Study of Health Outcomes in Medicare Patients Using Aveir AR Leadless and Single-Chamber Atrial Pacemakers

What this Trial Is About

Researchers are evaluating the safety and long-term health outcomes of the single-chamber Aveir Atrial Leadless Pacemaker device, also known as the Aveir20 AR LP system. This coverage with evidence development CED study focuses on Medicare patients implanted with this device or a similar single-chamber atrial transvenous pacemaker from any manufacturer. The study uses real-world evidence by merging multiple data sources from Abbott and the Center for Medicare Services to better understand device-related complications and survival rates. This observational study collects data without requiring any new device intervention. It includes two groups patients implanted with the Aveir AR Leadless Pacemaker and those with a single-chamber atrial transvenous pacemaker, serving as a comparison group. Both groups data come from real-world healthcare records, allowing researchers to assess outcomes over time without affecting patient treatment. Participants health data will be monitored for complications within 30 days and up to two years, including acute and chronic device-related issues and any need for device re-intervention. The study uses Medicare claims data and does not require individual patient consent due to an approved waiver. Outcomes such as survival rates and complication frequencies are tracked to understand device performance in real-world use, with the study planned to continue through January 2031.

Aveir AR Coverage With Evidence Development (CED) Study