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

NCT ID: NCT05062434

Last Updated: 2025-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-02

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Patient Safety

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention Arm

VA cardiac electrophysiologists receiving the intervention

Group Type EXPERIMENTAL

Academic detailing and audit and feedback intervention

Intervention Type 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.

Interventions

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Academic 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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role collaborator

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sanket Shishir Dhruva, MD MHS

Role: PRINCIPAL_INVESTIGATOR

San Francisco VA Medical Center, San Francisco, CA

Locations

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San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, United States

Site Status

Countries

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United States

Central Contacts

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Sanket S Dhruva, MD MHS

Role: CONTACT

(415) 221-4810 ext. 26139

Facility Contacts

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Sanket S Dhruva, MD MHS

Role: primary

(415) 221-4810 ext. 26139

Other Identifiers

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1IK2HX003357-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDX 21-007

Identifier Type: -

Identifier Source: org_study_id

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