Aveir VR Coverage With Evidence Development Post-Approval Study
Trial Parameters
Brief Summary
The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the single-chamber Aveir Single-Chamber Leadless Pacemaker device (Aveir VR LP).
Eligibility Criteria
The study cohort will include all Medicare patients with continuous claims data implanted with an Aveir VR leadless pacemaker or a full-system single-chamber ventricular transvenous pacemaker (from any manufacturer) in any US location Inclusion Criteria: Medicare beneficiaries implanted with an Aveir VR leadless pacemaker on or after the study start date (i.e., the date of Aveir VR market approval) will be included in the study. OR Medicare beneficiaries implanted with a full system (e.g. lead and generator) single-chamber ventricular transvenous pacemaker on or after the study start date Exclusion Criteria: None