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Aveir VR Coverage With Evidence Development Post-Approval Study

Aveir Single-Chamber Leadless Pacemaker Coverage With Evidence Development (ACED) Post-Approval Study

Who can join

Ages 18 and older · All sexes

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 Criteria:

None

About the study

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).

What is being tested

• Aveir VR Leadless Pacemaker System (device)
• Single-Chamber Transvenous Pacemaker (device)

Sponsor: Abbott Medical Devices · Participants: 8,744 · Started: Jun 21, 2022

Contact the study team

• Nicole Harbert · Phone: 972-526-4841

Official record on ClinicalTrials.gov — NCT05336877

Locations in the U.S.

Conditions

• Arrhythmia
• Bradycardia

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.