An Intervention to Impact Cardiovascular Implantable Elec... | NCT05062434

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

NCT05062434

Sponsor

VA Office of Research and Development

Status

Not yet recruiting

Last Update Posted

Apr 2, 2026Actual

Enrollment

12Estimated

Phase

Not Applicable

Conditions

Patient Safety

Interventions

Academic detailing and audit and feedback intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1IK2HX003357-01A1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2026Estimated

Primary Completion Date

Aug 2, 2027Estimated

Completion Date

Sep 2, 2027Estimated

First Submitted Date

Sep 9, 2021

First Submission Date that Met QC Criteria

Sep 20, 2021

First Posted Date

Sep 30, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2026

Last Update Posted Date

Apr 2, 2026Actual

Name	Class
University of California, San Francisco	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention Arm	Experimental	VA cardiac electrophysiologists receiving the intervention	Other: Academic detailing and audit and feedback intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sanket S Dhruva, MD MHS	Contact	(415) 221-4810	26139	sanket.dhruva2@va.gov

Overall Officials

Name	Affiliation	Role
Sanket Shishir Dhruva, MD MHS	San Francisco VA Medical Center, San Francisco, CA	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
San Francisco VA Medical Center, San Francisco, CA		San Francisco	California	94121-1563	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided