Ignite Creation Date:
2025-12-24 @ 2:05 PM
Ignite Modification Date:
2026-02-01 @ 6:18 PM
Study NCT ID:
NCT03164395
Status:
COMPLETED
Last Update Posted:
2019-03-22
First Post:
2017-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Single Coil Defibrillation Leads for Internal Cardioversion of Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized in block fashion to either internal or external cardioversion'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-20', 'studyFirstSubmitDate': '2017-05-21', 'studyFirstSubmitQcDate': '2017-05-21', 'lastUpdatePostDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute Conversion of Atrial Fibrillation to Sinus Rhythm', 'timeFrame': 'Immediate', 'description': 'Does the patient return for at least one beat to sinus rhythm following the administration of a shock'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'implantable cardiac defibrillator', 'cardioversion'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'This study seeks to determine the efficacy of single coil defibrillation leads for cardioversion of persistent atrial fibrillation.', 'detailedDescription': "This study seeks to compare the efficacy of single coil defibrillation leads for the internal cardioversion of atrial fibrillation as compared with cardioversion by external defibrillation pads. It is known that dual coil leads are effective for atrial cardioversion, but the presence of the SVC defibrillation coil allows for selection of shock vector that more reliably incorporates the majority of atrial tissue compared to a single right ventricular lead. For a variety of reasons single coil defibrillation leads are now implanted in the majority of patients requiring placement of implantable cardiac defibrillators, and many of these patient's will later develop atrial fibrillation and potentially require cardioversion. Currently, there is no clear consensus on how to approach cardioversion in these patient's and both external and internal methods are used. Internal cardioversion may be ineffective exposing patient's unnecessarily to repeated shocks and battery depletion. External cardioversion may carry a small risk of damaged to the CIED.\n\nThe investigator's goal is to identify patient's referred for cardioversion for atrial fibrillation who also have an implanted cardiac defibrillator with a single coil defibrillation lead and randomize them to either external or internal cardioversion."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* greater than 18 years of age\n* persistent atrial fibrillation and have been recommended by your primary cardiologist to undergo cardioversion\n* have an implantable cardiac defibrillator\n\nExclusion Criteria:\n\n* over the age of 99\n* pregnant\n* prisoner'}, 'identificationModule': {'nctId': 'NCT03164395', 'briefTitle': 'The Efficacy of Single Coil Defibrillation Leads for Internal Cardioversion of Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'The Efficacy of Single Coil Defibrillation Leads for Internal Cardioversion of Persistent Atrial Fibrillation', 'orgStudyIdInfo': {'id': '16-0536'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Internal Cardioversion', 'description': 'Patients randomized to external cardioversion will undergo external synchronized cardioversion per institutional protocol.', 'interventionNames': ['Procedure: Internal Cardioversion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'External Cardioversion', 'description': 'Patients randomized to internal cardioversion will have a maximum energy shock delivered from the device between the RV coil and can. If cardioversion is not successful they will then undergo external cardioversion per institutional protocol.', 'interventionNames': ['Procedure: External Cardioversion']}], 'interventions': [{'name': 'Internal Cardioversion', 'type': 'PROCEDURE', 'description': 'Internal Cardioversion with device maximum output shock from RV coil to Can versus external cardioversion per institutional protocol', 'armGroupLabels': ['Internal Cardioversion']}, {'name': 'External Cardioversion', 'type': 'PROCEDURE', 'description': 'External Cardioversion per institutional protocol', 'armGroupLabels': ['External Cardioversion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40506', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'Samy C Elayi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Kentucky'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kentucky', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Samy C Elayi, MD', 'investigatorAffiliation': 'University of Kentucky'}}}}