Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-03-05 @ 3:31 AM
Study NCT ID:
NCT01824394
Status:
TERMINATED
Last Update Posted:
2025-02-04
First Post:
2013-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Czechia', 'Hungary', 'Italy', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mholden8@its.jnj.com', 'phone': '(949) 923-4700', 'title': 'Megan Holden', 'organization': 'Biosense Webster, Inc.'}, 'certainAgreement': {'otherDetails': "The sponsor can review results communications prior to public release and can embargo communications regarding trial results for 60 to 180 days from the time submitted to the sponsor for review. For multicenter studies, the first results communications should be a joint multicenter publication. PIs may communicate results from their institution as indicated above if a multicenter publication is not submitted by the Sponsor or representatives within 12 months of the study's conclusion.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '3 years post ablation procedures', 'eventGroups': [{'id': 'EG000', 'title': 'nMARQ® Group', 'description': 'Pulmonary vein isolation by radiofrequency ablation treatment with the nMARQ® catheter.', 'otherNumAtRisk': 151, 'deathsNumAtRisk': 151, 'otherNumAffected': 86, 'seriousNumAtRisk': 151, 'deathsNumAffected': 3, 'seriousNumAffected': 38}, {'id': 'EG001', 'title': 'THERMOCOOL® Group', 'description': 'Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® catheter', 'otherNumAtRisk': 149, 'deathsNumAtRisk': 149, 'otherNumAffected': 86, 'seriousNumAtRisk': 149, 'deathsNumAffected': 2, 'seriousNumAffected': 25}, {'id': 'EG002', 'title': 'Roll-in Subjects', 'description': 'Calibration roll-in cohort', 'otherNumAtRisk': 104, 'deathsNumAtRisk': 104, 'otherNumAffected': 74, 'seriousNumAtRisk': 104, 'deathsNumAffected': 4, 'seriousNumAffected': 31}], 'otherEvents': [{'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Vascular pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 8, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Thyroid disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Corneal abrasionCorneal abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Oesophageal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Vessel puncture site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Heart rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 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'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Vascular pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Vessel puncture site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Early Onset Primary Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'nMARQ® Group', 'description': 'Pulmonary vein isolation by radiofrequency ablation treatment with the nMARQ® catheter.'}, {'id': 'OG001', 'title': 'ThermoCool Group', 'description': 'Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® catheter.'}, {'id': 'OG002', 'title': 'Roll-in Subjects', 'description': 'Calibration roll-in cohort'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days post-procedure', 'description': 'The primary safety endpoint was the incidence of early-onset primary adverse events within 7 days post the AF ablation procedure; Pulmonary vein stenosis and atrio-esophageal fistula that occurred beyond 7 days post-procedure and development of a significant pericardial effusion within 30 days post-procedure were also considered primary AEs', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'PRIMARY', 'title': 'Incidence of Early Onset Primary Adverse Events for the Intent-to-Treat and As-Treated Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'nMARQ® Group', 'description': 'Pulmonary vein isolation by radiofrequency ablation treatment with the nMARQ® catheter.'}, {'id': 'OG001', 'title': 'ThermoCool Group', 'description': 'Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® catheter.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days post-procedure', 'description': 'The primary safety endpoint was the incidence of early-onset primary adverse events within 7 days post the AF ablation procedure; Pulmonary vein stenosis and atrio-esophageal fistula that occurred beyond 7 days post-procedure and development of a significant pericardial effusion within 30 days post-procedure were also considered primary AEs', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat and As-Treated population which includes randomized patients who have the ablation catheter inserted'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'nMARQ® Group', 'description': 'Pulmonary vein isolation by radiofrequency ablation treatment with the nMARQ® catheter.'}, {'id': 'FG001', 'title': 'ThermoCool Group', 'description': 'Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® catheter.'}, {'id': 'FG002', 'title': 'Roll-in Subjects', 'description': 'Calibration roll-in cohort'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Patients who signed informed consent forms', 'achievements': [{'groupId': 'FG000', 'numSubjects': '174'}, {'groupId': 'FG001', 'numSubjects': '169'}, {'groupId': 'FG002', 'numSubjects': '125'}]}, {'type': 'Intent to Treat Population', 'comment': 'Intent-to-Treat (ITT) population include randomized patients who have the ablation catheter inserted', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}, {'groupId': 'FG001', 'numSubjects': '149'}, {'comment': 'Calibration Roll-in patients are not included in the ITT', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Safety Population', 'comment': 'Safety Population includes those patients who have the ablation catheter inserted', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}, {'groupId': 'FG001', 'numSubjects': '149'}, {'comment': 'Calibration Roll-in patients are included in the safety population', 'groupId': 'FG002', 'numSubjects': '104'}]}, {'type': 'Per-Protocol Population', 'comment': 'Includes ITT patients who have undergone RF ablation and are in compliance with study protocol', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '148'}, {'comment': 'Calibration Roll-in patients are not included in the per protocol population', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'comment': 'All enrolled subjects who underwent insertion of the study catheter', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '53'}, {'groupId': 'FG002', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '119'}, {'groupId': 'FG001', 'numSubjects': '116'}, {'groupId': 'FG002', 'numSubjects': '74'}]}], 'dropWithdraws': [{'type': 'Early Termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawn due to Study Termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '83'}, {'groupId': 'FG002', 'numSubjects': '41'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Discontinued Subjects', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Excluded Subjects(No catheter inserted)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '21'}]}]}], 'recruitmentDetails': 'The first subject was enrolled on April 1, 2013. Enrollment was terminated on May 25, 2017.', 'preAssignmentDetails': 'This was a prospective, multicenter, randomized, controlled, two arm single-blind design. Enrolled subjects N=481 (subjects signed informed consent) 468 does not include 13 subjects excluded prior to randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'BG000'}, {'value': '169', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}, {'value': '468', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'nMARQ® Group', 'description': 'Pulmonary vein isolation by radiofrequency ablation treatment with the nMARQ® catheter.'}, {'id': 'BG001', 'title': 'THERMOCOOL® Group', 'description': 'Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® catheter.'}, {'id': 'BG002', 'title': 'Roll-in Subjects', 'description': 'Calibration roll-in cohort'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'BG000'}, {'value': '169', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}, {'value': '468', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '62.0', 'spread': '10.81', 'groupId': 'BG000'}, {'value': '61.8', 'spread': '10.40', 'groupId': 'BG001'}, {'value': '63.6', 'spread': '9.96', 'groupId': 'BG002'}, {'value': '62.4', 'spread': '10.41', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only include those enrolled subjects with data available. Enrolled subjects are those who signed informed consent forms.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'BG000'}, {'value': '169', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}, {'value': '468', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '176', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '292', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Enrolled subjects with data available.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}, {'value': '467', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '453', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Enrolled Subjects with data available. 467 does not include 14 subjects; 1 ThermoCool group patient missing data, 9 subjects excluded prior to randomization, 4 excluded subjects missing data.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'BG000'}, {'value': '169', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}, {'value': '468', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Enrolled subjects with data available.'}], 'populationDescription': 'Enrolled subjects N=481 (subjects signed informed consent) 468 does not include 13 subjects; 10 subjects excluded prior to randomization, 3 excluded subjects missing data.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-09-19', 'size': 2184977, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-11-26T14:17', 'hasProtocol': True}, {'date': '2017-12-07', 'size': 834218, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-11-26T14:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 481}}, 'statusModule': {'whyStopped': 'Business Decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2017-11-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2013-04-01', 'resultsFirstSubmitDate': '2018-11-26', 'studyFirstSubmitQcDate': '2013-04-01', 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-26', 'studyFirstPostDateStruct': {'date': '2013-04-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Early Onset Primary Adverse Events', 'timeFrame': '30 days post-procedure', 'description': 'The primary safety endpoint was the incidence of early-onset primary adverse events within 7 days post the AF ablation procedure; Pulmonary vein stenosis and atrio-esophageal fistula that occurred beyond 7 days post-procedure and development of a significant pericardial effusion within 30 days post-procedure were also considered primary AEs'}, {'measure': 'Incidence of Early Onset Primary Adverse Events for the Intent-to-Treat and As-Treated Population', 'timeFrame': '30 days post-procedure', 'description': 'The primary safety endpoint was the incidence of early-onset primary adverse events within 7 days post the AF ablation procedure; Pulmonary vein stenosis and atrio-esophageal fistula that occurred beyond 7 days post-procedure and development of a significant pericardial effusion within 30 days post-procedure were also considered primary AEs'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['nMARQ', 'Atrial Fibrillation', 'Drug Refractory', 'Radio Frequency'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'To demonstrate safety and effectiveness of nMARQ Catheter System \\[nMARQ\\] compared with THERMOCOOL® Navigational Family of catheters in treating subjects with drug-refractory symptomatic paroxysmal atrial fibrillation (PAF).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with symptomatic paroxysmal AF who have had at least one AF episode documented within one (1) year prior to enrollment. Documentation may include ECG, transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip.\n2. Patients who have failed at least one antiarrhythmic drug (AAD; class I or III, or atrioventricular (AV) nodal blocking agents such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic AF, or intolerance to the AAD.\n3. Pre-procedure anticoagulation on warfarin, rivaroxaban, or apixaban.\n4. Age 18 years or older.\n5. Signed Patient Informed Consent Form (ICF).\n6. Able and willing to comply with all pre-, post-, and follow-up testing and requirements.\n\nExclusion Criteria:\n\n1. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.\n2. Previous ablation for atrial fibrillation.\n3. Patients on amiodarone at any time during the past 3 months prior to enrollment.\n4. AF episodes lasting \\> 7 days.\n5. Any cardiac surgery within the past 60 days (2 months).\n6. Any valvular cardiac surgical procedure (i.e., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).\n7. Coronary artery bypass graft (CABG) procedure within the last 180 days (6 months).\n8. Awaiting cardiac transplantation or other cardiac surgery within the next 365 days (12 months).\n9. Documented left atrial thrombus on imaging.\n10. History of a documented thromboembolic event within the past one (1) year.\n11. Diagnosed atrial myxoma.\n12. Presence of implanted cardioverter defibrillator (ICD).\n13. Significant pulmonary disease, (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.\n14. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.\n15. Women who are pregnant (as evidenced by pregnancy test if subject is of child-bearing age and potential) or breast feeding.\n16. Acute illness or active systemic infection or sepsis.\n17. Unstable angina.\n18. Myocardial infarction within the previous 60 days (2 months).\n19. Left ventricular ejection fraction \\<40%.\n20. History of blood clotting or bleeding abnormalities.\n21. Contraindication to anticoagulation (i.e., heparin, dabigatran, Vitamin K Antagonists such as warfarin).\n22. Life expectancy less than 365 days (12 months).\n23. Enrollment in an investigational study evaluating another device or drug.\n24. Uncontrolled heart failure or NYHA Class III or IV heart failure.\n25. Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.\n26. Presence of a condition that precludes vascular access.\n27. Left atrial size \\>50 mm.'}, 'identificationModule': {'nctId': 'NCT01824394', 'briefTitle': 'nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biosense Webster, Inc.'}, 'officialTitle': 'reMARQable nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'reMARQable'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'nMARQ Catheter', 'description': 'nMARQ Catheter System', 'interventionNames': ['Device: nMARQ Navigation Catheters']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NaviStar ThermoCool Catheters', 'description': 'THERMOCOOL® Navigational family of catheters', 'interventionNames': ['Device: NaviStar ThermoCool Catheters']}], 'interventions': [{'name': 'nMARQ Navigation Catheters', 'type': 'DEVICE', 'armGroupLabels': ['nMARQ Catheter']}, {'name': 'NaviStar ThermoCool Catheters', 'type': 'DEVICE', 'armGroupLabels': ['NaviStar ThermoCool Catheters']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biosense Webster, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}