Abbott Medical Devices
The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the dual chamber Aveir Leadless Pacemaker device (aka Aveir™ DR LP system).
Cardiac Pacemaker
Arrythmia
Bradycardia
Aveir DR Leadless Pacemaker System
Dual Chamber Transvenous Pacemaker
This CED study utilizes a real-world evidence (RWE) method merging multiple real-world datasets from Abbott and the Center for Medicare Services to assess Aveir DR LP health outcomes among Medicare beneficiaries. The study will enroll all Medicare patients with continuous claims data implanted with the Aveir DR LP system or a dual-chamber transvenous pacemaker system from any manufacturer. Due to the RWE data collection methods used in this study, a central institutional review board (IRB) approved informed consent waiver has been granted. Due to this waiver and the sponsor's use of the central IRB, individual hospitals are not required to consent patients or complete local IRB submissions for this RWE study.
| Study Type : | OBSERVATIONAL |
| Estimated Enrollment : | 2812 participants |
| Official Title : | The AVEIR DR Coverage With Evidence Development (DRIVE) Study |
| Actual Study Start Date : | 2023-10-31 |
| Estimated Primary Completion Date : | 2029-05 |
| Estimated Study Completion Date : | 2030-05 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Abbott
Sylmar, California, United States, 91342