Evaluating the Aveir Atrial Leadless Pacemaker for Medicare Patients
Aveir AR Coverage With Evidence Development (CED) Study
Abbott Medical Devices · NCT06100770
This study is testing how well the Aveir Atrial Leadless Pacemaker works and what complications it might cause for Medicare patients compared to a regular pacemaker.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 586 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abbott Medical Devices (industry) |
| Locations | 1 site (Sylmar, California) |
| Trial ID | NCT06100770 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the complications and long-term health outcomes associated with the Aveir Atrial Leadless Pacemaker device among Medicare beneficiaries. By utilizing real-world evidence methods, the study merges multiple datasets from Abbott and the Center for Medicare Services to evaluate health outcomes for patients implanted with either the Aveir AR LP or a single-chamber atrial transvenous pacemaker. The study does not require individual patient consent due to an approved informed consent waiver, allowing for a broader analysis of real-world data.
Who should consider this trial
Good fit: Ideal candidates for this study are Medicare beneficiaries who have received an Aveir AR leadless pacemaker or a single-chamber atrial transvenous pacemaker.
Not a fit: Patients who do not have a Medicare insurance plan or 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 the Aveir AR leadless pacemaker, potentially improving patient outcomes.
How similar studies have performed: Other studies utilizing real-world evidence to assess medical devices have shown promise, indicating that this approach may yield valuable data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Medicare beneficiaries implanted with an Aveir AR leadless pacemaker on or after the study start date (i.e., the date of Aveir AR market approval) will be included in the study. OR 2. Medicare beneficiaries implanted with a full system (e.g. lead and generator) single chamber atrial 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.
Conditions: Cardiac Pacemaker, Arrhythmia, Bradycardia