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Heart valve clip could cut hospital visits for heart failure patients

NCT ID NCT01920698

Disease control Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a device called MitraClip, which is a small clip placed through a tube in a vein to repair a leaky mitral valve in the heart. The trial included 304 people with severe mitral regurgitation and heart failure. Half got the clip plus standard medical care, and half got standard care alone. Researchers tracked deaths and unplanned hospital stays for heart failure over two years to see if the clip helped.

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 clip implanted via catheter to repair the mitral valve)
What this could lead to
If successful, this could provide a less invasive treatment option for people with severe mitral regurgitation, potentially reducing deaths and hospital stays.
What could go wrong
This is a completed trial, but results may not apply to all patients. The procedure carries risks like bleeding, infection, or valve damage, and may not work for everyone.

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

304 people

The number who actually took part.

Started

Nov 2013

Finished

Mar 2019

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 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: * Age \> 18 years old * Severe secondary mitral regurgitation characterised, according to the European guidelines and recommendations, by a regurgitant volume\>30 mL/beat or an effective regurgitant orifice\>20 mm². * New York heart Association Class≥ II. * Left ventricular ejection fraction between 15% and 40% * Minimum of 1 hospitalization for heart failure within 12 months preceding randomization * Optimal standard of care therapy for heart failure according to investigator. * Not eligible for a mitral surgery intervention according to the Heart Team. * Willingness to participate in the study and signed written informed consent * Affiliation to a health insurance system or a similar system Exclusion Criteria: * Eligible for a mitral surgery intervention according to the Heart Team. * Primary mitral regurgitation. * Myocardial infarction or coronary bypass grafting surgery within three months prior to randomization. * Cardiac resynchronization therapy within three months prior to randomization. * Cardioversion within three months prior to randomization * Transcatheter aortic valve implantation within three months prior to randomization * Need for any cardiovascular surgery (including registration on cardiac transplant list). * Coronary angioplasty within one month prior to randomization. * Previous surgical mitral valve repair. * Renal replacement therapy. * Active infection requiring current antibiotic therapy. * Severe hepatic insufficiency. * Stroke within three months prior to randomization. * Concurrent medical condition with a life expectancy of less than 12 months. * Uncontrolled arterial hypertension. * Hypersensitivity to nitinol. * Participation to another trial. * Pregnancy. * No affiliation to a health insurance system. * Legal protection measure (guardianship or curatorship)

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder heart disorder heart failure heart valve disorder mitral valve insufficiency

As listed by the trial registrant

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

Cardiovascular diseases

Contacts and locations

Locations

  • APHP Hôpital Henri Mondor

    Créteil, France

  • Aphp Hopital Bichat

    Paris, France

  • CH Annecy Genevois

    Metz-Tessy, 74370, France

  • CHRU La Cavale Blanche

    Brest, France

  • CHRU La Milétrie

    Poitiers, France

  • CHRU de Tours

    Tours, France

  • CHU Caen

    Caen, 14000, France

  • CHU Rouen

    Rouen, France

  • CHU d'Angers

    Angers, 49933, France

  • CHU de Grenoble

    Grenoble, 38700, France

  • Centre Cardiologique du Nord

    Saint-Denis, France

  • Centre Chirurgical Marie Lannelongue

    Le Plessis-Robinson, France

  • Centre chirurgicale Ambroise Paré

    Neuilly-sur-Seine, 92200, France

  • Chu de Besancon

    Besançon, France

  • Chu de Bordeaux

    Bordeaux, France

  • Chu de Lille

    Lille, France

  • Chu de Montpellier

    Montpellier, France

  • Chu de Nancy

    Nancy, France

  • Chu de Nantes

    Nantes, France

  • Chu de Rennes

    Rennes, France

  • Chu de Strasbourg

    Strasbourg, France

  • Chu de Toulouse

    Toulouse, France

  • Clinique Cardiologique Saint Gatien

    Tours, France

  • Clinique Du Millenaire

    Montpellier, France

  • Clinique Pasteur

    Toulouse, 31076, France

  • Clinique du Tonkin

    Villeurbanne, France

  • Groupe Hospitalier La Salpétrière

    Paris, 75013, France

  • Groupement Hospitalier Est

    Bron, France

  • Hopital de La Timone

    Marseille, France

  • Hôpital Européen Georges Pompidou

    Paris, 75015, France

  • Hôpital Gabriel Montpied

    Clermont-Ferrand, 63000, France

  • Hôpital Nord

    Saint-Etienne, 42055, France

  • Hôpital Pasteur

    Nice, 06001, France

  • Hôpital Saint-Joseph

    Marseille, 13285, France

  • Hôpital privé Clairval

    Marseille, France

  • Hôpital privé de Parly 2

    Le Chesnay, 78150, France

  • Hôpital privé le Bois

    Lille, France

  • Institut Arnault Tzanck

    Saint-Laurent-du-Var, France

  • Institut Hospitalier Jacques Cartier

    Massy, France

  • Institut Mutualiste Montsouris

    Paris, 75014, France

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