Viewing Study NCT04149535

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Ignite Creation Date: 2025-12-24 @ 10:10 PM
Ignite Modification Date: 2026-02-24 @ 3:13 PM
Study NCT ID: NCT04149535
Status: COMPLETED
Last Update Posted: 2023-02-02
First Post: 2019-10-31
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sarah.zanon@bsci.com', 'phone': '+41798407006', 'title': 'Sarah Zanon - Director Clinical Trials, Interventional Cardiology', 'organization': 'Boston Scientific'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke.', 'description': 'All SAE, ADE, SADE, UADE, USADE, device deficiencies, and CEC events were reported to BSC.', 'eventGroups': [{'id': 'EG000', 'title': 'TAVR With Sentinel', 'description': 'Patients assigned to this group will undergo TAVR with the Sentinel® Cerebral Protection System.\n\nSentinel® Cerebral Protection System: cerebral embolic protection system', 'otherNumAtRisk': 1501, 'deathsNumAtRisk': 1501, 'otherNumAffected': 0, 'seriousNumAtRisk': 1501, 'deathsNumAffected': 11, 'seriousNumAffected': 285}, {'id': 'EG001', 'title': 'TAVR Without Sentinel', 'description': 'Patients assigned to this group will undergo TAVR without the Sentinel® Cerebral Protection System.', 'otherNumAtRisk': 1499, 'deathsNumAtRisk': 1499, 'otherNumAffected': 0, 'seriousNumAtRisk': 1499, 'deathsNumAffected': 7, 'seriousNumAffected': 315}], 'seriousEvents': [{'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 92}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 29}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 14}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cardiac tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bundle branch block right', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bradyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nodal arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nodal rhythm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pericardial haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Prosthetic cardiac valve thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Right ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Atrial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bundle branch block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Chronic left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Coronary artery insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Defect conduction intraventricular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Myocardial haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Myocardial rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pulseless electrical activity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Right ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Tachyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Torsade de pointes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Embolic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cerebellar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cerebellar stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Haemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Lacunar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Lumbar radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vascular procedure complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 15}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vascular pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 11}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Postoperative delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vascular access site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Aortic annulus rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cardiac valve replacement complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Aortic pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Arterial injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cardiac procedure complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Device deployment issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Femoral nerve injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Iatrogenic injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Post procedural fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Postoperative ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Postoperative respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Traumatic haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Arterial haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Peripheral artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Aortic intramural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Aortic rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Iliac artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Aortic arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Arteriovenous fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Haemodynamic instability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypertensive urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypoperfusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Catheter site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Catheter site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Device embolisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Calcinosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 10}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pulmonary congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Blood loss anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Microcytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Device failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Device leakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Device malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Lead dislodgement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Corona virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Urinary tract infection enterococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Retroperitoneal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Iron deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cardiovascular function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Electrocardiogram QRS complex prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Troponin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Retinal artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Liver disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Compartment syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1499, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1501', 'groupId': 'OG000'}, {'value': '1499', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR With Sentinel', 'description': 'Patients assigned to this group will undergo TAVR with the Sentinel® Cerebral Protection System.\n\nSentinel® Cerebral Protection System: cerebral embolic protection system'}, {'id': 'OG001', 'title': 'TAVR Without Sentinel', 'description': 'Patients assigned to this group will undergo TAVR without the Sentinel® Cerebral Protection System.'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '<=72 hours', 'description': 'All stroke (hemorrhagic, ischemic, or undetermined status; disabling or nondisabling) through 72 hours post TAVR procedure or discharge (whichever comes first), as adjudicated by an independent Clinical Events Committee (CEC) and using Neurologic Academic Research Consortium (NeuroARC) definitions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TAVR With Sentinel', 'description': 'Patients assigned to this group will undergo TAVR with the Sentinel® Cerebral Protection System.\n\nSentinel® Cerebral Protection System: cerebral embolic protection system'}, {'id': 'FG001', 'title': 'TAVR Without Sentinel', 'description': 'Patients assigned to this group will undergo TAVR without the Sentinel® Cerebral Protection System.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1501'}, {'groupId': 'FG001', 'numSubjects': '1499'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1472'}, {'groupId': 'FG001', 'numSubjects': '1481'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Not described', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1501', 'groupId': 'BG000'}, {'value': '1499', 'groupId': 'BG001'}, {'value': '3000', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'TAVR With Sentinel', 'description': 'Patients assigned to this group will undergo TAVR with the Sentinel® Cerebral Protection System.\n\nSentinel® Cerebral Protection System: cerebral embolic protection system'}, {'id': 'BG001', 'title': 'TAVR Without Sentinel', 'description': 'Patients assigned to this group will undergo TAVR without the Sentinel® Cerebral Protection System.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1501', 'groupId': 'BG000'}, {'value': '1499', 'groupId': 'BG001'}, {'value': '3000', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '78.9', 'spread': '8.0', 'groupId': 'BG000'}, {'value': '78.9', 'spread': '7.8', 'groupId': 'BG001'}, {'value': '78.9', 'spread': '7.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1501', 'groupId': 'BG000'}, {'value': '1499', 'groupId': 'BG001'}, {'value': '3000', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '631', 'groupId': 'BG000'}, {'value': '566', 'groupId': 'BG001'}, {'value': '1197', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '870', 'groupId': 'BG000'}, {'value': '933', 'groupId': 'BG001'}, {'value': '1803', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'denoms': [{'units': 'Participants', 'counts': [{'value': '961', 'groupId': 'BG000'}, {'value': '963', 'groupId': 'BG001'}, {'value': '1924', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '961', 'groupId': 'BG000'}, {'value': '963', 'groupId': 'BG001'}, {'value': '1924', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Black or African Heritage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '961', 'groupId': 'BG000'}, {'value': '963', 'groupId': 'BG001'}, {'value': '1924', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}, {'title': 'Caucasian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '961', 'groupId': 'BG000'}, {'value': '963', 'groupId': 'BG001'}, {'value': '1924', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '852', 'groupId': 'BG000'}, {'value': '872', 'groupId': 'BG001'}, {'value': '1724', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'denoms': [{'units': 'Participants', 'counts': [{'value': '961', 'groupId': 'BG000'}, {'value': '963', 'groupId': 'BG001'}, {'value': '1924', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'denoms': [{'units': 'Participants', 'counts': [{'value': '961', 'groupId': 'BG000'}, {'value': '963', 'groupId': 'BG001'}, {'value': '1924', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '961', 'groupId': 'BG000'}, {'value': '963', 'groupId': 'BG001'}, {'value': '1924', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'Not Disclosed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '961', 'groupId': 'BG000'}, {'value': '963', 'groupId': 'BG001'}, {'value': '1924', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data not collected on patients from EU.'}, {'title': 'Surgical Risk (Per Heart Team): Extreme/High Risk', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1501', 'groupId': 'BG000'}, {'value': '1499', 'groupId': 'BG001'}, {'value': '3000', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '457', 'groupId': 'BG000'}, {'value': '456', 'groupId': 'BG001'}, {'value': '913', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Risk of Mortality based on site specific Heart Team evaluation. There is not a defined scale.', 'unitOfMeasure': 'Participants'}, {'title': 'Surgical Risk (Per Heart Team): Intermediate Risk', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1501', 'groupId': 'BG000'}, {'value': '1499', 'groupId': 'BG001'}, {'value': '3000', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '499', 'groupId': 'BG000'}, {'value': '512', 'groupId': 'BG001'}, {'value': '1011', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Risk of Mortality based on site specific Heart Team evaluation. There is not a defined scale.', 'unitOfMeasure': 'Participants'}, {'title': 'Surgical Risk (Per Heart Team): Low Risk', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1501', 'groupId': 'BG000'}, {'value': '1499', 'groupId': 'BG001'}, {'value': '3000', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '545', 'groupId': 'BG000'}, {'value': '531', 'groupId': 'BG001'}, {'value': '1076', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Risk of Mortality based on site specific Heart Team evaluation. There is not a defined scale.', 'unitOfMeasure': 'Participants'}, {'title': 'Native/Non-Native Valve Calcification Severity (site reported): None/Mild', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1501', 'groupId': 'BG000'}, {'value': '1499', 'groupId': 'BG001'}, {'value': '3000', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '241', 'groupId': 'BG000'}, {'value': '223', 'groupId': 'BG001'}, {'value': '464', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Native/Non-Native Valve Calcification Severity (site reported): Moderate', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1501', 'groupId': 'BG000'}, {'value': '1499', 'groupId': 'BG001'}, {'value': '3000', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '418', 'groupId': 'BG000'}, {'value': '426', 'groupId': 'BG001'}, {'value': '844', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Native/Non-Native Calcification Severity (site reported): Severe/Extreme', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1501', 'groupId': 'BG000'}, {'value': '1499', 'groupId': 'BG001'}, {'value': '3000', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '773', 'groupId': 'BG000'}, {'value': '792', 'groupId': 'BG001'}, {'value': '1565', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-11-06', 'size': 1185649, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-10-26T16:51', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-17', 'studyFirstSubmitDate': '2019-10-31', 'resultsFirstSubmitDate': '2022-11-18', 'studyFirstSubmitQcDate': '2019-10-31', 'lastUpdatePostDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-17', 'studyFirstPostDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First)', 'timeFrame': '<=72 hours', 'description': 'All stroke (hemorrhagic, ischemic, or undetermined status; disabling or nondisabling) through 72 hours post TAVR procedure or discharge (whichever comes first), as adjudicated by an independent Clinical Events Committee (CEC) and using Neurologic Academic Research Consortium (NeuroARC) definitions.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '39471309', 'type': 'DERIVED', 'citation': 'Makkar RR, Gupta A, Waggoner TE, Horr S, Karha J, Satler L, Stoler RC, Alvarez J, Sakhuja R, MacDonald L, Modolo R, Leon MB, Linke A, Kapadia SR. Cerebral Embolic Protection by Geographic Region: A Post Hoc Analysis of the PROTECTED TAVR Randomized Clinical Trial. JAMA Cardiol. 2025 Jan 1;10(1):17-24. doi: 10.1001/jamacardio.2024.4278.'}, {'pmid': '36121045', 'type': 'DERIVED', 'citation': 'Kapadia SR, Makkar R, Leon M, Abdel-Wahab M, Waggoner T, Massberg S, Rottbauer W, Horr S, Sondergaard L, Karha J, Gooley R, Satler L, Stoler RC, Messe SR, Baron SJ, Seeger J, Kodali S, Krishnaswamy A, Thourani VH, Harrington K, Pocock S, Modolo R, Allocco DJ, Meredith IT, Linke A; PROTECTED TAVR Investigators. Cerebral Embolic Protection during Transcatheter Aortic-Valve Replacement. N Engl J Med. 2022 Oct 6;387(14):1253-1263. doi: 10.1056/NEJMoa2204961. Epub 2022 Sep 17.'}]}, 'descriptionModule': {'briefSummary': 'To demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the risk of peri-procedural stroke (≤72 hours) after transcatheter aortic valve replacement (TAVR).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject has documented aortic valve stenosis and is treated with an approved TAVR device via transfemoral access\n* Subject has the recommended artery diameter at the site of filter placement per the Sentinel® Cerebral Protection System Instructions For Use: 9-15 mm for the brachiocephalic artery and 6.5-10 mm in the left common carotid artery.\n* Subject (or legal representative) provides written informed consent.\n\nExclusion Criteria:\n\n* Subject has arterial stenosis \\>70% in either the left common carotid artery or the brachiocephalic artery.\n* Subject's brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm of the aortic ostium.\n* Subject has compromised blood flow to the right upper extremity.\n* Subject has access vessels with excessive tortuosity.\n* Subject has uncorrected bleeding disorders.\n* Subject is contraindicated for anticoagulant and antiplatelet therapy."}, 'identificationModule': {'nctId': 'NCT04149535', 'acronym': 'PROTECTED TAVR', 'briefTitle': 'PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter', 'orgStudyIdInfo': {'id': 'S2453'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAVR with Sentinel', 'description': 'Patients assigned to this group will undergo TAVR with the Sentinel® Cerebral Protection System.', 'interventionNames': ['Device: Sentinel® Cerebral Protection System']}, {'type': 'NO_INTERVENTION', 'label': 'TAVR without Sentinel', 'description': 'Patients assigned to this group will undergo TAVR without the Sentinel® Cerebral Protection System.'}], 'interventions': [{'name': 'Sentinel® Cerebral Protection System', 'type': 'DEVICE', 'description': 'cerebral embolic protection system', 'armGroupLabels': ['TAVR with Sentinel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Tucson Medical Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94118', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Foundation Hospital - San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '91360', 'city': 'Thousand Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Los Robles Regional Medical Center', 'geoPoint': {'lat': 34.17056, 'lon': -118.83759}}, {'zip': '80120', 'city': 'Littleton', 'state': 'Colorado', 'country': 'United States', 'facility': 'South Denver Cardiology Associates PC and Swedish medical center', 'geoPoint': {'lat': 39.61332, 'lon': -105.01665}}, {'zip': '06102', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'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': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Intercoastal Medical Group', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa General Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Hosptial', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Wellstar', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '62701', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'St. Johns Hospital', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '46321', 'city': 'Munster', 'state': 'Indiana', 'country': 'United States', 'facility': 'Community Munster', 'geoPoint': {'lat': 41.56448, 'lon': -87.51254}}, {'zip': '50314', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Mercy Hospital Medical Center', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01805', 'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lahey Clinic Hospital', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'zip': '48912', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Sparrow Hospital', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Abbott Northwestern Hospital', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '64132', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Medical Center', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '68124', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Creighton - Bergan Cardiology', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '07631', 'city': 'Englewood', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Englewood Medical Center', 'geoPoint': {'lat': 40.89288, 'lon': -73.97264}}, {'zip': '98374', 'city': 'Neptune City', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Jersey Shore University Medical Center', 'geoPoint': {'lat': 40.20011, 'lon': -74.02792}}, {'zip': '14213', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Kaleida Health', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore University Hospital', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '11501', 'city': 'Mineola', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Winthrop', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University School of Medicine', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health Sciences University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19096', 'city': 'Wynnewood', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lankenau', 'geoPoint': {'lat': 40.00289, 'lon': -75.27074}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Baptist Memorial', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Centennial Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37323', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Heart Hospital of Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75226', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Heart and Vascular', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'The Heart Hospital Baylor Plano', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '78665', 'city': 'Round Rock', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Scott and White', 'geoPoint': {'lat': 30.50826, 'lon': -97.6789}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Methodist Healthcare System of San Antonio dba Methodist Hospital', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '53215', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Aurora St. Luke's Medical Center", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '3168', 'city': 'Clayton', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Monash Medical Center', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'zip': '4032', 'city': 'Chermside', 'country': 'Australia', 'facility': 'The Prince Charles Hospital', 'geoPoint': {'lat': -27.38472, 'lon': 153.03062}}, {'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': 'DK-8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '13005', 'city': 'Marseille', 'country': 'France', 'facility': 'CHU La Timone Hospital', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '31076', 'city': 'Toulouse', 'country': 'France', 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '23795', 'city': 'Bad Segeberg', 'country': 'Germany', 'facility': 'Heart Center Leipzig', 'geoPoint': {'lat': 53.93775, 'lon': 10.30745}}, {'zip': 'D-01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Herzzentrum Dresden GmbH', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'University Hospital Frankfurt', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': 'D-23538', 'city': 'Lübeck', 'country': 'Germany', 'facility': 'Universitaetsklinikum Schleswig-Holstein', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '81377', 'city': 'Münich', 'country': 'Germany', 'facility': 'LMU Klinikum der Universität München'}, {'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Universitaetsklinikum Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '20097', 'city': 'San Donato', 'state': 'Milanese', 'country': 'Italy', 'facility': 'Policlinico San Donato', 'geoPoint': {'lat': 45.08201, 'lon': 7.66485}}, {'zip': '48010', 'city': 'Cotignola', 'country': 'Italy', 'facility': 'Maria Cecilia Hospital SPA', 'geoPoint': {'lat': 44.38572, 'lon': 11.93852}}, {'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'Fondazione Centro San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Samir Kapadia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}