Aveir DR Real-World Evidence Post-Approval Study
Recruiting
Observational Study
Cardiac Pacemaker
Arrythmia
Bradycardia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 1,805 (estimated)
- Sponsor
- Abbott Medical Devices · Industry
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About This Trial
The purpose of this post-approval study is to evaluate the long-term safety of the dual-chamber Aveir DR leadless pacemaker using real-world evidence methods.
Trial Locations
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Eligibility Criteria
Eligibility Criteria:
* Implanted with an Aveir DR 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
Contacts