Aveir VR Coverage With Evidence Development Post-Approval Study (CED)

Abbott

Status: Enrolling

Conditions: Bradycardia; Arrythmia; Cardiac Pacemaker

Treatments: Device: Single-Chamber Transvenous Pacemaker; Device: Aveir VR Leadless Pacemaker System

Study type: Observational

Funder types: Industry

Identifiers

NCT05336877

ABT-CIP-10426

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 Single-Chamber Leadless Pacemaker device (Aveir VR LP).

Full 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.

Enrollment: 8,744 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

The study cohort will include all Medicare patients with continuous claims data implanted with an Aveir VR leadless pacemaker or a full-system single-chamber ventricular transvenous pacemaker (from any manufacturer) in any US location

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

Trial design

8,744 participants in 2 patient groups

Device: Aveir VR Leadless Pacemaker System

Description:

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.

Treatment:

Device: Aveir VR Leadless Pacemaker System

Device: Single-Chamber Transvenous Pacemaker

Description:

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.

Treatment:

Device: Single-Chamber Transvenous Pacemaker