Aveir VR Coverage With Evidence Development Post-Approval Study

Last updated: June 12, 2024
Sponsor: Abbott Medical Devices
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Defect

Heart Disease

Low Blood Pressure (Hypotension)

Treatment

Single-Chamber Transvenous Pacemaker

Aveir VR Leadless Pacemaker System

Clinical Study ID

NCT05336877
ABT-CIP-10426
  • 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 Single-Chamber Leadless Pacemaker device (Aveir VR LP).

Eligibility Criteria

Inclusion

The study cohort will include all Medicare patients with continuous claims data implanted with an Aveir VR leadless pacemaker or a full-system single-chamber ventricular transvenous pacemaker (from any manufacturer) in any US location

Inclusion Criteria:

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

OR

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

Exclusion

Exclusion Criteria:

None

Study Design

Total Participants: 8744
Treatment Group(s): 2
Primary Treatment: Single-Chamber Transvenous Pacemaker
Phase:
Study Start date:
June 21, 2022
Estimated Completion Date:
January 01, 2028

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 compare Aveir VR LP safety and health outcomes to those in patients implanted with single-chamber transvenous pacemakers in a large patient population.

The study will enroll all Medicare patients implanted with the Aveir VR LP and, as the control group, patients implanted with a single-chamber ventricular transvenous pacemaker from any manufacturer.

Connect with a study center

  • Abbott

    Sylmar, California 91342
    United States

    Active - Recruiting

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