Aveir DR Real-World Evidence Post-Approval Study

Last updated: April 2, 2025
Sponsor: Abbott Medical Devices
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Defect

Low Blood Pressure (Hypotension)

Heart Disease

Treatment

Aveir DR Leadless Pacemaker System

Clinical Study ID

NCT05935007
ABT-CIP-10454
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Eligibility Criteria:

  • Implanted with an Aveir DR 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: 1805
Treatment Group(s): 1
Primary Treatment: Aveir DR Leadless Pacemaker System
Phase:
Study Start date:
October 31, 2023
Estimated Completion Date:
January 31, 2030

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 DR leadless pacemaker safety in a large patient population. The results from this study will provide long-term safety data for the Aveir dual chamber LP and the Aveir atrial LP to fulfill the Condition of Approval requirements for the Aveir DR device from FDA.

Due to the RWE data collection methods used in this study, a central IRB approved informed consent waiver has been granted. Due to this waiver and the sponsor's use of the central IRB, individual hospitals are not required to consent patients or complete local IRB submissions for this RWE study.

Connect with a study center

  • Abbott

    Sylmar, California 91342
    United States

    Active - Recruiting

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