NCT05336877

Aveir VR Coverage With Evidence Development Post-Approval Study

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 8,744 (estimated)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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 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.

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 is required in this study.
DEVICE	Single-Chamber Transvenous Pacemaker	This study will utilize real-world data from patients implanted with a single-chamber transvenous pacemaker as a comparator to the Aveir VR LP system study arm. No device intervention is required in this study.

Timeline

• Start date: 2022-06-21
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2022-04-20
• Last updated: 2025-07-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study