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Aveir AR Coverage With Evidence Development (CED) 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 Atrial Leadless Pacemaker device (aka Aveir™ AR LP system).
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
586
Start Date
2024-01-18
Completion Date
2031-01
Last Updated
2025-04-04
Healthy Volunteers
No
Conditions
Interventions
Aveir AR Leadless Pacemaker
This study will utilize real-world data from patients implanted with the Aveir AR Leadless Pacemaker. No device intervention is required in this study.
Single-chamber atrial transvenous pacemaker
This study will utilize real-world data from patients implanted with a single-chamber atrial transvenous pacemaker as a comparator to the Aveir AR LP study arm. No device intervention is required in this study
Locations (1)
Abbott
Sylmar, California, United States