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New study: can a simple clip replace Open-Heart surgery for seniors with leaky heart valves?

NCT ID NCT05051033

Disease control Sponsor: Annetine Gelijns 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This study compares two ways to fix a leaky mitral valve in people aged 60 and older: a less invasive procedure using a clip (TEER) versus traditional open-heart surgery. About 450 participants will be randomly assigned to one of the two treatments. The goal is to see if the clip works as well as surgery at preventing death, repeat procedures, or worsening of the leak over at least three years.

What this could mean

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

Active substance
Mitral valve repair (surgery or transcatheter clip)
What this could lead to
If TEER proves as effective as surgery, older patients could avoid open-heart surgery and recover faster while still controlling their heart valve disease.
What could go wrong
This is a mid-stage trial with 450 participants, so results may not apply to everyone. TEER might not fix the leak as well as surgery, and both procedures carry risks like infection or bleeding.

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

450 people

The number who actually took part.

Started

Feb 2022

Expected to finish

Jan 2034

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

60 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.

The patient population for this trial consists of adults with severe, primary degenerative MR for whom the local heart team has verified that an indication for MV intervention is present and for whom both transcatheter edge-to-edge and surgical repair strategies are anatomically feasible. Specific inclusion and exclusion criteria are listed below. All patients who meet eligibility criteria will be included in the study regardless of gender, race, or ethnicity. Inclusion Criteria: * Adult patients ≥60 years with moderately-severe or severe (3+ or 4+/4+) primary degenerative (Carpentier type II) MR defined by transthoracic echocardiography * Clinical indication for MV intervention and anatomic candidate for both surgical MV repair and transcatheter edge-to-edge repair (TEER) per local heart team assessment with central eligibility committee verification * Patients across the surgical risk spectrum (low, intermediate, and high risk) depending on local heart team assessment and central eligibility committee verification (see ACC/AHA 2020 guidelines for the management of patients with valvular heart disease) * Patients with AF who meet an indication for a concomitant ablation procedure be included provided the local heart team and central eligibility committee decide they are eligible for both catheter-based and surgical ablation. * Ability to perform 6-minute walk test (6MWT) and complete Kansas City Cardiomyopathy Questionnaire (KCCQ) instrument Exclusion Criteria: * Non-degenerative types of primary MR (e.g., cleft leaflet) * Secondary or functional MR * Hypertrophic obstructive cardiomyopathy * Presence of an IVC filter or permanent pacing/ICD leads that would interfere with TEER per local heart team assessment * Known allergic reactions to intravenous contrast * Febrile illness within 30-days prior to randomization * Any absolute contraindication to transesophageal echocardiography * Any contraindication to systemic heparinization including active bleeding diatheses, and heparin induced thrombocytopenia * Patients with CAD requiring revascularization * Any prior mitral valve intervention or any prior repair of atrial septal defect * Any prior MV intervention or any prior repair of atrial septal defect * Need for any of the following concomitant procedures: aortic valve or aortic surgery, tricuspid valve surgery * Need for any emergency intervention or surgery * Active endocarditis * Hemodynamic instability defined as cardiac index \<2.0 l/min/m2 or systolic blood pressure \<90mmHg or need for inotropic support or any mechanical circulatory support * Left ventricular ejection fraction \<25% * Intracardiac mass or thrombus * Co-morbid medical or oncologic condition for which local heart team believes that survival beyond 2 years is unlikely * Active substance abuse * Suspected inability to adhere to follow-up * Treatment with another investigational drug or other intervention, assessment of which has not completed the primary endpoint or that clinically interferes with the present study endpoints.

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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 valve regurgitation

Contacts and locations

Locations

  • Asklepios Klinik St. Georg Hamburg

    Hamburg, 20099, Germany

  • Barts Health NHS Trust

    London, E1 8PR, United Kingdom

  • Baylor, Scott and White

    Dallas, Texas, 75246, United States

  • Brigham and Women's

    Boston, Massachusetts, 02115, United States

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • Deutsches Herzzentrum München

    München, 80636, Germany

  • Deutsches Herzzentrum der Charité

    Berlin, 13353, Germany

  • Duke University Hospital

    Durham, North Carolina, 27710, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Golden Jubilee University National Hospital

    Clydebank, G81 4DY, United Kingdom

  • Herz- und Diabeteszentrum NRW

    Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

  • Herzzentrum Leipzig

    Leipzig, 04289, Germany

  • Hospital Alvaro Cunqueiro

    Vigo, Galacia, 36204, Spain

  • Hospital Central de Asturias

    Oviedo, 33011, Spain

  • Hospital Clinic De Barcelona

    Barcelona, 08036, Spain

  • Hospital Clínico San Carlos

    Madrid, 28040, Spain

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (Laval University)

    Québec, Quebec, QC G1V 4G5, Canada

  • Keck Hospital of the University of Southern California

    Los Angeles, California, 90033, United States

  • Kerckhoff Klinik Bad Nauheim

    Bad Nauheim, 61231, Germany

  • King's College Hospital NHS Foundation Trust

    London, England, SE5 9RS, United Kingdom

  • London Health Sciences

    London, Ontario, ON N6A 5W9, Canada

  • Maine Medical Center

    Portland, Maine, 04102, United States

  • Manchester University NHS Foundation Trust

    Manchester, England, M23 9LT, United Kingdom

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • New York-Presbyterian/Columbia University Medical Center

    New York, New York, 10032, United States

  • Northwell Health

    New York, New York, 21287, United States

  • Ochsner Clinic

    New Orleans, Louisiana, 70121, United States

  • Oxford University Hospitals NHS Foundation Trust

    Headington, OX3 9DU, United Kingdom

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309, United States

  • Royal Brompton and Harefield Guy's and St Thomas' NHS Foundation Trust

    London, England, SW3 6NP, United Kingdom

  • Royal Papworth Hospital NHS Foundation Trust

    Cambridge, England, CB2 0AY, United Kingdom

  • Saint Luke's Hospital of Kansas City/MidAmerica Heart and Lung Surgeons

    Kansas City, Missouri, 64111, United States

  • Schüchtermann-Klinik Bad Rothenfelde

    Bad Rothenfelde, 49214, Germany

  • South Tees Hospital NHS Foundation Trust

    Middlesbrough, United Kingdom

  • South Tees Hospitals NHS Foundation Trust

    Middlesbrough, TS4 3BW, United Kingdom

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

    London, England, SE1 7EH, United Kingdom

  • Stanford University

    Stanford, California, 94305, United States

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • The Leeds Teaching Hospitals NHS Trust

    Leeds, England, LS1 3EX, United Kingdom

  • Unity Health Toronto (St. Michael's Hospital)

    Toronto, Ontario, M5B 1W8St, Canada

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2TH, United Kingdom

  • University Hospitals Sussex NHS Foundation Trust

    Worthing, West Sussex, BN2 5BE, United Kingdom

  • University of British Columbia, Providence Health Care, St. Paul's Hospital

    Vancouver, British Columbia, BC V6E 1M7, Canada

  • University of California San Francisco

    San Francisco, California, 94143, United States

  • University of Michigan Hospital

    Ann Arbor, Michigan, 48109, United States

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7, Canada

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22903, United States

  • Universitätsklinikum Frankfurt

    Frankfurt, 60590, Germany

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106, Germany

  • Universitätsklinikum Hamburg Eppendorf

    Hamburg, 20246, Germany

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • Universitätsklinikum Jena

    Jena, 07747, Germany

  • Universitätsklinikum Köln

    Cologne, Berlin-kölnische Allee, 50969, Germany

  • Universitätsklinikum Köln

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Universitätsklinikum Schleswig-Holstein Campus Kiel

    Kiel, 24105, Germany

  • Universitätsklinikum Schleswig-Holstein Campus Lübeck

    Lübeck, 23538, Germany

  • Weill Cornell Medicine/ New York-Presbyterian Hospital

    New York, New York, 10065, United States

  • West Virginia University Hospital

    Morgantown, West Virginia, 26506, United States

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