Aveir VR Real-World Evidence Post-Approval Study

Abbott

Status: Enrolling

Conditions: Bradycardia; Arrythmia; Cardiac Pacemaker

Treatments: Device: Aveir VR Leadless Pacemaker System

Study type: Observational

Funder types: Industry

Identifiers

NCT05270499

ABT-CIP-10418

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

2,100 participants in 1 patient group

Single Arm

Description:

Non randomized

Treatment:

Device: Aveir VR Leadless Pacemaker System