Viewing Study NCT01639495

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Ignite Creation Date: 2025-12-24 @ 1:35 PM
Ignite Modification Date: 2025-12-30 @ 3:14 PM
Study NCT ID: NCT01639495
Status: COMPLETED
Last Update Posted: 2018-05-15
First Post: 2012-07-10
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation CONTINUED ACCESS
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'rstagg@its.jnj.com', 'phone': '(949) 450-7779', 'title': 'Robert Stagg, PhD, Manager, Clinical Franchise', 'organization': 'Biosense Webster, Inc.'}, 'certainAgreement': {'otherDetails': "There IS an agreement between the Principal Investigator (PI)/Institution and the Sponsor (or its agents) that restricts the PI's rights to discuss, present or publish trial results after the trial is completed. Please contact Biosense Webster, Inc. for additional information.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 months post procedure', 'eventGroups': [{'id': 'EG000', 'title': 'THERMOCOOL® SMARTTOUCH™ Catheter', 'description': 'THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation', 'otherNumAtRisk': 144, 'otherNumAffected': 40, 'seriousNumAtRisk': 144, 'seriousNumAffected': 46}], 'otherEvents': [{'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Arteriovenous fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 32, 'numAffected': 19}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Arrhythmia', 'notes': 'Subjects experienced this serious adervse event required in-patient hospitalization or prolongation of existing hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 26, 'numAffected': 16}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Atrial fibrillation', 'notes': 'Subjects experienced this serious adverse event required in-patient hospitalization or prolongation of existing hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Mitral valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Oesophageal rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Retroperitoneal haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Vascular pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Arteriovenous fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects Achieved Freedom From Atrial Tachyarrhythmias', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'THERMOCOOL® SMARTTOUCH™ Catheter', 'description': 'THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation'}], 'classes': [{'title': 'Primary Effectiveness Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '60.6', 'groupId': 'OG000', 'lowerLimit': '51.9', 'upperLimit': '68.8'}]}]}, {'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '60.8', 'groupId': 'OG000', 'lowerLimit': '50.4', 'upperLimit': '70.6'}]}]}, {'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000', 'lowerLimit': '43.3', 'upperLimit': '75.1'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Percentage of subjects', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '60.6', 'ciLowerLimit': '51.9', 'ciUpperLimit': '68.8', 'estimateComment': 'The 2-sided 95% confidence intervals are based on exact binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 91-361', 'description': 'Freedom from documented symptomatic atrial fibrillation/atrial tachycardia/atrial flutter (hereinafter collectively referred to as "atrial tachyarrhythmias") based on electrocardiographic data during the effectiveness evaluation period (Day 91-361). Acute procedure failures, antiarrhythmic drug(AAD) changes and repeat ablation occurring during evaluation period were deemed as primary effectiveness failures', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '137 Study-eligible subjects with per-protocol procedure. CENSORED: 1 lost to follow-up subject without recurrence'}, {'type': 'SECONDARY', 'title': 'Peri-procedural Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'THERMOCOOL® SMARTTOUCH™ Catheter', 'description': 'THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation'}], 'classes': [{'title': 'Number of subjects had peri-procedural SAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Possibly procedure related', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Not-related to procedure or device', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 8-30 days post procedure', 'description': 'Peri-procedural serious adverse events (SAEs) are those non-primary SAEs occurred within 8-30 days post procedure', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety cohort, including Enrolled subjects who underwent insertion of the study catheter.'}, {'type': 'PRIMARY', 'title': 'Incidence of Primary Adverse Events Within Specified Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'THERMOCOOL® SMARTTOUCH™ Catheter', 'description': 'THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation'}], 'classes': [{'title': 'Primary Safety Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000', 'lowerLimit': '11.6', 'upperLimit': '24.6'}]}]}, {'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000', 'lowerLimit': '7.7', 'upperLimit': '22.0'}]}]}, {'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26.2', 'groupId': 'OG000', 'lowerLimit': '13.9', 'upperLimit': '42.0'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Percentage of subjects with primary AEs', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.4', 'ciLowerLimit': '11.6', 'ciUpperLimit': '24.6', 'estimateComment': 'The 2-sided 95% confidence interval is exact binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 months post procedure', 'description': 'Primary safety endpoint consists of primary adverse events (AE) within 7 days post procedure Or pulmonary vein stenosis and atrio-esophageal fistula events that occurred within 12 months post-procedure. Primary adverse events include death, myocardial infarction, pulmonary vein stenosis, diaphragmatic paralysis, atrio-esophageal fistula, transient ischemic attack, stroke / cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade, pericardial effusion, pneumothorax, atrial perforation, vascular access complications, pulmonary edema, initial and prolonged hospitalization (excluding those due to pre-existing arrhythmia recurrence), heart block.', 'unitOfMeasure': 'percentage of subjects with primary AE', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '144 subjects that had study catheter inserted into their body; INCLUDES study ineligible \\& untreated subjects'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieved Acute Effectiveness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'THERMOCOOL® SMARTTOUCH™ Catheter', 'description': 'THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation'}], 'classes': [{'categories': [{'measurements': [{'value': '97.2', 'groupId': 'OG000', 'lowerLimit': '95.6', 'upperLimit': '98.2'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Percentage of subjects', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '97.2', 'ciLowerLimit': '95.6', 'ciUpperLimit': '98.2', 'estimateComment': 'The 2-sided 95% confidence intervals are exact binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '5 hours of procedure time', 'description': 'Acute effectivenesss is defined as confirmation of entrance block into all Pulmonary veins', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Effectiveness cohort, defined as those enrolled subjects who underwent insertion of the study catheter and an AF ablation procedure. Subjects without RF energy delivery will be excluded (i.e. discontinued subjects).'}, {'type': 'SECONDARY', 'title': 'Late Onset Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'THERMOCOOL® SMARTTOUCH™ Catheter', 'description': 'THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation'}], 'classes': [{'title': 'Number of subjects had late onset SAEs', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Procedure related', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Not-related to procedure or device', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From 31 days post procedure to month 12', 'description': 'Late onset serious adverse events (SAEs) are those non-primary SAEs occurred after 31 days post procedure', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety cohort, including Enrolled subjects who underwent insertion of the study catheter.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'THERMOCOOL® SMARTTOUCH™ Catheter', 'description': 'THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Patients who signed the informed consent.', 'groupId': 'FG000', 'numSubjects': '148'}]}, {'type': 'Safety Cohort', 'comment': 'Safety population includes those enrolled subjects who underwent insertion of the study catheter.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '144'}]}, {'type': 'Primary Effectiveness Cohort', 'comment': 'Safety cohort subjects meeting eligibility criteria \\& receiving radiofrequency (RF) ablation for AF', 'achievements': [{'groupId': 'FG000', 'numSubjects': '138'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': "Consented but didn't have study catheter", 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Not meeting inclusion/exclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'No radiofrequency energy applied', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': "This study enrolled 148 subjects at 15 clinical sites in the U.S. over the course of approximately 8 months. The first subject was enrolled on July 26, 2012, and the last subject was enrolled on March 18, 2013. The study's last index ablation procedure was on April 24, 2013."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'THERMOCOOL® SMARTTOUCH™ Catheter', 'description': 'THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.1', 'spread': '10.36', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '105', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'All subjects who signed informed consent.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '146', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'All subjects who signed informed consent.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '147', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '148', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All subjects who signed informed consent.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This study had a single arm: catheter ablation for PAF'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2014-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-16', 'studyFirstSubmitDate': '2012-07-10', 'resultsFirstSubmitDate': '2017-09-29', 'studyFirstSubmitQcDate': '2012-07-10', 'lastUpdatePostDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-16', 'studyFirstPostDateStruct': {'date': '2012-07-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects Achieved Freedom From Atrial Tachyarrhythmias', 'timeFrame': 'Day 91-361', 'description': 'Freedom from documented symptomatic atrial fibrillation/atrial tachycardia/atrial flutter (hereinafter collectively referred to as "atrial tachyarrhythmias") based on electrocardiographic data during the effectiveness evaluation period (Day 91-361). Acute procedure failures, antiarrhythmic drug(AAD) changes and repeat ablation occurring during evaluation period were deemed as primary effectiveness failures'}, {'measure': 'Incidence of Primary Adverse Events Within Specified Study Period', 'timeFrame': '12 months post procedure', 'description': 'Primary safety endpoint consists of primary adverse events (AE) within 7 days post procedure Or pulmonary vein stenosis and atrio-esophageal fistula events that occurred within 12 months post-procedure. Primary adverse events include death, myocardial infarction, pulmonary vein stenosis, diaphragmatic paralysis, atrio-esophageal fistula, transient ischemic attack, stroke / cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade, pericardial effusion, pneumothorax, atrial perforation, vascular access complications, pulmonary edema, initial and prolonged hospitalization (excluding those due to pre-existing arrhythmia recurrence), heart block.'}], 'secondaryOutcomes': [{'measure': 'Peri-procedural Serious Adverse Events', 'timeFrame': 'Within 8-30 days post procedure', 'description': 'Peri-procedural serious adverse events (SAEs) are those non-primary SAEs occurred within 8-30 days post procedure'}, {'measure': 'Percentage of Subjects Achieved Acute Effectiveness', 'timeFrame': '5 hours of procedure time', 'description': 'Acute effectivenesss is defined as confirmation of entrance block into all Pulmonary veins'}, {'measure': 'Late Onset Serious Adverse Events', 'timeFrame': 'From 31 days post procedure to month 12', 'description': 'Late onset serious adverse events (SAEs) are those non-primary SAEs occurred after 31 days post procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Drug refractory', 'Atrial fibrillation', 'Antiarrhythmic drug failure', 'Atrial tachyarrhythmias'], 'conditions': ['Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multicenter, non-randomized continued access clinical evaluation utilizing the THERMOCOOL® SMARTTOUCH™ catheter.', 'detailedDescription': 'The device is currently under investigation with IDE #G110030. This continued access study will enroll subjects that have participated in the Smart-AF IDE study. Subjects with drug refractory symptomatic paroxysmal atrial fibrillation (PAF) will be considered for this study. Effectiveness and safety endpoints have been defined and will be evaluated post treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have had at least 3 atrial fibrillation episodes within 6 months of this study\n* Have failed at least one antiarrhythmic drug shown by repeated atrial fibrillation episodes\n* 18 years of age or older\n\nExclusion Criteria including, but not limited to:\n\n* Have had previous ablation for atrial fibrillation\n* Have take amiodarone within 6 months of this study\n* Have had any heart surgery within the last 60 days\n* Have had a heart attack within the last 60 days\n* Females who are pregnant or breast feeding'}, 'identificationModule': {'nctId': 'NCT01639495', 'briefTitle': 'THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation CONTINUED ACCESS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biosense Webster, Inc.'}, 'officialTitle': 'THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation Continued Access', 'orgStudyIdInfo': {'id': 'SMART-AF CA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'THERMOCOOL® SMARTTOUCH™ Catheter', 'interventionNames': ['Device: THERMOCOOL® SMARTTOUCH™ Catheter']}], 'interventions': [{'name': 'THERMOCOOL® SMARTTOUCH™ Catheter', 'type': 'DEVICE', 'description': 'AF Ablation', 'armGroupLabels': ['THERMOCOOL® SMARTTOUCH™ Catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama, Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Heart Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loyola University Chicago', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Hospitals', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Abbott Northwestern Hospital', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55902', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '07450', 'city': 'Ridgewood', 'state': 'New Jersey', 'country': 'United States', 'facility': 'The Valley Hospital', 'geoPoint': {'lat': 40.97926, 'lon': -74.11653}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mt. Sinai School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennslyvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Cardiac Arrhythmia Foundation', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '23219', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biosense Webster, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}