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New valve replacement offers hope for heart leak patients who can't have standard surgery

NCT ID NCT05496998

Disease control Sponsor: Medtronic Cardiovascular 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Updated 2 times

Summary

This study tests a new device (Intrepid TMVR) to replace the mitral valve in people with severe mitral regurgitation (leaky heart valve) who are not candidates for standard surgery or repair. About 400 participants will receive the device and be followed for safety and effectiveness. The goal is to see if the device can stop or greatly reduce the backward blood flow and improve survival.

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 400 people

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

Started

Feb 2023

Expected to finish

Dec 2038

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Subject has moderate-to-severe or severe symptomatic mitral regurgitation as defined by the American Society of Echocardiography 2017 Guidelines and Standards - Recommendations for Non-invasive Evaluation of Native Valvular Regurgitation, or subject has moderate symptomatic mitral regurgitation combined with mitral stenosis with the presence of MAC * Local site multidisciplinary heart team experienced in mitral valve therapies agrees that patient is unsuitable for treatment with approved transcatheter repair or conventional mitral valve surgery * Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits * Subject meets the legal minimum age to provide informed consent based on local regulatory requirements * Subjects anatomically suitable for the Medtronic Intrepid™ TMVR TF System Exclusion Criteria: * Estimated life expectancy of less than 24 months * Currently surgically implanted mitral valve * Prior transcatheter mitral valve procedure with device currently implanted * Anatomic contraindications * Anatomically prohibitive mitral annular calcification (MAC) * Aortic valve disease requiring intervention or previous intervention within 90 days of enrollment * LVEF \< 25% (measured by resting transthoracic echocardiogram), patients with LVEF 25 - \<30% will be further evaluated by the Screening Committee for approval (Right Ventricular Dysfunction, pulmonary hypertension, and left ventricular function) * Left ventricular end diastolic diameter (LVEDD) \> 75mm * Need for emergent or urgent surgery * Hemodynamic instability * History of bleeding diathesis or coagulopathy * End stage renal disease * Liver failure * Frailty

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Conditions

The condition(s) this trial relates to.

follicular lymphoma gastroesophageal reflux disease mitral valve insufficiency mitral valve stenosis

As listed by the trial registrant

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

Mitral regurgitation

How to take part

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

  1. The places running it

    37 sites in 8 countries. 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

  • Aarhus University Hospital

    RECRUITING

    Aarhus, 8200, Denmark

  • Azienda Ospedaliera Spedali Civili di Brescia

    RECRUITING

    Brescia, 25123, Italy

  • Azienda Ospedaliero - Universitaria di Bologna - Policlinico S.Orsola Malpighi

    RECRUITING

    Bologna, 40138, Italy

  • Azienda Ospedaliero Universitaria Pisana

    RECRUITING

    Pisa, 56124, Italy

  • CHRU de Tours

    RECRUITING

    Tours, 37044, France

  • CHU Bordeaux

    RECRUITING

    Bordeaux, Pessac Cedex, 33600, France

  • CHU Rennes - Pontchaillou Hospital

    RECRUITING

    Rennes, 35033, France

  • CHU Timone

    RECRUITING

    Marseille, 13385, France

  • CHU de Nantes

    RECRUITING

    Nantes, 44093, France

  • Catharina Hospital

    RECRUITING

    Eindhoven, 5623 EJ, Netherlands

  • Central University Hospital of Asturias

    RECRUITING

    Oviedo, 33011, Spain

  • Centre Cardiologique du Nord (CCN)

    RECRUITING

    Saint-Denis, 93200, France

  • Clinique Pasteur

    RECRUITING

    Toulouse, Cedex 03, 31076, France

  • Deutsches Herzzentrum München

    RECRUITING

    München, 80636, Germany

  • Deutsches Herzzentrum der Charité (DHZC)

    RECRUITING

    Berlin, 13353, Germany

  • Erasmus University Medical Center

    RECRUITING

    Rotterdam, 3015 AA, Netherlands

  • Guys & St Thomas NHS Foundation Trust - St Thomas Hospital London

    RECRUITING

    London, SE1 7EH, United Kingdom

  • Heart and Diabetes Center NRW

    RECRUITING

    Bad Oeynhausen, 32545, Germany

  • Henri-Mondor University Hospital

    RECRUITING

    Créteil, 94000, France

  • Herzzentrum Leipzig

    RECRUITING

    Leipzig, 04289, Germany

  • Hospital Clínic de Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital Universitario Ramón y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • IRCCS Policlinico San Donato

    RECRUITING

    San Donato Milanese, 20097, Italy

  • LMU Clinic of University Hospital München

    RECRUITING

    München, 81377, Germany

  • Leeds General Infirmary

    RECRUITING

    Leeds, LS1 3EX, United Kingdom

  • Odense University Hospital

    RECRUITING

    Odense, 5000, Denmark

  • Ospedale San Raffaele

    RECRUITING

    Milan, 20132, Italy

  • Rigshospitalet

    RECRUITING

    Copenhagen, 2100, Denmark

  • Royal Brompton Hospital

    RECRUITING

    London, SW3 6NP, United Kingdom

  • St. Antonius Hospital

    RECRUITING

    Nieuwegein, 3435 CM, Netherlands

  • University Hospital Alvaro Cunqueiro

    RECRUITING

    Vigo, 36312, Spain

  • University Hospitals Sussex NHS Foundation Trust

    RECRUITING

    Brighton, BN2 5BE, United Kingdom

  • University Medical Center Mainz

    RECRUITING

    Mainz, 55131, Germany

  • Universitäres Herz- und Gefäßzentrum Hamburg

    RECRUITING

    Hamburg, 20246, Germany

  • Universitätsklinikum Bonn

    RECRUITING

    Bonn, 53127, Germany

  • Universitätsklinikum Ulm

    RECRUITING

    Ulm, 89081, Germany

  • Universitätsspital Bern

    RECRUITING

    Bern, 3010, Switzerland

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