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Clinical Trial 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 Aveirâ„¢ DR LP system).


Clinical Trial Description

This CED study utilizes a real-world evidence (RWE) method merging multiple real-world datasets from Abbott and the Center for Medicare Services to assess Aveir DR LP health outcomes among Medicare beneficiaries. The study will enroll all Medicare patients with continuous claims data implanted with the Aveir DR LP system or a dual-chamber transvenous pacemaker system from any manufacturer. Due to the RWE data collection methods used in this study, a central institutional review board (IRB) approved informed consent waiver has been granted. Due to this waiver and the sponsor's use of the central IRB, individual hospitals are not required to consent patients or complete local IRB submissions for this RWE study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05932602
Study type Observational
Source Abbott Medical Devices
Contact Nicole Harbert
Phone 972-526-4841
Email nicole.harbert@abbott.com
Status Recruiting
Phase
Start date October 31, 2023
Completion date October 2025

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