Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-02-20 @ 11:49 PM
Study NCT ID:
NCT01687166
Status:
COMPLETED
Last Update Posted:
2018-11-21
First Post:
2012-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'weismanm@bsci.com', 'phone': '617-218-3849', 'title': 'Clinical Trial Manager', 'organization': 'Boston Scientific'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from enrollment to end of follow-up ~12Months.', 'description': 'Adverse event data is reported for treatment and attempt subjects.', 'eventGroups': [{'id': 'EG000', 'title': 'Blazer Open-Irrigated Ablation Catheter Randomized', 'description': 'Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system\n\nBlazer Open-Irrigated Ablation Catheter (Boston Scientific)', 'otherNumAtRisk': 159, 'deathsNumAtRisk': 159, 'otherNumAffected': 104, 'seriousNumAtRisk': 159, 'deathsNumAffected': 1, 'seriousNumAffected': 66}, {'id': 'EG001', 'title': 'FDA Approved Open-Irrigated Ablation Catheter Randomized', 'description': 'FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.\n\nFDA Approved Open-Irrigated Ablation Catheter', 'otherNumAtRisk': 167, 'deathsNumAtRisk': 167, 'otherNumAffected': 95, 'seriousNumAtRisk': 167, 'deathsNumAffected': 1, 'seriousNumAffected': 65}, {'id': 'EG002', 'title': 'Blazer Open-Irrigated Ablation Catheter Roll-In', 'description': 'Roll-In Cases for Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system\n\nBlazer Open-Irrigated Ablation Catheter (Boston Scientific)', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 33, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 19}, {'id': 'EG003', 'title': 'FDA Approved Open-Irrigated Ablation Catheter Roll-In', 'description': 'Roll-In Cases for FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.\n\nFDA Approved Open-Irrigated Ablation Catheter', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': '1st degree AV block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': '2nd degree AV block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AV Fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal laboratory values', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Adverse medication reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergic reaction (Ablation Procedure)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anesthesia/Sedation related complication (Ablation Procedure)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aortic root atheromatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arrhythmia (Ablation Procedure)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arterial/Venous Thromboembolic Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation (AF)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 33, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial flutter (type 1 Isthmus Dependent)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atypical Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradycardia with pauses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Breathing difficulties', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Brugada syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain - Ischemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cyst on ascending aorta', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Difficulty sleeping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea on exertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema (Ablation Procedure)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Endocrine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Exacerbation of existing condition (Ablation Procedure)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fluid retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroparesis (Ablation Procedure)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Genitourinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Groin bleed (Ablation Procedure)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Groin pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 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approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.\n\nFDA Approved Open-Irrigated Ablation Catheter'}], 'classes': [{'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Months', 'description': 'The safety of the Blazer OI catheter will be evaluated by demonstrating that the investigational group serious adverse event rate is non-inferior to that of the control group.\n\nThe safety of the Blazer OI catheter will be evaluated by demonstrating that the investigational group rate of significant pulmonary vein stenosis (≥70% reduction in diameter from baseline) and atrio-esophageal fistulas is non-inferior to that of the control group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome Measures were not assessed for the non-randomized participants.'}, {'type': 'PRIMARY', 'title': 'Chronic Success Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blazer Open-Irrigated Ablation Catheter', 'description': 'Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system\n\nBlazer Open-Irrigated Ablation Catheter (Boston Scientific)'}, {'id': 'OG001', 'title': 'Control', 'description': 'FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.\n\nFDA Approved Open-Irrigated Ablation Catheter'}], 'classes': [{'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 12 months of the index procedure', 'description': 'The primary effectiveness of the Blazer OI catheter will be evaluated by demonstrating that the proportion of subjects free from failure\\* in the investigational group is non-inferior to those in the control group.\n\n\\*failure is defined as a randomized subject being an acute procedural failure, having more than one repeat procedure during the 90 day blanking period or having a documented symptomatic atrial fibrillation, atrial tachycardia, atrial fibrillation between 91 days and 12 months post-procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome Measures were not assessed for the non-randomized participants.'}, {'type': 'SECONDARY', 'title': 'Acute Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blazer Open-Irrigated Ablation Catheter', 'description': 'Blazer Open-Irrigated 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Acute procedural success is defined as a subject that successfully had all clinically relevant veins electrically isolated, by demonstration of entrance block at a minimum and no evidence of exit conduction with the randomized investigational or control catheter only.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome Measures were not assessed for the non-randomized participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Blazer Open-Irrigated Ablation Catheter', 'description': 'Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system\n\nBlazer Open-Irrigated Ablation Catheter (Boston Scientific)'}, {'id': 'FG001', 'title': 'Control', 'description': 'FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.\n\nFDA Approved 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'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Subject moved out of state', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Patient unable to be compliant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician choice to use different device', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Insurance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 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'description': 'Blazer Open-Irrigated Ablation Catheter Roll-In Subjects (Not randomized)'}, {'id': 'BG003', 'title': 'Control Roll-In', 'description': 'Non-Randomized Subjects treated with an FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.\n\nFDA Approved Open-Irrigated Ablation Catheter'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60', 'spread': '11', 'groupId': 'BG000'}, {'value': '59', 'spread': '10', 'groupId': 'BG001'}, {'value': '62', 'spread': '10', 'groupId': 'BG002'}, {'value': '61', 'spread': '10', 'groupId': 'BG003'}, {'value': '60', 'spread': '11', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '143', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '255', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Sweden', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '267', 'groupId': 'BG004'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}, {'title': 'Portugal', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '59', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '173', 'spread': '9', 'groupId': 'BG000'}, {'value': '174', 'spread': '9', 'groupId': 'BG001'}, {'value': '175', 'spread': '11', 'groupId': 'BG002'}, {'value': '175', 'spread': '11', 'groupId': 'BG003'}, {'value': '174', 'spread': '10', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '89', 'spread': '19', 'groupId': 'BG000'}, {'value': '90', 'spread': '22', 'groupId': 'BG001'}, {'value': '94', 'spread': '21', 'groupId': 'BG002'}, {'value': '79', 'spread': '15', 'groupId': 'BG003'}, {'value': '90', 'spread': '21', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Resting Heart Rate', 'classes': [{'categories': [{'measurements': [{'value': '71', 'spread': '19', 'groupId': 'BG000'}, {'value': '67', 'spread': '15', 'groupId': 'BG001'}, {'value': '68', 'spread': '17', 'groupId': 'BG002'}, {'value': '68', 'spread': '7', 'groupId': 'BG003'}, {'value': '69', 'spread': '17', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'bpm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'New York Heart Assessment (NYHA) Class', 'classes': [{'title': 'I', 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '154', 'groupId': 'BG004'}]}]}, {'title': 'II', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}]}, {'title': 'Non Heart Failure (HF)', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '192', 'groupId': 'BG004'}]}]}, {'title': 'Not Assessed', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'NYHA Class at enrollment based upon the following definitions:\n\nClass I - Subjects with heart disease who are able to remain at a comfortable state while performing ordinary physical activity Class II - Subjects who are comfortable at rest or with mild exertion but experience symptoms with more strenuous activity Class III - Subjects who are comfortable at rest but experience symptoms with mild activity Class IV - Subjects who are symptomatic at rest and are unable to carry out any physical activity', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 398}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-24', 'studyFirstSubmitDate': '2012-08-29', 'resultsFirstSubmitDate': '2018-02-15', 'studyFirstSubmitQcDate': '2012-09-13', 'lastUpdatePostDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-15', 'studyFirstPostDateStruct': {'date': '2012-09-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedure-related Complication Free Rate', 'timeFrame': '12 Months', 'description': 'The safety of the Blazer OI catheter will be evaluated by demonstrating that the investigational group serious adverse event rate is non-inferior to that of the control group.\n\nThe safety of the Blazer OI catheter will be evaluated by demonstrating that the investigational group rate of significant pulmonary vein stenosis (≥70% reduction in diameter from baseline) and atrio-esophageal fistulas is non-inferior to that of the control group.'}, {'measure': 'Chronic Success Rate', 'timeFrame': 'Within 12 months of the index procedure', 'description': 'The primary effectiveness of the Blazer OI catheter will be evaluated by demonstrating that the proportion of subjects free from failure\\* in the investigational group is non-inferior to those in the control group.\n\n\\*failure is defined as a randomized subject being an acute procedural failure, having more than one repeat procedure during the 90 day blanking period or having a documented symptomatic atrial fibrillation, atrial tachycardia, atrial fibrillation between 91 days and 12 months post-procedure.'}], 'secondaryOutcomes': [{'measure': 'Acute Success', 'timeFrame': 'Acute- During Index Procedure, 20 minutes after confirmation of Pulmonary Vein Isolation', 'description': 'Demonstration that the investigational group acute procedural success rate is non-inferior to that of the control group. Acute procedural success is defined as a subject that successfully had all clinically relevant veins electrically isolated, by demonstration of entrance block at a minimum and no evidence of exit conduction with the randomized investigational or control catheter only.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Paroxysmal Atrial Fibrillation', 'Cardiac Arrhythmias', 'Heart Disease', 'Cardiovascular Disease', 'Radiofrequency Ablation'], 'conditions': ['Paroxysmal Atrial Fibrillation (PAF)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to establish the safety and effectiveness of the Blazer Open-Irrigated radiofrequency ablation catheter for the treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.', 'detailedDescription': 'The ZERO-AF trial is a prospective, multicenter, single blind, 1:1 randomized study. The trial is designed to demonstrate that the safety and effectiveness of the Blazer® Open-Irrigated Ablation Catheter are non-inferior to the safety and effectiveness of the control catheters, for the treatment drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation. The control catheters are open-irrigated radiofrequency ablation catheters that are approved in the United States for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of recurrent symptomatic PAF with ≥2 episodes reported within the 365 days prior to enrollment\n\n o PAF is AF episodes that last ≥30 seconds in duration and terminate within 7 days.\n* At least 1 episode of PAF documented by Holter monitor, rhythm strip, trans-telephonic monitor (TTM), or 12-lead ECG in the 365 days prior to enrollment\n* Refractory to at least one Beta Blocker, Calcium Channel Blocker, Class I OR Class III anti-arrhythmic drug (AAD)\n* Age 18 or above, or of legal age to give informed consent specific to state and national law\n* Competent and willing to provide written informed consent to participate in the study and agree to comply with follow-up visits and evaluation\n\nExclusion Criteria:\n\n* Have any of the following heart conditions within 90 days prior to enrollment:\n\n * New York Heart Association (NYHA) Class III or IV\n * Left ventricular ejection fraction (LVEF) \\<35%\n * Left atrial (LA) diameter \\>5.5 cm\n * Unstable angina or ongoing myocardial ischemia\n * Transmural myocardial infarction (MI)\n* Congenital structural heart disease that increases the risk of ablation or precludes catheter placement\n* Undergone any left atrial catheter or surgical ablation\n* Have had a coronary intervention, cardiac surgery, or other cardiac ablation within 90 days prior to enrollment\n* Had \\>1 AF episode lasting greater than 7 days, with no episodes having lasted greater than 30 days, within the past year\n* Subjects regularly prescribed amiodarone therapy during the 120 days prior to enrollment\n* Contraindication to anticoagulation therapy\n* Creatinine \\>2.5mg/dl or creatinine clearance \\<30mL/min within 90 days (3 months) prior to enrollment\n* Prosthetic mitral or tricuspid heart valves\n* Confirmed cardiac thrombus within 30 days (1 month) prior to enrollment\n* Implanted pacemaker, ICD, or CRT leads within 180 days (6 months) prior to enrollment\n* History of CVA, TIA or PE within 180 days (6 months) prior to enrollment\n* Left atrial appendage closure device\n* Any other significant uncontrolled or unstable medical condition (e.g. sepsis, acute metabolic illness, end stage COPD)\n* Enrolled in any concurrent clinical trial without documented pre-approval from BSC\n* Women who are pregnant or plan to become pregnant within the course of their participation in the investigation\n* Life expectancy ≤ 2 years (730 days) per physician opinion'}, 'identificationModule': {'nctId': 'NCT01687166', 'acronym': 'ZERO-AF', 'briefTitle': 'Clinical Evaluation of 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