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AVEIR DR 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 dual chamber Aveir Leadless Pacemaker device (aka Aveir™ DR LP system).
Official title: The AVEIR DR Coverage With Evidence Development (DRIVE) Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
2812
Start Date
2023-10-31
Completion Date
2030-05
Last Updated
2025-04-06
Healthy Volunteers
No
Conditions
Interventions
Aveir DR Leadless Pacemaker System
This study will utilize real-world data from patients implanted with the Aveir DR Leadless Pacemaker System. No device intervention is required in this study.
Dual Chamber Transvenous Pacemaker
This study will utilize real-world data from patients implanted with a dual-chamber transvenous pacemaker as a comparator to the Aveir DR LP system study arm. No device intervention is required in this study.
Locations (1)
Abbott
Sylmar, California, United States