Aveir Leadless Pacemaker Japan PMS

Last updated: May 11, 2026
Sponsor: Abbott Medical Devices
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Aveir DR Leadless Pacemaker Implant

Upgrades

Roll-over

Clinical Study ID

NCT07106788
CL1027565
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient is indicated for dual-chamber or single-chamber atrial leadless pacemakersystem

  • Patient is a roll-over patient with existing Aveir DR leadless pacemaker system fromthe Aveir DR i2i IDE study

  • Patient is an upgrade patient with existing single-chamber Aveir leadless pacemakerthat requires an upgrade to a dual-chamber Aveir leadless pacemaker system

Exclusion

Exclusion Criteria:

  • N/A

Study Design

Total Participants: 304
Treatment Group(s): 4
Primary Treatment: Aveir DR Leadless Pacemaker Implant
Phase:
Study Start date:
May 26, 2025
Estimated Completion Date:
November 30, 2029

Connect with a study center

  • Nagoya University Hospital

    Nagoya, Aichi-ken 466-8550
    Japan

    Active - Recruiting

  • Kokura Memorial Hospital

    Kitakyushu, Fukuoka 802-8555
    Japan

    Active - Recruiting

  • Kokura Memorial Hospital

    Kitakyushu 1859307, Fukuoka 1863958 802-8555
    Japan

    Site Not Available

  • St. Marianna University School of Medicine Hospital

    Kawasaki, Kanagwa 2168511
    Japan

    Active - Recruiting

  • St. Marianna University School of Medicine Hospital

    Kawasaki 1859642, Kanagwa 2168511
    Japan

    Site Not Available

  • Sendai Kousei Hospital

    Sendai, Miyagi 981-0914
    Japan

    Active - Recruiting

  • Sendai Kousei Hospital

    Sendai 2111149, Miyagi 2111888 981-0914
    Japan

    Site Not Available

  • Kurashiki Central Hospital

    Kurashiki, Okayama-ken 710-0052
    Japan

    Active - Recruiting

  • Kurashiki Central Hospital

    Kurashiki 1858311, Okayama-ken 1854381 710-0052
    Japan

    Site Not Available

  • Kansai Medical University Hospital

    Hirakata, Osaka 573-1191
    Japan

    Active - Recruiting

  • Osaka Keisatsu Hospital

    Osaka, Osaka 543-8922
    Japan

    Active - Recruiting

  • National Cerebral & Cardiovascular Center Hospital

    Suita, Osaka 564-8565
    Japan

    Active - Recruiting

  • Osaka Keisatsu Hospital

    Osaka 1853909, Osaka 1853904 543-8922
    Japan

    Site Not Available

  • National Cerebral & Cardiovascular Center Hospital

    Suita 1851483, Osaka 1853904 564-8565
    Japan

    Site Not Available

  • Juntendo University Shizuoka Hospital

    Izunokuni, Shizuok 410-2295
    Japan

    Active - Recruiting

  • Juntendo University Shizuoka Hospital

    Izunokuni 6822191, Shizuok 410-2295
    Japan

    Site Not Available

  • Showa Medical University Hospital

    Shinagawa-ku, Tokyo 142-8666
    Japan

    Active - Recruiting

  • Toho University - Omori Medical Center

    Ōta-ku, Tokyo 143-8541
    Japan

    Active - Recruiting

  • Tokyo Medical University Hospital

    Tokyo 1850147, Tokyo 1850144 160-0023
    Japan

    Site Not Available

  • Tokyo Women's Hospital

    Tokyo 1850147, Tokyo 1850144 162-8666
    Japan

    Active - Recruiting

  • Chiba University Hospital

    Chiba, 260-8677
    Japan

    Active - Recruiting

  • Tokyo Medical University Hospital

    Tokyo, 160-0023
    Japan

    Active - Recruiting

  • Tokyo Women's Hospital

    Tokyo, 162-8666
    Japan

    Active - Recruiting

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