Aveir DR Real-World Evidence Post-Approval Study

Abbott

Status: Enrolling

Conditions: Bradycardia; Arrythmia; Cardiac Pacemaker

Treatments: Device: Aveir DR Leadless Pacemaker System

Study type: Observational

Funder types: Industry

Identifiers

NCT05935007

ABT-CIP-10454

Details and patient eligibility

About

The purpose of this post-approval study is to evaluate the long-term safety of the dual-chamber Aveir DR leadless pacemaker using real-world evidence methods.

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 assess Aveir DR leadless pacemaker safety in a large patient population. The results from this study will provide long-term safety data for the Aveir dual chamber LP and the Aveir atrial LP to fulfill the Condition of Approval requirements for the Aveir DR device from FDA.

Due to the RWE data collection methods used in this study, a central 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: 1,805 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Eligibility Criteria:

• Implanted with an Aveir DR leadless pacemaker
• Continuous enrollment in Medicare Part A and Part B for 12 months prior to implant and for -30 days after implant, except in the case of death within the 30-day period
• Ability to link with Medicare fee-for-service data

Trial design

1,805 participants in 1 patient group

Interventions

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 will be conducted in this study.

Treatment:

Device: Aveir DR Leadless Pacemaker System