AVEIR DR Coverage With Evidence Development (CED) Study

Abbott

Status: Enrolling

Conditions: Bradycardia; Arrythmia; Cardiac Pacemaker

Treatments: Device: Aveir DR Leadless Pacemaker System; Device: Dual Chamber Transvenous Pacemaker

Study type: Observational

Funder types: Industry

Identifiers

NCT05932602

ABT-CIP-1020548

Details and patient eligibility

About

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).

Full 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.

Enrollment: 2,812 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

OR

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

Exclusion criteria

None

Trial design

2,812 participants in 2 patient groups

Aveir DR Leadless Pacemaker System

Description:

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.

Treatment:

Device: Aveir DR Leadless Pacemaker System

Dual Chamber Transvenous Pacemaker

Description:

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.

Treatment:

Device: Dual Chamber Transvenous Pacemaker