Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-25 @ 6:57 PM
Study NCT ID:
NCT00971204
Status:
COMPLETED
Last Update Posted:
2016-08-01
First Post:
2009-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation
Sponsor:
Organization:
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': 'bbarrett@cardiofocus.com', 'phone': '508 658-7200', 'title': 'Burke Barrett, VP Regulatory & Clinical Affairs', 'organization': 'CardioFocus, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Treatment With HeartLight', 'description': 'Treatment of PAF with HeartLight', 'otherNumAtRisk': 86, 'otherNumAffected': 23, 'seriousNumAtRisk': 86, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Chest pain/discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Cardiac disorders'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Cardiac disorders'}, {'term': 'Phrenic nerve injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}], 'seriousEvents': [{'term': 'Cardiac perforation, pericardial effusion, tamponade', 'notes': 'Participants may have more than one reported AE.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericarditis', 'notes': 'Participants may have more than one reported AE.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Phrenic nerve injury', 'notes': 'Participants may have more than one reported AE.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death, unrelated to investigational device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Freedom From Recurrence of Atrial Fibrillation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With HeartLight', 'description': 'Treatment of PAF with HeartLight System\n\nCardioFocus HeartLight Endoscopic Ablation System: PVI ablation'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Absence of symptomatic atrial fibrillation lasting one minute or more beyond the 90-day blanking period during the 12 month evaluation period.', 'unitOfMeasure': 'successful participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Effectiveness Endpoint participants. Of the 86 enrolled and treated participants, 84 were evaluable for the effectiveness endpoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment With EAS-AC', 'description': 'Treatment of PAF with EAS-AC\n\nCardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC): PVI ablation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '100 enrolled participants', 'groupId': 'FG000', 'numSubjects': '100'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '86 participants were treated and of these 86, 76 completed the study.', 'groupId': 'FG000', 'numSubjects': '76'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Did not meet all criteria-not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment With HeartLight', 'description': 'Treatment of PAF with HeartLight System PVI ablation'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.7', 'spread': '10.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '79', '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': '86', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '100 participants were enrolled in the study. 86 participants that met all inclusion/exclusion criteria received treatment with the HeartLight System and are included in the reported results.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-27', 'studyFirstSubmitDate': '2009-09-02', 'resultsFirstSubmitDate': '2016-04-18', 'studyFirstSubmitQcDate': '2009-09-02', 'lastUpdatePostDateStruct': {'date': '2016-08-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-06-16', 'studyFirstPostDateStruct': {'date': '2009-09-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom From Recurrence of Atrial Fibrillation', 'timeFrame': '12 months', 'description': 'Absence of symptomatic atrial fibrillation lasting one minute or more beyond the 90-day blanking period during the 12 month evaluation period.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'PAF'], 'conditions': ['Paroxysmal Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'This is a demonstration of safety and efficacy of the ablation for pulmonary vein isolation in the treatment of paroxysmal atrial fibrillation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 70 years\n* paroxysmal atrial fibrillation\n* failure of at least one AAD\n* others\n\nExclusion Criteria:\n\n* overall good health as established by multiple criteria'}, 'identificationModule': {'nctId': 'NCT00971204', 'briefTitle': 'Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation', 'organization': {'class': 'INDUSTRY', 'fullName': 'CardioFocus'}, 'officialTitle': 'Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation', 'orgStudyIdInfo': {'id': '25-2734'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment with HeartLight System', 'description': 'Treatment of paroxysmal atrial fibrillation (PAF) with HeartLight System', 'interventionNames': ['Device: CardioFocus HeartLight Endoscopic Ablation System']}], 'interventions': [{'name': 'CardioFocus HeartLight Endoscopic Ablation System', 'type': 'DEVICE', 'description': 'PVI ablation', 'armGroupLabels': ['Treatment with HeartLight System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Heart Institute', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '48072', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mt. Sinai Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania Health System', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Cardiac Arrhythmia Research Foundation', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The Methodist Hospital Research Institute', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University Of Virginia Health System', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Sentara Norfolk General Hospital', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Burke Barret', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CardioFocus, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CardioFocus', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}