Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT01057394
Status:
TERMINATED
Last Update Posted:
2016-08-01
First Post:
2010-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post-Market Randomized Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation
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': {'timeFrame': 'Up to 3 months after treatment', 'eventGroups': [{'id': 'EG000', 'title': 'Visually Guided Ablation', 'description': 'Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation', 'otherNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Groin bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Permanent Pulmonary Vein Isolation of EAS-AC Compared to EAM Guided Radiofrequency Ablation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Number of Chronically Isolated Pulmonary Veins'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 Months', 'description': 'Number of initially isolated pulmonary veins that remain isolated at a 3 month remapping. The unit of measure is treated pulmonary veins (PVs).', 'unitOfMeasure': 'isolated pulmonary veins', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 21 enrolled participants, 19 were treated participants and 17 of the 19 came back for the 3 month PV remapping and were thus evaluable for effectiveness. This resulted in 46/59 (78%) pulmonary veins being assessed for chronic isolation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Radiofrequency Ablation', 'description': 'Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation'}, {'id': 'FG001', 'title': 'Visually Guided Ablation', 'description': 'Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': '21 enrolled participants', 'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': '19 treated participants', 'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Not eligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'The Sponsor stopped the study for business reasons before any participants were enrolled in the RF arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Visually Guided Ablation', 'description': 'Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'spread': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'whyStopped': 'Sponsor stopped study for business reasons; not for clinical or clinical outcomes reasons.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-27', 'studyFirstSubmitDate': '2010-01-26', 'resultsFirstSubmitDate': '2016-04-18', 'studyFirstSubmitQcDate': '2010-01-26', 'lastUpdatePostDateStruct': {'date': '2016-08-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-07-27', 'studyFirstPostDateStruct': {'date': '2010-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Permanent Pulmonary Vein Isolation of EAS-AC Compared to EAM Guided Radiofrequency Ablation', 'timeFrame': '3 Months', 'description': 'Number of initially isolated pulmonary veins that remain isolated at a 3 month remapping. The unit of measure is treated pulmonary veins (PVs).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atrial Fibrillation'], 'conditions': ['Paroxysmal Atrial Fibrillation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.cardiofocus.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'To compare the safety and chronic Pulmonary Vein isolation of 2 ablation types.\n\n1. visually guided ablation (VGA) using the EAS-AC and\n2. radiofrequency ablation', 'detailedDescription': 'The goal of the study was to compare two interventions, visually-guided endoscopic ablation to standard-of-care radiofrequency (RF) ablation. The study was terminated early by the Sponsor for business reasons before any participants were randomized or treated with RF ablation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Symptomatic, Paroxysmal Atrial Fibrillation (AF)\n* 18 to 75 Years of age\n* Generally good overall health as determined by multiple criteria\n* Willing to participate in a study\n* Others'}, 'identificationModule': {'nctId': 'NCT01057394', 'acronym': 'En-GARDE', 'briefTitle': 'Post-Market Randomized Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation', 'organization': {'class': 'INDUSTRY', 'fullName': 'CardioFocus'}, 'officialTitle': 'Post-Market Randomized Controlled Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation GuideD by Electroanatomical Mapping to Achieve Permanent Pulmonary Vein Isolation (En-GARDE)', 'orgStudyIdInfo': {'id': '25-2758'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Radiofrequency Ablation', 'description': 'PVI using RF ablation', 'interventionNames': ['Device: RF PVI Ablation']}, {'type': 'EXPERIMENTAL', 'label': 'Visually Guided Ablation', 'description': 'PVI using visually guided ablation with an endoscopic ablation system', 'interventionNames': ['Device: Endoscopically guided PVI Ablation']}], 'interventions': [{'name': 'Endoscopically guided PVI Ablation', 'type': 'DEVICE', 'description': 'Endoscopically Guided Ablation using the EAS-AC', 'armGroupLabels': ['Visually Guided Ablation']}, {'name': 'RF PVI Ablation', 'type': 'DEVICE', 'description': 'Radiofrequency ablation', 'armGroupLabels': ['Radiofrequency Ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '140 21', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Institute for Clinical and Experimental Medicine (IKEM)', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '00168', 'city': 'Rome', 'country': 'Italy', 'facility': 'Catholic University of the Sacred Heart', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Vivek Reddy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Mount Sinai Hospital, New York City'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CardioFocus', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}