The purpose of this post-approval study is to evaluate the long-term safety of the single-chamber Aveir VR leadless pacemaker using real-world evidence methods.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Eligibility Criteria:
* Implanted with an Aveir VR leadless pacemaker
* Continuous enrollment in Medicare Part A and Part B for 12 months prior to implant and for 30 days after implant, except in the case of death within the 30-day period
* Ability to link with Medicare fee-for-service data
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is no longer actively enrolling, is there any other real-world evidence study for the Aveir VR leadless pacemaker that I might still be able to participate in, or would I just receive the device as part of standard care?
2This study is tracking how many patients stay free from both short-term and long-term complications with the Aveir VR system — based on what's been seen so far in this real-world study, what kinds of complications have been reported, and how does that compare to traditional pacemakers?
3Because this is a post-approval study happening in real-world clinical settings rather than a controlled trial, what does that mean for how confident we can be in the safety data being collected about this leadless pacemaker?
4Given that this study focuses on bradycardia and arrhythmia, is the Aveir VR leadless pacemaker actually the right type of device for my specific heart rhythm problem, or would a conventional pacemaker with leads be a better fit for my situation?
5How do the logistics of getting a leadless pacemaker like the Aveir VR differ from a standard pacemaker — for example, how does removal or replacement work if I need it down the road?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Subjects Free from Acute Aveir VR System-Related Complications
Timeframe: 30 days
2
Number of Subjects Free from Chronic Aveir VR System-Related Complications