Aveir Leadless Pacemaker Japan PMS

RecruitingOBSERVATIONAL
Enrollment

304

Participants

Timeline

Start Date

May 26, 2025

Primary Completion Date

November 30, 2029

Study Completion Date

November 30, 2029

Conditions
Leadless Pacemaker
Interventions
DEVICE

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

DEVICE

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

DEVICE

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.

DEVICE

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.

Trial Locations (9)

2168511

RECRUITING

St. Marianna University School of Medicine Hospital, Kawasaki

802-8555

RECRUITING

Kokura Memorial Hospital, Kitakyushu

981-0914

RECRUITING

Sendai Kousei Hospital, Sendai

710-0052

RECRUITING

Kurashiki Central Hospital, Kurashiki

543-8922

RECRUITING

Osaka Keisatsu Hospital, Osaka

564-8565

RECRUITING

National Cerebral & Cardiovascular Center Hospital, Suita

410-2295

RECRUITING

Juntendo University Shizuoka Hospital, Izunokuni

160-0023

RECRUITING

Tokyo Medical University Hospital, Tokyo

162-8666

RECRUITING

Tokyo Women's Hospital, Tokyo

Sponsors
All Listed Sponsors
lead

Abbott Medical Devices

INDUSTRY