Aveir VR Real-World Evidence Post-Approval Study

Aveir Single-Chamber Leadless Pacemaker Real-World Evidence Post-Approval Study

The purpose of this post-approval study is to evaluate the long-term safety of the single-chamber Aveir VR leadless pacemaker using real-world evidence methods.

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 assess Aveir VR leadless pacemaker safety in a large patient population. The results from this study will data to fulfill the Condition of Approval requirements for the Aveir VR device from FDA.

Eligibility Criteria:

• Implanted with an Aveir VR leadless pacemaker
• Continuous enrollment in Medicare Part A and Part B for 12 months prior to implant and for 30 days after implant, except in the case of death within the 30-day period
• Ability to link with Medicare fee-for-service data