NCT05062434

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
10mo left

Started Nov 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 30, 2021

Completed
5.1 years until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2027

Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

September 9, 2021

Last Update Submit

March 27, 2026

Conditions

Patient Safety

Keywords

Defibrillators, ImplantablePacemaker, Artificial

Outcome Measures

Primary Outcomes (1)

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

    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.

    3 months

Study Arms (1)

Intervention Arm

EXPERIMENTAL

VA cardiac electrophysiologists receiving the intervention

Other: Academic detailing and audit and feedback intervention

Interventions

Academic detailing and audit and feedback interventionOTHER

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 Arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Not willing to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121-1563, United States

Location

Study Officials

  • Sanket Shishir Dhruva, MD MHS

    San Francisco VA Medical Center, San Francisco, CA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanket S Dhruva, MD MHS

CONTACT

(415) 221-4810sanket.dhruva2@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: This is a pilot study for cardiac electrophysiologists at 3 Veterans Integrated Service Networks.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2021

First Posted

September 30, 2021

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

August 2, 2027

Study Completion (Estimated)

September 2, 2027

Last Updated

April 2, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)