Aveir DR Leadless Pacemaker Study for Medicare Beneficiaries
This study is looking at how well the Aveir DR Leadless Pacemaker System works and its long-term health effects compared to a traditional dual-chamber pacemaker. Researchers will use existing health information from Medicare patients who have received either the Aveir DR Leadless Pacemaker or a standard dual-chamber pacemaker. The study aims to understand the rate of device-related complications within 30 days and how long patients survive after two years. You could be included if you are a Medicare beneficiary who received either of these pacemakers on or after the study's start date. This study uses real-world data, so you won't need to do anything extra.
- Study design
- This is an observational study that will look at health data from approximately 2,812 Medicare beneficiaries. It compares patients who received the Aveir DR Leadless Pacemaker to those who received a dual-chamber transvenous pacemaker.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track acute device-related complications for 30 days and patient survival for two years.
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 DR 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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Inclusion
What this trial measures
- Acute device related complication rate30 days
Assess the acute (30-day) complication rate of the Aveir DR LP, compared to dual chamber 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 DR LP, compared to dual chamber transvenous pacemakers.