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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Aveir AR Coverage With Evidence Development (CED) Study
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Nicole Harbert · STUDY_DIRECTOR · Abbott
Who to contact
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Do you actually qualify for this trial?
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Exclusion
What this trial measures
- 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.