Safety Monitoring of Aveir Leadless Pacemaker Systems in Japan Including Dual-Chamber, Single-Chamber Atrial, and Upgrade Patients

What this Trial Is About

This research aims to collect safety information on the Aveir DR leadless cardiac pacemaker system in patients who need new dual-chamber pacing. It also includes patients rolling over from a previous study and those needing upgrades from single-chamber to dual-chamber pacemakers. The study focuses on people implanted with leadless pacemakers in the right atrium or ventricle. Participants will receive one of several device-based interventions depending on their group new dual-chamber leadless pacemaker implants with devices placed in the right ventricle and right atrium single-chamber atrial leadless pacemaker implants upgrades involving adding a second leadless pacemaker to form a dual-chamber system or ongoing follow-up for patients already implanted with the Aveir DR leadless pacemaker. Patients are registered and followed until the last new dual-chamber patient reaches three years of follow-up. During the study, patients will be monitored for safety outcomes over 36 months. Data from different patient groups will be analyzed separately. Participants will have ongoing follow-up visits and evaluations to assess the performance and safety of their leadless pacemaker systems. The trial will continue until all new dual-chamber patients complete three years of observation to gather long-term safety information.

Aveir Leadless Pacemaker Japan PMS