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Aveir VR Coverage With Evidence Development Post-Approval Study — CED  

Bradycardia Clinical Trial

Official title:
Aveir Single-Chamber Leadless Pacemaker Coverage With Evidence Development (ACED) Post-Approval Study

Clinical Trial 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).

Clinical Trial 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 safety and health outcomes to those in patients implanted with single-chamber transvenous pacemakers in a large patient population. The study will enroll all Medicare patients implanted with the Aveir VR LP and, as the control group, patients implanted with a single-chamber ventricular transvenous pacemaker from any manufacturer. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05336877
Study type Observational
Source Abbott Medical Devices
Contact Grant Kim
Phone 818-493-3147
Email Grant.kim1@abbott.com
Status Recruiting
Phase
Start date June 21, 2022
Completion date January 1, 2028
View Details
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