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An Intervention to Impact Cardiovascular Implantable Electronic Device Lead Models Implanted in Veterans (Veteran CIEDs)

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VA Office of Research and Development

Status

Begins enrollment this month

Conditions

Patient Safety

Treatments

Other: Academic detailing and audit and feedback intervention

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT05062434
1IK2HX003357-01A1 (U.S. NIH Grant/Contract)
CDX 21-007

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

Intervention Arm
Experimental group
Description:
VA cardiac electrophysiologists receiving the intervention
Treatment:
Other: Academic detailing and audit and feedback intervention

Trial contacts and locations

1

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Central trial contact

Sanket S Dhruva, MD MHS

Data sourced from clinicaltrials.gov

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