AVEIR DR Coverage With Evidence Development (CED) 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
- 2,812 (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 dual chamber Aveir Leadless Pacemaker device (aka Aveir™ DR LP system).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Medicare beneficiaries implanted with an Aveir DR leadless pacemaker on or after the study start date (i.e., the date of Aveir DR market approval) will be included in the study.
OR
Medicare beneficiaries implanted with a full system (e.g. lead and generator) dual-chamber tra…
Contacts