Evaluating the long-term safety of the Aveir DR leadless pacemaker
Aveir Dual-Chamber Leadless Pacemaker Real-World Evidence Post-Approval Study
This study is testing the long-term safety of the Aveir DR leadless pacemaker in real-world patients to make sure it’s safe for use.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1805 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abbott Medical Devices Industry-sponsored |
| Locations | 1 site (Sylmar, California) |
| Trial ID | NCT05935007 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the long-term safety of the dual-chamber Aveir DR leadless pacemaker using 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 Aveir DR device in a large patient population. The findings will fulfill the FDA's Condition of Approval requirements for the Aveir DR device by providing essential long-term safety data.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who have been implanted with an Aveir DR leadless pacemaker and meet specific Medicare enrollment criteria.
Not a fit: Patients who have not received an Aveir DR leadless pacemaker or do not meet the Medicare enrollment criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the long-term safety of the Aveir DR leadless pacemaker, potentially improving patient outcomes.
How similar studies have performed: Other studies utilizing real-world evidence methods have shown promise in evaluating medical devices, suggesting that this approach could yield valuable safety data.
Eligibility criteria
Show full inclusion / exclusion criteria
Eligibility Criteria: * Implanted with an Aveir DR 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.