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Should symptom-free patients get early heart valve repair? new trial investigates.

NCT ID NCT01406353

Disease control Sponsor: Asan Medical Center 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether doing a heart valve repair procedure early, before symptoms appear, is better than waiting and using standard care for people with moderate mitral stenosis. The trial includes 167 participants who have no symptoms but are at risk for future heart problems like stroke or irregular heartbeat. The goal is to see if early intervention reduces the chance of serious heart events.

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

167 people

The number who actually took part.

Started

Jul 2011

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

20 to 70 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: * asymptomatic patients with moderate MS who are potential candidates for early percutaneous mitral commissurotomy Exclusion Criteria: * patients with exertional dyspnea * total echocardiographic score \> 10 * moderate to severe mitral regurgitation * left atrial thrombi * significant aortic valve disease, * left ventricle (LV) ejection fraction (EF) \<50% * Doppler-estimated pulmonary artery systolic pressure \>50 mmHg * those who were not candidates for early intervention based on age \> 70 years or the presence of coexisting malignancies

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Conditions

The condition(s) this trial relates to.

mitral valve stenosis

As listed by the trial registrant

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

Moderate mitral stenosis

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, 138-736, South Korea

  • Samsung Medical Center

    Seoul, South Korea

  • Yonsei University Severance Hospital

    Seoul, South Korea