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New heart valve fix without cutting chest shows promise for High-Risk patients

NCT ID NCT04029363

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study is testing a new device called the HighLife 28mm mitral valve, which is placed through a tube in a vein to replace a leaky heart valve without open-heart surgery. It is for 120 people with moderate-severe or severe mitral regurgitation who are at high risk for surgery. The goal is to see if the device is safe and works well.

What this could mean

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

Active substance
HighLife Transcatheter Mitral Valve Replacement device
What this could lead to
If successful, this could offer a less invasive treatment option for people with severe mitral regurgitation who are too high-risk for open-heart surgery.
What could go wrong
This is an early study with only 120 participants, so results may not apply to everyone. The procedure carries risks like bleeding, infection, or device complications.

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 120 people

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

Started

May 2019

Expected to finish

Dec 2031

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: * 1\. Age ≥ 18 years 2. Moderate-severe or severe mitral regurgitation (≥ 3+) 3. Patient has New York Heart Association (NYHA) Functional Class II, III or ambulatory IV 4. Patient is under guideline directed medical therapy, as reviewed and confirmed by the local multidisciplinary Heart Team, for at least one month 5. Patient is high-risk for open-heart surgery based on the assessment of the multidisciplinary Heart Team using standard scoring systems and consideration of co-morbidities, frailty, and disability 6. Patient meets the anatomical criteria for HighLife valve 7. Patient is willing to participate in the study and provides signed informed consent Exclusion Criteria: 1. Any stroke/TIA within 30 days 2. Severe symptomatic carotid stenosis (\> 70% by non-invasive imaging) 3. Active infections requiring antibiotic therapy 4. Active ulcer or gastro-intestinal bleeding in the past 3 months 5. History of bleeding diathesis, coagulopathy or refusal of future blood transfusion 6. Patients in whom TEE is not feasible 7. Patients who are pregnant or lactating, or plan to get pregnant in the next 12 months. 8. Patient is unable to comply with the follow-up schedule and assessments 9. Participation in another clinical investigation at the time of inclusion 10. Patient has known allergies to the device components or contrast medium 11. Patient cannot tolerate anticoagulation or antiplatelet therapy 12. Patients with a life expectancy of less than 12 months due to non-cardiac conditions 13. Patient had permanent pacemaker, or similar device with implantable cardiac leads (i.e. resynchronization therapy) within the last 3 months \-

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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

How to take part

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

  1. The places running it

    39 sites in 7 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

  • AZ Sint-Jan

    RECRUITING

    Bruges, 8000, Belgium

  • Barts Heart Center

    TERMINATED

    London, United Kingdom

  • Brighton and Sussex University Hospital

    RECRUITING

    Brighton, BN2 5BE, United Kingdom

  • CHRU Strasbourg

    RECRUITING

    Strasbourg, France

  • CHU Bordeaux

    RECRUITING

    Pessac, 33600, France

  • CHU Lille

    RECRUITING

    Lille, France

  • CHU de Rennes

    RECRUITING

    Rennes, 35000, France

  • Centr Cardiologiqque du Nord

    RECRUITING

    Saint-Denis, France

  • Centre Hospitalo-Universitaire de Nantes

    RECRUITING

    Nantes, France

  • Clinque Pasteur

    RECRUITING

    Toulouse, 31076, France

  • Deutsches Herzzentrum Munchen

    RECRUITING

    Munich, Germany

  • European Hospital George Pompidou

    TERMINATED

    Paris, 5015, France

  • Guy's and St. Thomas' NHS Foundation Trust - St. Thomas Hospital

    RECRUITING

    London, SE1 9RS, United Kingdom

  • Heart Center, University Hospital Dresden

    RECRUITING

    Dresden, Germany

  • Herzentrum Leipzig

    RECRUITING

    Leipzig, 04289, Germany

  • Hopital Prive - Jacques Cartier

    RECRUITING

    Massy, France

  • Institute of Cardiology

    RECRUITING

    Warsaw, 04-628, Poland

  • John Hunter Hospital

    RECRUITING

    Newcastle, New South Wales, 2305, Australia

  • John Hunter Hospital

    RECRUITING

    Newcastle, Australia

  • John Radcliffe

    TERMINATED

    Oxford, United Kingdom

  • Leeds Teaching Hospitals NHS Trust

    TERMINATED

    Leeds, United Kingdom

  • Macquarie University Hospital

    WITHDRAWN

    Sydney, New South Wales, 2109, Australia

  • Medical University of Gdansk

    RECRUITING

    Gdansk, Poland

  • Medical University of Silesia Hospital

    RECRUITING

    Katowice, 40-635, Poland

  • Medical University of Warsaw

    RECRUITING

    Warsaw, 02-097, Poland

  • Mediinisches Versorgungszentrum

    RECRUITING

    Hamburg, Germany

  • Medipole Lyon-Villeurbanne

    RECRUITING

    Lyon, France

  • Mount Hospital

    RECRUITING

    Perth, 6150, Australia

  • National Heart Center Singapore

    RECRUITING

    Singapore, Singapore

  • North Shore Private Hospital

    RECRUITING

    Sydney, Australia

  • Princess Alexandra Hospital

    RECRUITING

    Brisbane, Australia

  • Rangueil University Hospital

    RECRUITING

    Toulouse, Toulouse, 31400, France

  • Rangueil University Hospital

    RECRUITING

    Toulouse, France

  • Royal Infirmary of Edinburgh

    RECRUITING

    Edinburgh, United Kingdom

  • Royal Victoria Hospital

    RECRUITING

    Belfast, United Kingdom

  • St. Andrew's Hospital

    RECRUITING

    Adelaide, 5000, Australia

  • St. Vincent's Hospital - Sydney

    RECRUITING

    Darlinghurst, New South Wales, 2010, Australia

  • The Alfred Hospital

    RECRUITING

    Melbourne, 3004, Australia

  • The Wesley Hospital

    RECRUITING

    Auchenflower, Queensland, 4066, Australia

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • Universitaetsklinikum Bonn

    RECRUITING

    Bonn, 53127, Germany

  • Universitatsklink Hamburg-Eppendorf

    RECRUITING

    Hamburg, 20246, Germany

  • University Heart Center Freiburg - Bad Krozingen

    TERMINATED

    Bad Krozingen, 79189, Germany

  • University Hospital Heidelberg

    TERMINATED

    Heidelberg, Germany

  • University Hospital Ulm

    RECRUITING

    Ulm, 89081, Germany

  • University Hospital of Lord's Transfiguration

    TERMINATED

    Poznan, 61-848, Poland

  • University Hospitals of Leicester NHS Trust

    TERMINATED

    Leicester, United Kingdom

  • University Medicine Dept of Cardiology

    TERMINATED

    Rostock, Germany

  • Warringal Hospital

    TERMINATED

    Heidelberg, 3084, Australia

  • ZNA Middelheim

    RECRUITING

    Antwerp, 2020, Belgium

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