Aveir VR Coverage With Evidence Development 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
- 8,744 (estimated)
- Sponsor
- Abbott Medical Devices · Industry
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About This Trial
The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the single-chamber Aveir Single-Chamber Leadless Pacemaker device (Aveir VR LP).
Trial Locations
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Eligibility Criteria
The study cohort will include all Medicare patients with continuous claims data implanted with an Aveir VR leadless pacemaker or a full-system single-chamber ventricular transvenous pacemaker (from any manufacturer) in any US location
Inclusion Criteria:
Medicare beneficiaries implanted with an Av…
Contacts