Status:
RECRUITING
Aveir AR Coverage With Evidence Development (CED) Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Cardiac Pacemaker
Arrhythmia
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the single-chamber Aveir Atrial Leadless Pacemaker device (aka Aveir™ A...
Detailed Description
This CED study utilizes a real-world evidence (RWE) method merging multiple real-world datasets from Abbott and the Center for Medicare Services to assess Aveir AR LP health outcomes among Medicare be...
Eligibility Criteria
Inclusion
- Medicare beneficiaries implanted with an Aveir AR leadless pacemaker on or after the study start date (i.e., the date of Aveir AR market approval) will be included in the study.
- OR
- Medicare beneficiaries implanted with a full system (e.g. lead and generator) single chamber atrial transvenous pacemaker on or after the study start date
Exclusion
- None
Key Trial Info
Start Date :
January 18 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2031
Estimated Enrollment :
586 Patients enrolled
Trial Details
Trial ID
NCT06100770
Start Date
January 18 2024
End Date
January 1 2031
Last Update
April 4 2025
Active Locations (1)
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1
Abbott
Sylmar, California, United States, 91342