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New clip fixes leaky heart valve without open surgery

NCT ID NCT04259411

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested the MitraClip device in 51 people in China with a leaky heart valve (mitral regurgitation). The device is inserted through a vein in the leg and clips the valve to reduce leakage. The goal was to see if the procedure is safe and effective, with recovery typically taking two to three days.

What this could mean

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

Active substance
MitraClip device (a catheter-based clip to repair the mitral valve)
What this could lead to
If successful, this could offer a less invasive treatment option for people with mitral regurgitation, reducing symptoms and improving daily life without open-heart surgery.
What could go wrong
This was a small, single-arm study with no comparison group, so results may not apply broadly. Risks include procedural complications like stroke or heart attack.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

51 people

The number who actually took part.

Started

Dec 2021

Finished

Mar 2025

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.

Ages

18 years and older

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: 1. Subjects is eligible to receive the MitraClip per the current approved MitraClip System IFU. (If any update or amendment on the IFU, the latest version of IFU shall be followed.) 2. Subject is 18 years-old or above. 3. Subjects who give consent for study procedure. Exclusion Criteria: 1. Subject cannot tolerate procedural anticoagulation or anti-platelet regimen. 2. Subject with active endocarditis of mitral valve. 3. Subject with rheumatic mitral valve disease. 4. Subject with echocardiographic evidence of intracardiac, IVC or femoral venous thrombus. 5. Subject is unlikely to survive the protocol follow up period of 12-months after device implant. 6. Subject has insufficient or lost ability to maintain their will and rights. 7. Subject is illiterate. 8. Pregnant or nursing subjects and those who plan pregnancy during the study follow-up period 9. Subject participates in another clinical study that may impact the follow-up or results of this study.

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Conditions

The condition(s) this trial relates to.

mitral valve insufficiency

As listed by the trial registrant

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

Mitral regurgitation

Contacts and locations

Locations

  • Fuwai Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, China

  • Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen

    Shenzhen, Guangdong, China

  • The 2nd Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang, 310009, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, China

  • Xiamen Cardiovascular Hospital Xiamen University

    Xiamen, Fujian, 361008, China

More trials for these conditions

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