Aveir Single-Chamber Leadless Pacemaker Real-World Evidence Post-Approval Study
Abbott Medical Devices
Summary
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.
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 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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DeviceAveir VR Leadless Pacemaker System
This study will utilize real-world data from patients implanted with the Aveir VR Leadless Pacemaker System. No device intervention will be conducted in this study.
Location
- AbbottSylmar, California