Actively Recruiting
Aveir Leadless Pacemaker Japan Post Marketing Surveillance
Led by Abbott Medical Devices · Updated on 2026-05-13
304
Participants Needed
14
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to collect safety information on the Aveir DR leadless cardiac pacemaker system in patients who need new dual-chamber pacing. It also includes patients rolling over from a previous study and those needing upgrades from single-chamber to dual-chamber pacemakers. The study focuses on people implanted with leadless pacemakers in the right atrium or ventricle. Participants will receive one of several device-based interventions depending on their group: new dual-chamber leadless pacemaker implants with devices placed in the right ventricle and right atrium; single-chamber atrial leadless pacemaker implants; upgrades involving adding a second leadless pacemaker to form a dual-chamber system; or ongoing follow-up for patients already implanted with the Aveir DR leadless pacemaker. Patients are registered and followed until the last new dual-chamber patient reaches three years of follow-up. During the study, patients will be monitored for safety outcomes over 36 months. Data from different patient groups will be analyzed separately. Participants will have ongoing follow-up visits and evaluations to assess the performance and safety of their leadless pacemaker systems. The trial will continue until all new dual-chamber patients complete three years of observation to gather long-term safety information.
CONDITIONS
Brief 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...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants undergo implantation of a leadless pacemaker system, which may include a dual-chamber or single-chamber atrial device, or an upgrade to a dual-chamber system.
Follow-up visits until 3 years after implant
Duration - Up to 3 years
Participants with an implanted Aveir leadless pacemaker system are followed for ongoing safety and device performance monitoring.
Periodic follow-up visits until 3 years after implant
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
S
Stephanie Delgado
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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