Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-31 @ 11:24 AM
Study NCT ID:
NCT05062434
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-03
First Post:
2021-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Intervention to Impact Cardiovascular Implantable Electronic Device Lead Models Implanted in Veterans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a pilot study for cardiac electrophysiologists at 3 Veterans Integrated Service Networks.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2021-09-09', 'studyFirstSubmitQcDate': '2021-09-20', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of cardiovascular implantable electronic device leads that are of the lead model with the lowest failure rate', 'timeFrame': '3 months', 'description': 'This outcome will be the proportion of cardiovascular implantable electronic device leads implanted in the 3 months post-intervention that are of the lead model with the lowest failure rate. The failure rates for the lead models will be available from VA data.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Defibrillators, Implantable', 'Pacemaker, Artificial'], 'conditions': ['Patient Safety']}, 'descriptionModule': {'briefSummary': 'This study will evaluate if an intervention using academic detailing and audit and feedback impacts the specific pacemaker or implantable cardioverter-defibrillator (ICD) lead models implanted in Veterans.', 'detailedDescription': "This study will identify Department of Veterans Affairs (VA)-based cardiac electrophysiologists at three Veterans Integrated Service Networks (VISNs). Each cardiac electrophysiologist will participate in a videoconference during which time an academic detailing and audit and feedback intervention will be implemented, which will include details and recommendations about lead selection for implantation, based on cardiovascular implantable electronic device (CIED: pacemaker and implantable cardioverter-defibrillator \\[ICD\\]) lead-specific failure rates for lead models currently available in clinical practice. The cardiac electrophysiologist will also be presented with quantitative data about the individual physician's facility's implants and national data on implants over the past year. These data will be shared in advance, with time for questions and discussion. The electrophysiologist will be asked if anything can be done to facilitate selection of CIED lead models with the statistically and clinically significantly lower failure rates.\n\nThen, over the subsequent 3 months, a quantitative evaluation of the CIED lead models implanted will be evaluated, comparing changes in lead model selection among the electrophysiologists receiving the intervention to a control group of all VA cardiac electrophysiologists who do not receive the intervention. Subsequently, semi-structured interviews will be conducted to assess reasons for changes, or lack thereof, in CIED lead model selection - including barriers and facilitators. Finally, quantitative data will be included to each of the cardiac electrophysiologists, with additional feedback."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Department of Veterans Affairs-based cardiac electrophysiologists who implant cardiovascular implantable electronic devices at three Veterans Integrated Service Networks (VISNs)\n\nExclusion Criteria:\n\n* Not willing to participate in the study'}, 'identificationModule': {'nctId': 'NCT05062434', 'acronym': 'Veteran CIEDs', 'briefTitle': 'An Intervention to Impact Cardiovascular Implantable Electronic Device Lead Models Implanted in Veterans', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Improving Safety of Cardiovascular Implantable Electronic Devices in Veterans (CDA 21-057)', 'orgStudyIdInfo': {'id': 'CDX 21-007'}, 'secondaryIdInfos': [{'id': '1IK2HX003357-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1IK2HX003357-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Arm', 'description': 'VA cardiac electrophysiologists receiving the intervention', 'interventionNames': ['Other: Academic detailing and audit and feedback intervention']}], 'interventions': [{'name': 'Academic detailing and audit and feedback intervention', 'type': 'OTHER', 'description': "An academic detailing and audit and feedback intervention will be presented to VA cardiac electrophysiologists, and will include quantitative data about the individual physician's facilities cardiovascular implantable electronic device lead implants and national data on lead implants over the past year.", 'armGroupLabels': ['Intervention Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94121-1563', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Sanket S Dhruva, MD MHS', 'role': 'CONTACT', 'email': 'sanket.dhruva2@va.gov', 'phone': '(415) 221-4810', 'phoneExt': '26139'}, {'name': 'Sanket Shishir Dhruva, MD MHS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'San Francisco VA Medical Center, San Francisco, CA', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Sanket S Dhruva, MD MHS', 'role': 'CONTACT', 'email': 'sanket.dhruva2@va.gov', 'phone': '(415) 221-4810', 'phoneExt': '26139'}], 'overallOfficials': [{'name': 'Sanket Shishir Dhruva, MD MHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Francisco VA Medical Center, San Francisco, CA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'collaborators': [{'name': 'University of California, San Francisco', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}