Aveir VR Real-World Evidence Post-Approval Study

Last updated: August 15, 2024
Sponsor: Abbott Medical Devices
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dysrhythmia

Low Blood Pressure (Hypotension)

Arrhythmia

Treatment

Aveir VR Leadless Pacemaker System

Clinical Study ID

NCT05270499
ABT-CIP-10418
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 2100
Treatment Group(s): 1
Primary Treatment: Aveir VR Leadless Pacemaker System
Phase:
Study Start date:
June 21, 2022
Estimated Completion Date:
February 28, 2034

Study 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.

Connect with a study center

  • Abbott

    Sylmar, California 91342
    United States

    Active - Recruiting

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