Aveir Leadless Pacemaker Japan PMS

Recruiting now

Conditions studied: Leadless Pacemaker

In brief

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.

Key facts

Study ID

NCT07106788

Run by

Abbott Medical Devices

People needed

304

Starts

2025-05-26

Expected to finish

2029-11-01

Last updated by the study team

2026-05-13

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• N/A

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.