Overview
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).
Description
This is a non-randomized, multi-center study leveraging real-world evidence methods that merge multiple real-world datasets from Abbott and the Center for Medicare Services to compare Aveir VR LP safety and health outcomes to those in patients implanted with single-chamber transvenous pacemakers in a large patient population.
The study will enroll all Medicare patients implanted with the Aveir VR LP and, as the control group, patients implanted with a single-chamber ventricular transvenous pacemaker from any manufacturer.
Eligibility
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