Aveir DR Leadless Pacemaker Safety Study
This study is looking at the long-term safety of the Aveir DR Leadless Pacemaker System, a device used for heart conditions like arrhythmia (irregular heartbeat) and bradycardia (slow heart rate). You could be eligible if you have already had an Aveir DR leadless pacemaker implanted and have been continuously enrolled in Medicare Part A and Part B for a specific period. The study will measure how many people are free from device-related problems after 30 days and again after 5 years. The current status of this study is unclear.
- Study design
- This is an observational study that will use real-world data from about 1805 participants. It is not randomized and involves multiple centers.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 5 years to assess long-term safety.
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 Real-World Evidence Post-Approval 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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What this trial measures
- Number of Subjects Free from Acute Aveir DR System-Related Complications30 Days
Freedom from key acute complications through 30 days post implant procedure
- Number of Subjects Free from Chronic Aveir DR System-Related Complications5 Years
Freedom from key chronic complications from 31 days through 5 years post implant procedure procedure