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Heart surgery showdown: which repair works best for kids with leaky valves?

NCT ID NCT07284212

Knowledge-focused Sponsor: China National Center for Cardiovascular Diseases 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 completed study followed 427 children under 14 who had surgery for mitral regurgitation (a leaky heart valve) at eight hospitals in China. Researchers compared two surgical repair strategies to see which led to better outcomes, like survival and avoiding repeat surgery. The goal is to provide real-world evidence to guide surgeons in choosing the best approach for each child.

What this could mean

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

What this could lead to
If successful, this study could help surgeons choose the best repair technique for children with mitral regurgitation, potentially improving long-term heart function and reducing the need for repeat surgeries.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly test a new drug or device. The results may not apply to all children, especially those with other heart conditions.

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

427 people

The number who actually took part.

Started

Mar 2020

Finished

Sep 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Who is studied

Children younger than 14 years with moderate or greater mitral regurgitation undergoing surgical repair at eight representative congenital heart disease centers in China. Eligible patients must not have undergone prior mitral valve surgery and must meet the predefined inclusion and exclusion criteria. The study aims to prospectively evaluate surgical outcomes, durability, and predictors of repair from March 2020 to December 2024, with follow-up completed through September 2025.

Ages

Up to 14 years

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: * Age \< 14 years * No prior mitral valve surgery * Preoperative echocardiography demonstrating moderate or severe mitral regurgitation Exclusion Criteria: * Concomitant cardiac malformations unable to be corrected simultaneously * Moderate or severe mitral stenosis * Ischemic mitral regurgitation * Severe leaflet dysplasia precluding adequate coaptation * Connective tissue disorders(e.g., Barlow's disease, Marfan syndrome) * Any type of cardiomyopathy * Single ventricle physiology or common atrioventricular valve

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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 (MR) Pediatric cardiac surgery

Contacts and locations

Locations

  • Pediatric Cardiac Surgery Center, Fuwai Hospital

    Beijing, Beijing Municipality, 100037, China

More trials for these conditions

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