RecruitingNCT05935007

Aveir DR Real-World Evidence Post-Approval Study

Aveir Dual-Chamber Leadless Pacemaker Real-World Evidence Post-Approval Study

Sponsor

Abbott Medical Devices

Enrollment

1,805 participants

Start Date

Oct 31, 2023

Study Type

OBSERVATIONAL

Conditions

Arrythmia Bradycardia Cardiac Pacemaker

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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

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Interventions

DEVICEAveir 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.