Evaluating the safety and outcomes of a leadless pacemaker
Aveir Single-Chamber Leadless Pacemaker Coverage With Evidence Development (ACED) Post-Approval Study
This study is testing whether a new leadless pacemaker is safer and leads to better health outcomes for Medicare patients compared to traditional pacemakers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 8744 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abbott Medical Devices Industry-sponsored |
| Locations | 1 site (Sylmar, California) |
| Trial ID | NCT05336877 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the complications and long-term health outcomes associated with the Aveir Single-Chamber Leadless Pacemaker device. It utilizes a non-randomized, multi-center approach, merging real-world datasets from Abbott and the Center for Medicare Services. The study will compare the safety and health outcomes of patients implanted with the Aveir VR LP against those with traditional single-chamber transvenous pacemakers. The cohort will include Medicare patients from across the United States who meet the eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are Medicare beneficiaries who have received either an Aveir VR leadless pacemaker or a single-chamber transvenous pacemaker.
Not a fit: Patients who do not meet the Medicare eligibility criteria or those who have not received either type of pacemaker will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of leadless pacemakers, potentially improving patient care in cardiac pacing.
How similar studies have performed: While this study is focused on a specific leadless pacemaker, similar studies evaluating leadless devices have shown promising results in terms of safety and efficacy.
Eligibility criteria
Show full inclusion / exclusion criteria
The study cohort will include all Medicare patients with continuous claims data implanted with an Aveir VR leadless pacemaker or a full-system single-chamber ventricular transvenous pacemaker (from any manufacturer) in any US location Inclusion Criteria: Medicare beneficiaries implanted with an Aveir VR leadless pacemaker on or after the study start date (i.e., the date of Aveir VR market approval) will be included in the study. OR Medicare beneficiaries implanted with a full system (e.g. lead and generator) single-chamber ventricular transvenous pacemaker on or after the study start date Exclusion Criteria: None
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.