Aveir AR Leadless Pacemaker Study for Medicare Beneficiaries

This study is looking at the Aveir AR Leadless Pacemaker, a small device for people with heart rhythm problems (arrhythmia) like a slow heartbeat (bradycardia). It's also comparing it to a standard single-chamber atrial transvenous pacemaker. Researchers want to understand how safe and effective the Aveir AR Leadless Pacemaker is by looking at real-world health information from Medicare beneficiaries. They will check for device-related complications within 30 days and how long people survive over two years. You might be included if you are a Medicare beneficiary who received an Aveir AR Leadless Pacemaker or a single-chamber atrial transvenous pacemaker after the study started. The study aims to include 586 people, but its current status is unclear.

Study design
This is an observational study, meaning researchers will look at existing health data rather than giving you a new treatment. It plans to include 586 Medicare beneficiaries.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will look at your health outcomes for up to two years after your pacemaker implantation.

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NCT06100770

Aveir AR Coverage With Evidence Development (CED) Study

Recruiting
Not specifiedAges 18+Observational
Abbott Medical Devices
~586 participants
Updated 2025-04-04 on ClinicalTrials.gov
What's tested:Aveir AR Leadless PacemakerSingle-chamber atrial transvenous pacemaker

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Acute device-related complication rate
Measured over 30 days
+1 more outcome measured
Cardiac Pacemaker
Arrhythmia
Bradycardia
1 sites across 1 states
California1
  • Nicole Harbert · STUDY_DIRECTOR · Abbott

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Eligibility criteria

Exclusion

None
  • Acute device-related complication rate30 days

    Assess the acute (30-day) complication rate of the Aveir AR LP, compared to single chamber atrial transvenous pacemakers. An acute complication is defined as a peri-procedural, device-related adverse event occurring within 30 days post-implant.

  • Two-year survival rate2 years

    Assess (2-year) survival rate of subjects implanted with an Aveir AR LP, compared to single chamber atrial transvenous pacemakers.