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Should asymptomatic heart valve patients get surgery now? major trial aims to settle debate

NCT ID NCT03389542

Disease control Sponsor: Centre Hospitalier Universitaire, Amiens 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compares two approaches for people with a severe leaky heart valve (mitral regurgitation) who have no symptoms yet. Half will get early valve repair surgery, while the other half will be monitored closely every 6 months. The goal is to see which strategy leads to fewer deaths or serious heart problems over 5 years. About 424 participants are being enrolled.

What this could mean

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

Active substance
mitral valve repair surgery
What this could lead to
If early surgery proves better, it could establish a new standard for treating severe mitral regurgitation before symptoms appear, potentially preventing heart failure and other serious events.
What could go wrong
This is an ongoing trial with results not yet available. Surgery always carries risks like infection or complications, and watchful waiting may be equally safe for some 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.

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

About 424 people

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

Started

Apr 2018

Expected to finish

Apr 2033

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

18 to 75 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 according history or an exercise test in those able to perform it if there is a doubt about the absence of symptoms * Severe (grade IV) degenerative MR due to leaflet prolapse assessed by echocardiography * LV ejection fraction by Simpson biplane method ≥60% and LV end-systolic diameter by TM echocardiography ≤40mm * Sinus rhythm on the inclusion ECG * Pulmonary artery pressure ≤50 mmHg by Doppler echocardiography. * High probability of mitral valve repair * EuroSCORE II ≤ 3% Exclusion Criteria: * Mitral stenosis or \> mild aortic valve disease (stenosis or regurgitation) * Congenital heart disease (except patent foramen ovale or atrial septal defect) * Patients with cardiac prostheses * Previous myocardial infarction * Previous cardiac surgery * Extra cardiac comorbidity with life expectancy \< 5 years * Recent history of psychiatric disease (including drug or alcohol abuse) * Therapy with an investigational intervention at the time of screening or plan to enrol patient in additional intervention study during participation in this trial

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Conditions

The condition(s) this trial relates to.

mitral valve insufficiency mitral valve prolapse

As listed by the trial registrant

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

Degenerative mitral regurgitation (MR) due to leaflet prolapse

How to take part

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

  1. The places running it

    2 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

  • CHU Amiens-Picardie

    RECRUITING

    Amiens, 80054, France

  • Centre Cardiologique du Nord

    RECRUITING

    Saint-Denis, 93200, France