Evaluating the long-term safety of the Aveir VR leadless pacemaker
Aveir Single-Chamber Leadless Pacemaker Real-World Evidence Post-Approval Study
This study is testing the long-term safety of the Aveir VR leadless pacemaker in a large group of patients to see how well it works in real life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abbott Medical Devices Industry-sponsored |
| Locations | 1 site (Sylmar, California) |
| Trial ID | NCT05270499 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the long-term safety of the Aveir VR leadless pacemaker by utilizing real-world evidence methods. It is a non-randomized, multi-center study that combines various real-world datasets from Abbott and the Center for Medicare Services to evaluate the safety of the device in a large patient population. The findings will help fulfill the FDA's Condition of Approval requirements for the Aveir VR device.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who have been implanted with an Aveir VR leadless pacemaker and meet specific Medicare enrollment criteria.
Not a fit: Patients who have not received the Aveir VR leadless pacemaker or those who do not meet the Medicare enrollment criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety of the Aveir VR leadless pacemaker, potentially improving patient outcomes.
How similar studies have performed: Other studies evaluating leadless pacemakers have shown promising results, indicating that this approach is supported by prior successful research.
Eligibility criteria
Show full inclusion / exclusion criteria
Eligibility Criteria: * Implanted with an Aveir VR leadless pacemaker * Continuous enrollment in Medicare Part A and Part B for 12 months prior to implant and for 30 days after implant, except in the case of death within the 30-day period * Ability to link with Medicare fee-for-service data
Where this trial is running
Sylmar, California
- Abbott — Sylmar, California, United States (Recruiting)
Study contacts
- Study coordinator: Nicole Harbert
- Email: nicole.harbert@abbott.com
- Phone: 972-526-4841
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.