NCT05270499

Aveir VR Real-World Evidence Post-Approval Study

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,100 (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 single-chamber Aveir VR 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 VR leadless pacemaker safety in a large patient population. The results from this study will data to fulfill the Condition of Approval requirements for the Aveir VR device from FDA.

Conditions

• Cardiac Pacemaker
• Arrythmia
• Bradycardia

Interventions

Type	Name	Description
DEVICE	Aveir VR Leadless Pacemaker System	This study will utilize real-world data from patients implanted with the Aveir VR Leadless Pacemaker System. No device intervention will be conducted in this study.

Timeline

• Start date: 2022-06-21
• Primary completion: 2034-02-28
• Completion: 2034-02-28
• First posted: 2022-03-08
• Last updated: 2024-08-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study