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An Intervention to Impact Cardiovascular Implantable Electronic Device Lead Models Implanted in Veterans

Improving Safety of Cardiovascular Implantable Electronic Devices in Veterans (CDA 21-057)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05062434
Acronym
Veteran CIEDs
Enrollment
12
Registered
2021-09-30
Start date
2026-11-01
Completion date
2027-09-02
Last updated
2026-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Safety

Keywords

Defibrillators, Implantable, Pacemaker, Artificial

Brief summary

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.

Detailed description

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. Then, 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.

Interventions

OTHERAcademic detailing and audit and feedback intervention

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.

Sponsors

VA Office of Research and Development
Lead SponsorFED
University of California, San Francisco
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

This is a pilot study for cardiac electrophysiologists at 3 Veterans Integrated Service Networks.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Department of Veterans Affairs-based cardiac electrophysiologists who implant cardiovascular implantable electronic devices at three Veterans Integrated Service Networks (VISNs)

Exclusion criteria

* Not willing to participate in the study

Design outcomes

Primary

MeasureTime frameDescription
Proportion of cardiovascular implantable electronic device leads that are of the lead model with the lowest failure rate3 monthsThis 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.

Countries

United States

Contacts

CONTACTSanket S Dhruva, MD MHS
sanket.dhruva2@va.gov(415) 221-4810
PRINCIPAL_INVESTIGATORSanket Shishir Dhruva, MD MHS

San Francisco VA Medical Center, San Francisco, CA

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026