Study of Health Outcomes for Medicare Patients With Aveir DR Leadless or Dual-Chamber Transvenous Pacemakers

What this Trial Is About

This research aims to evaluate complications and long-term health outcomes of the dual chamber Aveir Leadless Pacemaker device, also called the Aveir DR LP system, among Medicare patients. It is a coverage with evidence development CED study using real-world evidence methods to merge data from Abbott and the Center for Medicare Services. The study includes patients who have received either the Aveir DR LP system or a dual-chamber transvenous pacemaker from any manufacturer. The study involves collecting real-world data from two groups patients implanted with the Aveir DR Leadless Pacemaker System and patients with a dual-chamber transvenous pacemaker system as a comparison group. No new device interventions are required during the study. Data collection relies on existing claims and health records, and individual patient consent is waived under central institutional review board approval. Participants will be observed through merged real-world datasets without additional visits or procedures. Researchers will monitor device-related complication rates at 30 days and 6 months, device-related re-intervention rates at 2 years, and overall survival at 2 years. The study includes Medicare beneficiaries implanted with the devices on or after the study start date, and participation involves ongoing data review to assess safety and health outcomes over time.

AVEIR DR Coverage With Evidence Development (CED) Study