Post-Approval Study of Aveir VR Leadless Pacemaker Compared to Single-Chamber Transvenous Pacemakers Using Real-World Medicare Data to Assess Safety and Long-Term Outcomes

What this Trial Is About

Researchers are evaluating the complications and long-term health outcomes of the single-chamber Aveir Single-Chamber Leadless Pacemaker device Aveir VR LP. This observational coverage with evidence development study compares the safety and health results of the Aveir VR LP to those of patients implanted with single-chamber transvenous pacemakers from any manufacturer. The study uses a large patient population by merging real-world data from Abbott and the Center for Medicare Services. The study includes Medicare patients implanted with either the Aveir VR Leadless Pacemaker System or a single-chamber ventricular transvenous pacemaker. No new device intervention is required, as the study relies on existing real-world data from these patients. The two groups serve as the study and comparator arms to assess differences in outcomes. Participants are followed using their medical claims and health records to monitor outcomes such as device-related complications within 30 days and survival after two years. Secondary outcomes include chronic device-related complications at six months and any device-related re-interventions within two years. The study began in June 2022 and will continue through 2028, tracking long-term safety and effectiveness measures without requiring new visits or procedures.

Aveir VR Coverage With Evidence Development Post-Approval Study