Aveir Leadless Dual-Chamber Pacemaker Post-Marketing Surveillance in Japan
Official title: Aveir Leadless Pacemaker Japan Post Marketing Surveillance
Run by Abbott Medical Devices · NCT07106788 · Data updated 2026-11-12
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 |
|---|---|
| Sex | All |
| Enrollment | 304 (estimated) |
| Sponsor | Abbott Medical Devices Industry-sponsored |
| Locations | 14 sites (Nagoya, Aichi-ken and 13 other locations) |
| Status | Recruiting |
| Started | May 26, 2025 |
| Main results expected | November 2029 |
| Study ends | November 2029 |
| Registry record updated | May 13, 2026 |
| Trial ID | NCT07106788 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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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
Show 8 more locations
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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
- Email: mieko.otake@abbott.com
- Phone: +81-80-5866-9006
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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3D Echocardiography to See How CIEDs May Worsen Tricuspid Regurgitation
This study tests whether different CIEDs (leadless pacemakers, LBBaP, and conventional pacemakers) differ in causing worsening tricuspid regurgitation, using 3D heart imaging.
-
Leadless pacemaker outcomes and follow-up at University Hospital St. Pölten
This registry will collect and analyze outcomes and complications in adults who receive leadless pacemakers at University Hospital St. Pölten to see how the devices perform over time.
-
LivIQ leadless pacemaker system for ventricular pacing
This trial will test the LivIQ leadless pacemaker in adults who need ventricular pacing (VVI or VDD) to see if it is safe and maintains appropriate heart rhythm and AV timing.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.