NCT05932602

AVEIR DR Coverage With Evidence Development (CED) Study

The AVEIR DR Coverage With Evidence Development (DRIVE) Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,812 (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 dual chamber Aveir Leadless Pacemaker device (aka Aveir™ DR 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 DR LP health outcomes among Medicare beneficiaries. The study will enroll all Medicare patients with continuous claims data implanted with the Aveir DR LP system or a dual-chamber 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.

Conditions

• Cardiac Pacemaker
• Arrythmia
• Bradycardia

Interventions

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

Timeline

• Start date: 2023-10-31
• Primary completion: 2029-05-01
• Completion: 2030-05-01
• First posted: 2023-07-06
• Last updated: 2025-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study