Status:
RECRUITING
Aveir VR Real-World Evidence Post-Approval Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Cardiac Pacemaker
Arrythmia
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this post-approval study is to evaluate the long-term safety of the single-chamber Aveir VR leadless pacemaker using real-world evidence methods.
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 assess Aveir VR leadless...
Eligibility Criteria
Inclusion
- Eligibility Criteria:
- Implanted with an Aveir VR 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
Exclusion
Key Trial Info
Start Date :
June 21 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 28 2034
Estimated Enrollment :
2100 Patients enrolled
Trial Details
Trial ID
NCT05270499
Start Date
June 21 2022
End Date
February 28 2034
Last Update
August 20 2024
Active Locations (1)
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1
Abbott
Sylmar, California, United States, 91342