AVEIR DR Coverage With Evidence Development (CED) Study

Last updated: April 3, 2025
Sponsor: Abbott Medical Devices
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cardiac Disease

Arrhythmia

Dysrhythmia

Treatment

Aveir DR Leadless Pacemaker System

Dual Chamber Transvenous Pacemaker

Clinical Study ID

NCT05932602
ABT-CIP-1020548
  • Ages > 18
  • All Genders

Study Summary

The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the dual chamber Aveir Leadless Pacemaker device (aka Aveir™ DR LP system).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Medicare beneficiaries implanted with an Aveir DR leadless pacemaker on or after thestudy start date (i.e., the date of Aveir DR market approval) will be included inthe study.

OR

Medicare beneficiaries implanted with a full system (e.g. lead and generator) dual-chamber transvenous pacemaker on or after the study start date

Exclusion

Exclusion Criteria:

None

Study Design

Total Participants: 2812
Treatment Group(s): 2
Primary Treatment: Aveir DR Leadless Pacemaker System
Phase:
Study Start date:
October 31, 2023
Estimated Completion Date:
May 31, 2030

Study Description

This CED study utilizes a real-world evidence (RWE) method merging multiple real-world datasets from Abbott and the Center for Medicare Services to assess Aveir DR LP health outcomes among Medicare beneficiaries.

The study will enroll all Medicare patients with continuous claims data implanted with the Aveir DR LP system or a dual-chamber transvenous pacemaker system from any manufacturer.

Due to the RWE data collection methods used in this study, a central institutional review board (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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