Aveir DR Real-World Evidence Post-Approval Study

Bradycardia Clinical Trial

Official title: Aveir Dual-Chamber Leadless Pacemaker Real-World Evidence Post-Approval Study

Status Recruiting

Clinical Trial Summary

The purpose of this post-approval study is to evaluate the long-term safety of the dual-chamber Aveir DR leadless pacemaker using real-world evidence methods.

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 assess Aveir DR leadless pacemaker safety in a large patient population. The results from this study will provide long-term safety data for the Aveir dual chamber LP and the Aveir atrial LP to fulfill the Condition of Approval requirements for the Aveir DR device from FDA.

Due to the RWE data collection methods used in this study, a central 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. ;

Related Conditions & MeSH terms

• Arrythmia
• Bradycardia
• Cardiac Pacemaker

• NCT number: NCT05935007
• Study type: Observational
• Source: Abbott Medical Devices
• Contact: Nicole Harbert
• Phone: 972-526-4841
• Email: nicole.harbert@abbott.com
• Status: Recruiting
• Start date: October 31, 2023
• Completion date: January 2030