Aveir AR Coverage With Evidence Development (CED) Study

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

Phase

N/A

Condition

Heart Defect

Cardiac Disease

Heart Disease

Treatment

Aveir AR Leadless Pacemaker

Single-chamber atrial transvenous pacemaker

Clinical Study ID

NCT06100770
ABT-CIP-CL1021378
  • 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 single-chamber Aveir Atrial Leadless Pacemaker device (aka Aveir™ AR LP system).

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

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

Exclusion

Exclusion Criteria:

  • None

Study Design

Total Participants: 586
Treatment Group(s): 2
Primary Treatment: Aveir AR Leadless Pacemaker
Phase:
Study Start date:
January 18, 2024
Estimated Completion Date:
January 31, 2031

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 AR LP health outcomes among Medicare beneficiaries.

The study will enroll all Medicare patients with continuous claims data implanted with the Aveir AR LP or a single-chamber atrial 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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