Aveir VR Coverage With Evidence Development Post-Approval Study

Recruiting

• Conditions: Arrythmia; Bradycardia; Cardiac Pacemaker
• Interventions: Device: Aveir VR Leadless Pacemaker System; Device: Single-Chamber Transvenous Pacemaker

• Registration Number: NCT05336877
• Lead Sponsor: Abbott Medical Devices

Brief 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.

Study Timeline

• Study First Submitted: 2022-04-11
• Study First Submitted QC: 2022-04-19
• Study First Posted: 2022-04-20
• Study Start: 2022-06-21
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-14
• Primary Completion: 2028-01-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 8744

Inclusion Criteria

Medicare beneficiaries implanted with an Aveir VR leadless pacemaker on or after the study start date (i.e., the date of Aveir VR market approval) will be included in the study.

OR

Medicare beneficiaries implanted with a full system (e.g. lead and generator) single-chamber ventricular transvenous pacemaker on or after the study start date

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Device: Aveir VR Leadless Pacemaker System	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	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.

Primary Outcome Measures

Name	Time	Method
Number of Subjects with Acute Device-Related Complications	30 days	Rate of acute complications in subjects implanted with an Aveir VR LP compared to subjects implanted with a single-chamber ventricular transvenous pacemaker. Acute complications are defined as a peri-procedural, device-related adverse event within 30 days post-implant.
Number of Subjects Alive after 2 Years	2 years	The 2-year survival rate of subjects implanted with an Aveir VR LP compared with subjects implanted with single-chamber ventricular transvenous pacemaker.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects with Chronic Device-Related Complications	6 months	Rate of chronic complications in subjects implanted with Aveir VR LP compared with subjects implanted with a single-chamber ventricular transvenous pacemaker, from 31 days through six months post implant procedure. A chronic complication is defined as a post-procedural, device-related adverse event that requires invasive intervention to resolve.
Number of Subjects with a Device-Related Re-Intervention	2 years	Rate of device-related re-intervention in subjects implanted with an Aveir VR LP compared to subjects implanted with a single-chamber ventricular transvenous pacemaker, through 2 years post implant procedure.

Trial Locations

Locations (1)

Abbott; 🇺🇸 Sylmar, California, United States