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Tiny pacemaker without wires under safety watch in japan

NCT ID NCT07106788

Disease control Sponsor: Abbott Medical Devices Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is tracking the safety of the Aveir leadless pacemaker in 304 Japanese patients who need a pacemaker. The device is placed directly inside the heart without wires. Researchers will monitor for serious complications over three years. The goal is to confirm the device is safe for routine use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Aveir leadless pacemaker (device)
What this could lead to
If successful, this could confirm that the Aveir leadless pacemaker is safe and effective for long-term use in Japanese patients, supporting its wider adoption.
What could go wrong
This is an observational post-market study, not a randomized trial. It only tracks complications, not whether the device works better than alternatives. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 304 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The Surveillance will register patients who are indicated for dual-chamber leadless pacemaker, single-chamber atrial leadless pacemaker, roll-over patients with existing Aveir DR leadless pacemaker system from the Aveir DR i2i IDE study, and upgrade patients with existing single-chamber Aveir leadless pacemaker that require an upgrade to a dual-chamber Aveir leadless pacemaker system.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Leadless pacemaker

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Chiba University Hospital

    RECRUITING

    Chiba, 260-8677, Japan

  • Juntendo University Shizuoka Hospital

    RECRUITING

    Izunokuni, Shizuok, 410-2295, Japan

  • Kansai Medical University Hospital

    RECRUITING

    Hirakata, Osaka, 573-1191, Japan

  • Kokura Memorial Hospital

    RECRUITING

    Kitakyushu, Fukuoka, 802-8555, Japan

  • Kurashiki Central Hospital

    RECRUITING

    Kurashiki, Okayama-ken, 710-0052, Japan

  • Nagoya University Hospital

    RECRUITING

    Nagoya, Aichi-ken, 466-8550, Japan

  • National Cerebral & Cardiovascular Center Hospital

    RECRUITING

    Suita, Osaka, 564-8565, Japan

  • Osaka Keisatsu Hospital

    RECRUITING

    Osaka, Osaka, 543-8922, Japan

  • Sendai Kousei Hospital

    RECRUITING

    Sendai, Miyagi, 981-0914, Japan

  • Showa Medical University Hospital

    RECRUITING

    Shinagawa-ku, Tokyo, 142-8666, Japan

  • St. Marianna University School of Medicine Hospital

    RECRUITING

    Kawasaki, Kanagwa, 2168511, Japan

  • Toho University - Omori Medical Center

    RECRUITING

    Ōta-ku, Tokyo, 143-8541, Japan

  • Tokyo Medical University Hospital

    RECRUITING

    Tokyo, 160-0023, Japan

  • Tokyo Women's Hospital

    RECRUITING

    Tokyo, 162-8666, Japan

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