Aveir AR Coverage With Evidence Development (CED) Study (ARRIVE)

Abbott

Status: Enrolling

Conditions: Bradycardia; Arrhythmia; Cardiac Pacemaker

Treatments: Device: Aveir AR Leadless Pacemaker; Device: Single-chamber atrial transvenous pacemaker

Study type: Observational

Funder types: Industry

Identifiers

NCT06100770

ABT-CIP-CL1021378

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 single-chamber Aveir Atrial Leadless Pacemaker device (aka Aveir™ AR 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 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.

Enrollment: 586 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

586 participants in 2 patient groups

Aveir AR Leadless Pacemaker

Description:

This study will utilize real-world data from patients implanted with the Aveir AR Leadless Pacemaker. No device intervention is required in this study.

Treatment:

Device: Aveir AR Leadless Pacemaker

Single-Chamber Atrial Transvenous Pacemaker

Description:

This study will utilize real-world data from patients implanted with a single-chamber atrial transvenous pacemaker as a comparator to the Aveir AR LP study arm. No device intervention is required in this study.

Treatment:

Device: Single-chamber atrial transvenous pacemaker