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New clip device aims to fix leaky heart valve without open surgery

NCT ID NCT07509658

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study is checking how well the TriClip device works and how safe it is for people in Japan with a leaky tricuspid valve. The device is already approved for use, and this study will follow 250 patients to confirm its benefits in everyday medical practice. The main goal is to see if the valve leakage is reduced to moderate or less within 30 days.

What this could mean

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

Active substance
TriClip System (a device that clips the tricuspid valve to reduce leakage)
What this could lead to
If successful, this study could confirm that the TriClip device works safely in Japanese patients, offering a less invasive treatment option for tricuspid regurgitation.
What could go wrong
This is an observational study, not a randomized trial, so results may be less definitive. The device is already approved, but long-term benefits and risks in this population are still being confirmed.

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 250 people

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

Started

Mar 2026

Expected to finish

Dec 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

This observational post-approval study will enroll subjects from the general Japanese population who are scheduled to undergo the TriClip procedure per the current Japan IFU.

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: * Subjects are eligible to receive the TriClip System per the current approved indications for use (IFU) * Subjects provide written informed consent prior to conducting any investigation-specific procedures not considered standard of care. Exclusion Criteria: * There are no exclusion criteria * Please note: It is not recommended that subjects enrolled in the study participate in any other therapeutic clinical study.

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Conditions

The condition(s) this trial relates to.

tricuspid valve insufficiency

As listed by the trial registrant

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

Tricuspid regurgitation

How to take part

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

  1. The places running it

    1 site. 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

  • National Cerebral & Cardiovascular Center Hospital

    RECRUITING

    Suita, Osaka, 564-8565, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.