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

NCT ID NCT03271762

Ongoing Disease control Sponsor: Nantes University Hospital Source: ClinicalTrials.gov ↗

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.

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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

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

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