Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-29 @ 7:40 PM
Study NCT ID:
NCT00519194
Status:
TERMINATED
Last Update Posted:
2019-02-19
First Post:
2007-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CONcomitant eValuation of Epicor Left atRial Therapy for AF
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'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': 'swalgren@sjm.com', 'phone': '6517563210', 'title': 'Sue Walgren, Manager Sr., Clinical Project', 'organization': 'St. Jude Medical'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Epicor Cardiac Ablation', 'description': 'Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery\n\nSurgical ablation of permanent AF: Concomitant AF ablation during mitral valve surgery', 'otherNumAtRisk': 112, 'otherNumAffected': 1, 'seriousNumAtRisk': 112, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Acute heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Cardiac injury related to Epicor device rsulting in unplanned surgical or catheter intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Newly developed third degree AV block requiring permanent pacemaker implantation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral arterial embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Freedom From Atrial Fibrillation in the Absence of Any AF Therapies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Epicor Cardiac Ablation', 'description': 'Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery\n\nSurgical ablation of permanent AF: Concomitant AF ablation during mitral valve surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Freedom from atrial fibrillation (AF) at 6 months in absence of any AF therapies.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Epicor Cardiac Ablation', 'description': 'Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery\n\nSurgical ablation of permanent AF: Concomitant AF ablation during mitral,aortic, and or tricuspid valve surgery, PFO closure or CABG procedure'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Epicor Cardiac Ablation', 'description': 'Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery\n\nSurgical ablation of permanent AF: Concomitant AF ablation during mitral valve surgery'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.4', 'spread': '6.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '67', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '112', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Subjects treated'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-01', 'studyFirstSubmitDate': '2007-08-20', 'resultsFirstSubmitDate': '2014-03-31', 'studyFirstSubmitQcDate': '2007-08-20', 'lastUpdatePostDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-04-01', 'studyFirstPostDateStruct': {'date': '2007-08-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom From Atrial Fibrillation in the Absence of Any AF Therapies', 'timeFrame': '6 months', 'description': 'Freedom from atrial fibrillation (AF) at 6 months in absence of any AF therapies.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Arrhythmia', 'Atrial Fibrillation'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the safety and efficacy of the Epicor LP Cardiac Ablation System for treating permanent atrial fibrillation during concomitant open chest and/or open heart surgery for one of more of the following procedures: mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, coronary artery bypass surgery or patent foramen ovale (PFO closure).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-80 years old\n* Permanent AF defined as continuous AF lasting \\> one year OR non self-terminating AF lasting \\> seven days but no more than one year with at least one failed DC cardioversion\n* Have a concomitant indication for open chest and/or open heart surgery for one or more of the following: mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, patent foramen ovale (PFO) closure or coronary artery bypass surgery\n* Be able to take anticoagulation therapy\n* Be able to fulfill study requirements\n* Be able to sign study-specific informed consent\n\nExclusion Criteria:\n\n* Presence of a previously implanted device in or adjacent to the treatment target area that may alter the delivery of therapy\n* Prior cardiac surgery\n* Presence of active endocarditis, local or system infection\n* Presence of advanced heart failure (NYHA class \\> II, \\& LVEF \\< 20%)\n* Intraaortic balloon pump, IV inotropes or vasoactive agents within 30 days\n* Emergent cardiac surgery due to acute MI or acute mitral regurgitation\n* Life expectancy \\< 1 year\n* Major or progressive non-cardiac disease\n* Presence of left atrial thrombi\n* Left atrial diameter \\> 6.0 cm\n* Any condition that prevents investigator from safely performing procedure\n* Positive urine or serum pregnancy test\n* Prior left atrial ablation\n* Currently participating in another clinical research study'}, 'identificationModule': {'nctId': 'NCT00519194', 'acronym': 'CONVERT-AF', 'briefTitle': 'CONcomitant eValuation of Epicor Left atRial Therapy for AF', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'CONcomitant eValuation of Epicor Left atRial Therapy for AF', 'orgStudyIdInfo': {'id': '051.13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Epicor Cardiac Ablation', 'interventionNames': ['Device: Epicor LP Cardiac Ablation System', 'Procedure: Surgical ablation of permanent AF']}], 'interventions': [{'name': 'Epicor LP Cardiac Ablation System', 'type': 'DEVICE', 'description': 'Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery', 'armGroupLabels': ['Epicor Cardiac Ablation']}, {'name': 'Surgical ablation of permanent AF', 'type': 'PROCEDURE', 'description': 'Concomitant AF ablation during mitral valve surgery', 'armGroupLabels': ['Epicor Cardiac Ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'St. Agnes Medical Center', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '34208', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Manatee Memorial Hospital', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '34209', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Blake Medical Center', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '32501', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': "Cardiology Consultants, MD's PA (Baptist Hospital)", 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'NorthShore University Health System', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '46321', 'city': 'Munster', 'state': 'Indiana', 'country': 'United States', 'facility': 'Community Hospital', 'geoPoint': {'lat': 41.56448, 'lon': -87.51254}}, {'zip': '21218', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Midatlanatic Cardiovascular Associates, PA; Union Memorial Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis Heart Institute Foundation/Abbott NW Hospital', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55102', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': "HealthEast St. Joseph's Hospital", 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '11576', 'city': 'Roslyn', 'state': 'New York', 'country': 'United States', 'facility': 'St. Francis Hospital', 'geoPoint': {'lat': 40.79982, 'lon': -73.65096}}, {'zip': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Mission Hospital, Inc', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Mark Groh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mission Hospitals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}