Aveir Dual-Chamber Leadless Pacemaker Safety Study Using Real-World Data

What this Trial Is About

This research aims to evaluate the long-term safety of the Aveir dual-chamber leadless pacemaker in patients with cardiac pacemakers, arrhythmia, or bradycardia. It is an observational post-approval study designed to provide safety data by using real-world evidence methods and merging multiple data sets from Abbott and the Center for Medicare Services. This study fulfills FDA conditions of approval for the Aveir DR device. The study uses data from patients already implanted with the Aveir DR Leadless Pacemaker System, without performing any new device interventions. Data collection is based on real-world evidence and involves no randomization or treatment assignment. The study utilizes a central institutional review board approved waiver of informed consent, so individual hospitals do not need to obtain patient consent or conduct local IRB submissions. The focus is on monitoring safety outcomes over time. Participants are tracked through linked Medicare data to assess complications related to the device at both 30 days and over 5 years. The study measures the number of subjects free from acute and chronic device-related complications and records end-of-device service events. The total duration of follow-up extends up to five years, using real-world data to monitor long-term device safety and performance.

Aveir DR Real-World Evidence Post-Approval Study