Aveir VR Real-World Evidence Post-Approval Study

Recruiting

• Conditions: Arrythmia; Bradycardia; Cardiac Pacemaker
• Interventions: Device: Aveir VR Leadless Pacemaker System

• Registration Number: NCT05270499
• Lead Sponsor: Abbott Medical Devices

Brief 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.

Study Timeline

• Study First Submitted: 2022-02-28
• Study First Submitted QC: 2022-02-28
• Study First Posted: 2022-03-08
• Study Start: 2022-06-21
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-20
• Primary Completion: 2034-02-28
• Study Completion: 2034-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single Arm	Aveir VR Leadless Pacemaker System	Non randomized

Primary Outcome Measures

Name	Time	Method
Number of Subjects Free from Acute Aveir VR System-Related Complications	30 days	Freedom from complications through 30 days post implant procedure
Number of Subjects Free from Chronic Aveir VR System-Related Complications	10 Years	Freedom from Complications from 31 days through 10 years post implant procedure procedure

Secondary Outcome Measures

Name	Time	Method
Number of Subjects with End of Device Service Events	10 Years	Care of subjects at the end of device service. End-of-device service is defined as any event prior to the 10-year follow-up period which results in the leadless pacemaker being explanted or deactivated, another CIED implanted, or death. All instances of the end-of-service will be summarized by event type and time to event.
Number of Subjects Free from Individual Aveir VR Leadless Pacemaker-Related Complications	10 Years	Complication rate of the Aveir VR leadless pacemaker for individual acute and chronic complications

Trial Locations

Locations (1)

Abbott; 🇺🇸 Sylmar, California, United States