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Aveir Leadless Pacemaker Japan PMS
Sponsor: Abbott Medical Devices
Summary
The primary purpose of the PMS is to collect safety information on the Aveir DR leadless cardiac pacemaker (LP) system in a population indicated for de novo dual-chamber pacing. Additionally, the PMS will collect data on rollover patients from the Aveir DR i2i IDE, Aveir AR LP in patients indicated for single-chamber pacing in the right atrium, and upgradeability in patients implanted with single-chamber Aveir atrial or ventricular LP that require an upgrade to a dual-chamber Aveir LP.
Official title: Aveir Leadless Pacemaker Japan Post Marketing Surveillance
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
304
Start Date
2025-05-26
Completion Date
2029-11
Last Updated
2025-08-28
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (9)
Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan
St. Marianna University School of Medicine Hospital
Kawasaki, Kanagwa, Japan
Sendai Kousei Hospital
Sendai, Miyagi, Japan
Kurashiki Central Hospital
Kurashiki, Okayama-ken, Japan
Osaka Keisatsu Hospital
Osaka, Osaka, Japan
National Cerebral & Cardiovascular Center Hospital
Suita, Osaka, Japan
Juntendo University Shizuoka Hospital
Izunokuni, Shizuok, Japan
Tokyo Medical University Hospital
Tokyo, Tokyo, Japan
Tokyo Women's Hospital
Tokyo, Tokyo, Japan