Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New clip device could spare High-Risk heart patients from open surgery

NCT ID NCT03271762

Disease control Sponsor: Nantes University Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a device called MitraClip, which repairs the mitral valve through a small tube inserted in a blood vessel, works as well as traditional open-heart surgery for people with severe mitral regurgitation who are at high risk for surgery. About 330 participants will be randomly assigned to get either the MitraClip or surgery and followed for two years. The main goal is to see if the clip is non-inferior in preventing death, heart failure hospitalizations, and repeat valve procedures.

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 (percutaneous mitral valve repair)
What this could lead to
If successful, this could offer a less invasive alternative to open-heart surgery for people with severe mitral regurgitation who are too frail for surgery.
What could go wrong
This is a non-inferiority trial, meaning it aims to show MitraClip is not worse than surgery, not that it is better. The device may still have risks like bleeding or valve complications, and long-term durability is unknown.

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 330 people

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

Started

Mar 2018

Expected to finish

Jan 2028

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 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: Primary Mitral Regurgitation grade 3+ or 4+ * Patients in class II to IV NYHA * Mitral valve anatomy appropriate to MitraClip® therapy and mitral valve surgery * Adult patients judged eligible for mitral valve surgery by the local heart team but at high surgical risk defined as: age ≥ 75 years and STS score ≥ 6 % or one frailty index or one major organ system compromise or one possible procedure-specific impediment (using MVARC definitions) ; or age \< 75 years and STS score \> 8 % or at least one other high-risk criterion following the MVARC definitions; or age \> 80 years and judged at high risk for surgery by the local heart team * Isolated Mitral valve pathology * If revascularization procedures are required, they must be performed more than 30 days from intervention (D0) * Patients affiliate to social security Non-inclusion Criteria: * Life expectancy \< 1 year due to non-cardiac conditions * Secondary Mitral regurgitation * Evolving endocarditis or active endocarditis or inflammatory disease in the last 3 months * Patient who cannot tolerate procedural anticoagulation or post procedural antiplatelet regimen * Rheumatic mitral valve disease * Evidence of intracardiac, inferior vena cava or femoral venous thrombus * Valve anatomy not compatible with MitraClip® implantation (cf. colum 3 table 3 page 57) * Stroke or transient ischaemic event within 30 days before D0 * Modified Rankin Scale ≥4 disability (appendix 9) * TAVR within 30 days before D0-Untreated, clinically significant coronary artery disease requiring revascularization * Any percutaneous cardiovascular intervention within 30 days before D0 including ATC * Cardiovascular surgery, or carotid surgery within 30 days before D0 * Any prior mitral valve surgery or transcatheter mitral valve procedure * Need for any concomitant cardiac surgery including treatment of severe secondary tricuspid regurgitation in accordance with class I recommendation in 2017 ESC guidelines. Surgical treatment of mild or moderate secondary tricuspid regurgitation (Class IIa and IIb recommendations) can still be performed in the protocol according to the local heart team decison * NYHA functional class I * LVEF \< 30% * Primary MR grade 1 to 2 * Subjects in whom transesophageal echocardiography or transseptal catheterization are contraindicated or high-risk * Any condition preventing the patient from completing all protocol procedures (including compliance with guidelines directed medical therapy) and follow-up visits * Patient unable or unwilling to provide written, informed consent before study enrolment * Pregnant or nursing women * Vulnerable people: persons deprived of liberty; under trusteeship or under curatorship * Participation in another trial that would interfere with this trial Exclusion criteria * Not eligible for a MitraClip® intervention after Core Lab evaluation * Before randomization (D-21) the patient no longer fulfills eligibility criteria (inclusion criteria and non-inclusion criteria)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Mitral regurgitation are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • CHU Félix Guyon

    Saint-Denis, 97400, France

  • CHU LYON

    Lyon, France

  • CHU de Rouen

    Rouen, France

  • Centre Cardiologique Du Nord

    Saint-Denis, France

  • Centre Chirurgical Marie Lannelongue

    Le Plessis-Robinson, France

  • Ch Annecy

    Annecy, 74370, France

  • Chru Brest

    Brest, France

  • Chru Lille

    Lille, 59000, France

  • Chru Tours

    Tours, France

  • Chu Angers

    Angers, France

  • Chu Bordeaux

    Bordeaux, France

  • Chu Grenoble

    Grenoble, France

  • Chu Nantes

    Nantes, France

  • Chu Poitiers

    Poitiers, France

  • Chu Rennes

    Rennes, France

  • Chu Saint Etienne

    Saint-Etienne, 42277, France

  • Clinique Du Millenaire

    Montpellier, 34000, France

  • Clinique Du Tonkin

    Villeurbanne, 69100, France

  • Clinique Pasteur

    Toulouse, France

  • Clinique de La Sauvegarde

    Lyon, 69009, France

  • Hopital Bichat

    Paris, France

  • Hopital Civil Strasbourg

    Strasbourg, France

  • Hopital Europeen Georges Pompidou

    Paris, France

  • Hopital Henri Mondor Aphp

    Créteil, France

  • Hopital La Pitie Salpetriere

    Paris, France

  • Hopital La Timone

    Marseille, France

  • Hopital Prive Le Bois Lille

    Lille, 59000, France

  • Hopital Rangueil

    Toulouse, France

  • Hopital St Joseph

    Marseille, France

  • Institut Hospitalier Jacques Cartier

    Massy, France

  • Institut Mutualiste Montsouris

    Paris, France

More trials for these conditions

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