Aveir Leadless Dual-Chamber Pacemaker Post-Marketing Surveillance in Japan

Aveir Leadless Pacemaker Japan Post Marketing Surveillance

This project will collect safety information on the Aveir DR leadless pacemaker for patients in Japan who need new dual-chamber pacing, upgrades from single-chamber devices, or who rolled over from an earlier Aveir trial.

Quick facts

• Study type: Observational
• Enrollment: 304 (estimated)
• Sex: All
• Sponsor: Abbott Medical Devices (Industry-sponsored)
• Locations: 14 sites (Nagoya, Aichi-ken and 13 other locations)
• Trial ID: NCT07106788 on ClinicalTrials.gov

What this trial studies

This post-marketing surveillance program will collect real-world safety and device performance data for the Aveir DR leadless cardiac pacemaker system in patients indicated for de novo dual-chamber pacing, selected single-chamber atrial implants, and upgrades from existing Aveir devices. Enrolled participants include de novo dual-chamber candidates, roll-over patients from the Aveir DR i2i IDE, and patients requiring upgrade from single-chamber Aveir atrial or ventricular devices. Implantation and follow-up occur at participating Japanese centers with scheduled clinical visits and device checks to capture adverse events, device performance metrics, and long-term outcomes. The data are observational and intended to characterize safety and practical device use in routine clinical practice.

Who should consider this trial

Good fit: Ideal candidates are adults in Japan indicated for dual-chamber leadless pacing, roll-over participants from the Aveir DR i2i IDE, or patients with existing single-chamber Aveir devices who require upgrade to a dual-chamber system.

Not a fit: Patients who are not candidates for leadless pacing — for example those requiring traditional transvenous systems, with relevant anatomical constraints, or with contraindications — are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the data could clarify real-world safety and performance of the Aveir dual-chamber leadless pacemaker and help clinicians choose appropriate patients.

How similar studies have performed: Prior studies of single-chamber leadless pacemakers have shown safety and effectiveness, while dual-chamber leadless systems like Aveir have more limited but promising early data.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* N/A

Where this trial is running

Nagoya, Aichi-ken and 13 other locations

• Nagoya University Hospital — Nagoya, Aichi-ken, Japan (Recruiting)
• Kokura Memorial Hospital — Kitakyushu, Fukuoka, Japan (Recruiting)
• St. Marianna University School of Medicine Hospital — Kawasaki, Kanagwa, Japan (Recruiting)
• Sendai Kousei Hospital — Sendai, Miyagi, Japan (Recruiting)
• Kurashiki Central Hospital — Kurashiki, Okayama-ken, Japan (Recruiting)
• Kansai Medical University Hospital — Hirakata, Osaka, Japan (Recruiting)
• Osaka Keisatsu Hospital — Osaka, Osaka, Japan (Recruiting)
• National Cerebral & Cardiovascular Center Hospital — Suita, Osaka, Japan (Recruiting)
• Juntendo University Shizuoka Hospital — Izunokuni, Shizuok, Japan (Recruiting)
• Toho University - Omori Medical Center — Ōta-ku, Tokyo, Japan (Recruiting)
• Showa Medical University Hospital — Shinagawa-ku, Tokyo, Japan (Recruiting)
• Chiba University Hospital — Chiba, Japan (Recruiting)
• Tokyo Medical University Hospital — Tokyo, Japan (Recruiting)
• Tokyo Women's Hospital — Tokyo, Japan (Recruiting)

Study contacts

• Study coordinator: Mieko Otake

Conditions Leadless Pacemaker; leadless pacemaker; AVEIR