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NCT Number: NCT05062434

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

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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121-1563, United States

Location contact

Sanket S Dhruva, MD MHS

CONTACT

[email protected]

(415) 221-4810 ext. 26139

Sanket Shishir Dhruva, MD MHS

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Academic detailing and audit and feedback intervention

Other

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.

Primary outcomes

  1. Proportion of cardiovascular implantable electronic device leads that are of the lead model with the lowest failure rate

    Time frame: 3 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sanket S Dhruva, MD MHS

CONTACT

[email protected]

(415) 221-4810 ext. 26139

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • University of California, San Francisco

Registry information

Official study title

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

Acronym: Veteran CIEDs

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 30, 2021
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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