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

Study to Improve Pacemaker and ICD Safety for Veterans

NCT: NCT05062434 · Status: NOT YET RECRUITING · Phase: N/A · Sponsor: VA Office of Research and Development · Started: 2026-11-01 · Est. Completion: 2027-09-02

Plain English Summary

An Intervention to Impact Cardiovascular Implantable Electronic Device Lead Models Implanted in Veterans is a Not Applicable clinical trial sponsored by VA Office of Research and Development studying Patient Safety. Evaluates an intervention to improve the safety of specific pacemaker and ICD lead models used in Veterans. For VA-based cardiac electrophysiologists who implant these devices at three Veterans Integrated Service Networks. Participation involves attending academic detailing and receiving audit and feedback on lead implant practices. No alternatives exist for this specific study, but general patient safety measures are always available. The trial aims to enroll 12 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. VA-based cardiac electrophysiologists who implant cardiovascular implantable electronic devices at three Veterans Integrated Service Networks can join. Non-VA-based electrophysiologists or those not implanting devices at the specified locations cannot join. Age and health requirements are not specified in the eligibility criteria. Participants must be willing to participate in the study. This trial is studying Patient Safety, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures the proportion of leads that are of the model with the lowest failure rate, which means safer devices for Veterans. The specific primary outcome measures are: Proportion of cardiovascular implantable electronic device leads that are of the lead model with the lowest failure rate (3 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial aims to fill a treatment gap by improving the safety of specific pacemaker and ICD lead models used in Veterans. This research targets Patient Safety, where improved treatment options are needed.

Investor Insight

The market size for cardiovascular implantable electronic devices is large, with a competitive landscape that could benefit from successful outcomes.

Is This Trial Right for Me?

Ask your doctor if you are a VA-based cardiac electrophysiologist and if you implant devices at one of the specified Veterans Integrated Service Networks. Participation involves attending academic detailing and receiving audit and feedback on lead implant practices. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

  • Study Type: INTERVENTIONAL
  • Allocation: NA
  • Model: SINGLE_GROUP
  • Masking: NONE
  • Enrollment: 12 participants

Interventions

  • OTHER: 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.

Primary Outcomes

  • Proportion of cardiovascular implantable electronic device leads that are of the lead model with the lowest failure rate (3 months)

Full 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

Trial Locations

  • San Francisco VA Medical Center, San Francisco, CA, San Francisco, California, United States

Frequently Asked Questions

What is clinical trial NCT05062434?

NCT05062434 is a Not Applicable INTERVENTIONAL study titled "An Intervention to Impact Cardiovascular Implantable Electronic Device Lead Models Implanted in Veterans." It is currently not yet recruiting and is sponsored by VA Office of Research and Development. The trial targets enrollment of 12 participants.

What conditions does NCT05062434 study?

This trial investigates treatments for Patient Safety. The primary condition under study is Patient Safety.

What treatments are being tested in NCT05062434?

The interventions being studied include: 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.

What does Not Applicable mean for NCT05062434?

This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.

What is the current status of NCT05062434?

This trial is currently "Not Yet Recruiting." It started on 2026-11-01. The estimated completion date is 2027-09-02.

Who is sponsoring NCT05062434?

NCT05062434 is sponsored by VA Office of Research and Development. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT05062434?

The trial aims to enroll 12 participants. The trial has not yet started recruiting.

How is NCT05062434 designed?

This is a interventional study, uses na allocation, follows a single_group design, employs none masking.

What are the primary outcomes being measured in NCT05062434?

The primary outcome measures are: Proportion of cardiovascular implantable electronic device leads that are of the lead model with the lowest failure rate (3 months). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT05062434 being conducted?

This trial is being conducted at 1 site, including San Francisco, California (United States).

Where can I find official information about NCT05062434?

The official record for NCT05062434 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05062434. This government database provides the most up-to-date and detailed information about the trial.

What is NCT05062434 testing in simple terms?

Evaluates an intervention to improve the safety of specific pacemaker and ICD lead models used in Veterans. For VA-based cardiac electrophysiologists who implant these devices at three Veterans Integrated Service Networks.

Why is this trial significant?

This trial aims to fill a treatment gap by improving the safety of specific pacemaker and ICD lead models used in Veterans.

What are the potential risks of participating in NCT05062434?

There are no specific key risks or side effects mentioned for this study. However, the intervention involves receiving feedback on implant practices, which could be beneficial. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT05062434?

Ask your doctor if you are a VA-based cardiac electrophysiologist and if you implant devices at one of the specified Veterans Integrated Service Networks. Participation involves attending academic detailing and receiving audit and feedback on lead implant practices. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT05062434 signal from an investment perspective?

The market size for cardiovascular implantable electronic devices is large, with a competitive landscape that could benefit from successful outcomes. This is a Not Applicable trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participation involves attending academic detailing and receiving audit and feedback on lead implant practices. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

Related Conditions

More Patient Safety Trials

View all Patient Safety clinical trials

This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.