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Aveir VR Coverage With Evidence Development Post-Approval Study
Sponsor: Abbott Medical Devices
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 (Aveir VR LP).
Official title: Aveir Single-Chamber Leadless Pacemaker Coverage With Evidence Development (ACED) Post-Approval Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
8744
Start Date
2022-06-21
Completion Date
2028-01-01
Last Updated
2025-07-31
Healthy Volunteers
No
Conditions
Interventions
Aveir VR Leadless Pacemaker System
This study will utilize real-world data from patients implanted with the Aveir VR Leadless Pacemaker System. No device intervention is required in this study.
Single-Chamber Transvenous Pacemaker
This study will utilize real-world data from patients implanted with a single-chamber transvenous pacemaker as a comparator to the Aveir VR LP system study arm. No device intervention is required in this study.
Locations (1)
Abbott
Sylmar, California, United States