Actively Recruiting
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
Eligibility Criteria
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
You will not qualify if you...
- N/A
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
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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