Actively Recruiting

All Genders
NCT07106788

Aveir Leadless Pacemaker Japan PMS

Led by Abbott Medical Devices · Updated on 2026-05-13

304

Participants Needed

14

Research Sites

231 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Aveir Leadless Pacemaker Japan PMS

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is indicated for dual-chamber or single-chamber atrial leadless pacemaker system
  • Patient is a roll-over patient with existing Aveir DR leadless pacemaker system from the Aveir DR i2i IDE study
  • Patient is an upgrade patient with existing single-chamber Aveir leadless pacemaker that requires an upgrade to a dual-chamber Aveir leadless pacemaker system
Not Eligible

You will not qualify if you...

  • N/A

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 14 locations

1

Nagoya University Hospital

Nagoya, Aichi-ken, Japan, 466-8550

Actively Recruiting

2

Kokura Memorial Hospital

Kitakyushu, Fukuoka, Japan, 802-8555

Actively Recruiting

3

St. Marianna University School of Medicine Hospital

Kawasaki, Kanagwa, Japan, 2168511

Actively Recruiting

4

Sendai Kousei Hospital

Sendai, Miyagi, Japan, 981-0914

Actively Recruiting

5

Kurashiki Central Hospital

Kurashiki, Okayama-ken, Japan, 710-0052

Actively Recruiting

6

Kansai Medical University Hospital

Hirakata, Osaka, Japan, 573-1191

Actively Recruiting

7

Osaka Keisatsu Hospital

Osaka, Osaka, Japan, 543-8922

Actively Recruiting

8

National Cerebral & Cardiovascular Center Hospital

Suita, Osaka, Japan, 564-8565

Actively Recruiting

9

Juntendo University Shizuoka Hospital

Izunokuni, Shizuok, Japan, 410-2295

Actively Recruiting

10

Toho University - Omori Medical Center

Ōta-ku, Tokyo, Japan, 143-8541

Actively Recruiting

11

Showa Medical University Hospital

Shinagawa-ku, Tokyo, Japan, 142-8666

Actively Recruiting

12

Chiba University Hospital

Chiba, Japan, 260-8677

Actively Recruiting

13

Tokyo Medical University Hospital

Tokyo, Japan, 160-0023

Actively Recruiting

14

Tokyo Women's Hospital

Tokyo, Japan, 162-8666

Actively Recruiting

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Research Team

M

Mieko Otake

CONTACT

S

Stephanie Delgado

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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