NCT05935007

Aveir DR Real-World Evidence Post-Approval Study

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,805 (estimated)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cardiac Pacemaker
• Arrythmia
• Bradycardia

Interventions

Type	Name	Description
DEVICE	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 will be conducted in this study.

Timeline

• Start date: 2023-10-31
• Primary completion: 2030-01-01
• Completion: 2030-01-01
• First posted: 2023-07-07
• Last updated: 2025-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study