304
Participants
Start Date
May 26, 2025
Primary Completion Date
November 30, 2029
Study Completion Date
November 30, 2029
Aveir DR Leadless Pacemaker Implant
Patients will undergo a dual chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right ventricle and right atrium
Single-chamber atrial Aveir patients
Patients will undergo a single chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right atrium
Upgrades
Patients with an existing single-chamber leadless pacemaker will undergo a leadless pacemaker system implant wherein an additional leadless pacemaker will be implanted in either the right ventricle or right atrium to form a dual-chamber LP system.
Roll-over
Patients with an existing active Aveir DR leadless pacemaker system are eligible to be rolled into the Aveir Japan PMS upon consent for ongoing follow-up.
RECRUITING
St. Marianna University School of Medicine Hospital, Kawasaki
RECRUITING
Kokura Memorial Hospital, Kitakyushu
RECRUITING
Sendai Kousei Hospital, Sendai
RECRUITING
Kurashiki Central Hospital, Kurashiki
RECRUITING
Osaka Keisatsu Hospital, Osaka
RECRUITING
National Cerebral & Cardiovascular Center Hospital, Suita
RECRUITING
Juntendo University Shizuoka Hospital, Izunokuni
RECRUITING
Tokyo Medical University Hospital, Tokyo
RECRUITING
Tokyo Women's Hospital, Tokyo
Lead Sponsor
Abbott Medical Devices
INDUSTRY