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation', 'interventionNames': ['Device: TAVR']}, {'type': 'EXPERIMENTAL', 'label': 'TAVR + WATCHMAN', 'description': 'n=177 will undergo simultaneous Transcatheter Aortic Valve Replacement (TAVR) with a WATCHMAN device.', 'interventionNames': ['Device: WATCHMAN', 'Device: TAVR']}], 'interventions': [{'name': 'WATCHMAN', 'type': 'DEVICE', 'description': 'WATCHMAN Device is composed of a self-expanding nitinol structure with a porous membrane on the proximal face. The implant device is delivered to the Left Atrial Appendage by femoral venous access and transseptal puncture to enter the left atrium.', 'armGroupLabels': ['TAVR + WATCHMAN']}, {'name': 'TAVR', 'type': 'DEVICE', 'description': 'Transcatheter Aortic Valve Replacement', 'armGroupLabels': ['TAVR + Medical Therapy', 'TAVR + WATCHMAN']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner University Medical Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '94010', 'city': 'Burlingame', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Health/Palo Alto Medical Foundation', 'geoPoint': {'lat': 37.5841, 'lon': -122.36608}}, {'zip': '93105', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'Santa Barbara Cottage Hospital', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '80538', 'city': 'Loveland', 'state': 'Colorado', 'country': 'United States', 'facility': 'UCHealth Medical Center of the Rockies', 'geoPoint': {'lat': 40.39776, 'lon': -105.07498}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Medstar Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Health Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33709', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Northside Hospital', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '32308', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Tallahassee Research Institute', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'zip': '62701', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Prairie 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