Aveir AR Coverage With Evidence Development (CED) Study

Recruiting

• Conditions: Arrhythmia; Cardiac Pacemaker; Bradycardia
• Interventions: Device: Aveir AR Leadless Pacemaker; Device: Single-chamber atrial transvenous pacemaker

• Registration Number: NCT06100770
• 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 Atrial Leadless Pacemaker device (aka Aveir™ AR LP system).

Detailed Description

This CED study utilizes a real-world evidence (RWE) method merging multiple real-world datasets from Abbott and the Center for Medicare Services to assess Aveir AR LP health outcomes among Medicare beneficiaries.

The study will enroll all Medicare patients with continuous claims data implanted with the Aveir AR LP or a single-chamber atrial transvenous pacemaker system from any manufacturer.

Due to the RWE data collection methods used in this study, a central institutional review board (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: 2023-10-20
• Study First Submitted QC: 2023-10-20
• Study First Posted: 2023-10-25
• Study Start: 2024-01-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04
• Primary Completion: 2030-01
• Study Completion: 2031-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 586

Inclusion Criteria

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

   OR

2. Medicare beneficiaries implanted with a full system (e.g. lead and generator) single chamber atrial 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
Aveir AR Leadless Pacemaker	Aveir AR Leadless Pacemaker	This study will utilize real-world data from patients implanted with the Aveir AR Leadless Pacemaker. No device intervention is required in this study.
Single-Chamber Atrial Transvenous Pacemaker	Single-chamber atrial transvenous pacemaker	This study will utilize real-world data from patients implanted with a single-chamber atrial pacemaker as a comparator to the Aveir AR LP study arm. No device intervention is required in this study.

Primary Outcome Measures

Name	Time	Method
Acute device-related complication rate	30 days	Assess the acute (30-day) complication rate of the Aveir AR LP, compared to single chamber atrial transvenous pacemakers. An acute complication is defined as a peri-procedural, device-related adverse event occurring within 30 days post-implant.
Two-year survival rate	2 years	Assess (2-year) survival rate of subjects implanted with an Aveir AR LP, compared to single chamber atrial transvenous pacemakers.

Secondary Outcome Measures

Name	Time	Method
Device related re-intervention rate	2 years	• To assess (2-year) device-related re-intervention rates of the Aveir AR LP, compared to single chamber atrial transvenous pacemakers.
Chronic complication rate	6 months	• To assess the chronic (6-month) complication rate of the Aveir AR LP, compared to single chamber atrial transvenous pacemakers. A chronic complication is defined as a post-procedural, device-related adverse event that requires invasive intervention to resolve, occurring more than 30 days through six months post implant.

Trial Locations

Locations (1)

Abbott; 🇺🇸 Sylmar, California, United States