Aveir DR Real-World Evidence Post-Approval Study

Recruiting

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

• Registration Number: NCT05935007
• Lead Sponsor: Abbott Medical Devices

Brief 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.

Study Timeline

• Study First Submitted: 2023-05-24
• Study First Submitted QC: 2023-07-05
• Study First Posted: 2023-07-07
• Study Start: 2023-10-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04
• Primary Completion: 2030-01
• Study Completion: 2030-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1805

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Interventions	Aveir DR Leadless Pacemaker System	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.

Primary Outcome Measures

Name	Time	Method
Number of Subjects Free from Chronic Aveir DR System-Related Complications	5 Years	Freedom from key chronic complications from 31 days through 5 years post implant procedure procedure
Number of Subjects Free from Acute Aveir DR System-Related Complications	30 Days	Freedom from key acute complications through 30 days post implant procedure

Secondary Outcome Measures

Name	Time	Method
Number of Subjects with End of Device Service Events	5 Years	Care of subjects at the end of device service. End-of-device service is defined as any event prior to the 5-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 DR Leadless Pacemaker-Related	5 Years	Complication rate of the Aveir DR leadless pacemaker for key individual acute and chronic complications

Trial Locations

Locations (1)

Abbott; 🇺🇸 Sylmar, California, United States