Status:
RECRUITING
Aveir VR Coverage With Evidence Development Post-Approval Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Cardiac Pacemaker
Arrythmia
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 Single-Chamber Leadless Pacemaker device (Avei...
Detailed Description
This is a non-randomized, multi-center study leveraging real-world evidence methods that merge multiple real-world datasets from Abbott and the Center for Medicare Services to compare Aveir VR LP safe...
Eligibility Criteria
Inclusion
- 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
- Medicare beneficiaries implanted with an Aveir VR leadless pacemaker on or after the study start date (i.e., the date of Aveir VR market approval) will be included in the study.
- OR
- Medicare beneficiaries implanted with a full system (e.g. lead and generator) single-chamber ventricular transvenous pacemaker on or after the study start date
Exclusion
- None
Key Trial Info
Start Date :
June 21 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
8744 Patients enrolled
Trial Details
Trial ID
NCT05336877
Start Date
June 21 2022
End Date
January 1 2028
Last Update
July 31 2025
Active Locations (1)
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1
Abbott
Sylmar, California, United States, 91342