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Can a tiny clip fix a leaky heart valve and spare patients from Open-Heart surgery?

NCT ID NCT04430075

Disease control Sponsor: Edwards Lifesciences 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This study is testing a device called PASCAL, which is used to repair a leaky mitral valve in the heart without open-heart surgery. The procedure involves guiding a small clip through a blood vessel to the heart to help the valve close properly. Researchers are following about 1,000 patients across Europe to see how safe the device is and how well it reduces the severity of the leak, with a focus on any major complications within the first month and the degree of improvement in valve function.

What this could mean

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

Active substance
Edwards PASCAL and PASCAL Precision transcatheter valve repair systems (devices used to clip and repair a leaky mitral valve without open-heart surgery)
What this could lead to
If successful, this could confirm that the PASCAL device is a safe and effective option for people with mitral regurgitation who are not candidates for open-heart surgery, potentially improving their symptoms and quality of life.
What could go wrong
This is a post-market study, meaning the device is already approved, but it is still being monitored for rare or long-term complications. The procedure carries risks like bleeding, infection, or damage to the heart, and the device may not fully fix the leak in all patients.

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.

Participants

About 1,000 people

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

Started

Aug 2019

Expected to finish

Mar 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.

Who is studied

Patients at or over the age of 18 determined to require percutaneous reconstruction of an insufficient mitral valve \[MR ≥ 2+ (PASCAL patients) or MR ≥ 3+ (PASCAL Precision patients)\] by a Heart Team who assesses patient risk and anatomic suitability should be considered for inclusion in this trial.

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. Mitral TEER patients eligible per the current approved indication after Heart Team discussion and agreement 2. Patient is willing and able to attend all follow-up visits and to perform all tests 3. Provision of written informed consent Exclusion Criteria: 1. Patients are not eligible per the current Instructions for Use 2. Non-elective or emergency TEER procedure for mitral regurgitation 3. Patients in ICU prior to the index procedure

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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 insufficiency Mitral regurgitation

Contacts and locations

Locations

  • Charité Berlin

    Berlin, 10117, Germany

  • Charité Berlin

    Berlin, 13353, Germany

  • Contilia Herz- und Gefäßzentrum,Elisabeth-Krankenhaus Essen

    Essen, Nordrhine Westfalia, 45138, Germany

  • Erasmus MC

    Rotterdam, 3015, Netherlands

  • Heart Centre of the University Leipzig

    Leipzig, 04289, Germany

  • Helios Klinikum Siegburg

    Siegburg, North Rhine-Westphalia, 53721, Germany

  • Herz- und Diabeteszentrum NRW - Bad Oeynhausen

    Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

  • Herzzentrum Universitaetsklinik Herzzentrum Universitaetsklinik Cologne

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Herzzentrum Universitätsklinik Dresden

    Dresden, Saxony, 01307, Germany

  • Hospital Alvaro Cunqueiro

    Vigo, 36213, Spain

  • Hygeia Hospital

    Athens, 151 23, Greece

  • IRCCS Ospedale San Raffaele

    Milan, Lombardy, 20132, Italy

  • IRCCS Policlinico San Donato

    San Donato Milanese, 20097, Italy

  • Immanuel Klinikum Bernau

    Bernau bei Berlin, Brandenburg, 16321, Germany

  • Inselspital Bern

    Bern, 3010, Switzerland

  • Kath. Marienkrankenhaus Hamburg GmbH

    Hamburg, 22087, Germany

  • MVZ-CCB

    Frankfurt, 60389, Germany

  • Medizinische Klinik I- Campus Grosshadern

    München, Bavaria, 81377, Germany

  • Medizinische Universität Wien/AKH Wien

    Vienna, 1090, Austria

  • Ospedale del Cuore G. Pasquinucci Massa

    Massa, 54100, Italy

  • St. Antonius Ziekenhuis

    Nieuwegein, 3435, Netherlands

  • St.-Johannes-Hospital

    Dortmund, North Rhine-Westphalia, 44137, Germany

  • The Cardinal Stefan Wyszyński, Institute of Cardiology

    Warsaw, 04-628, Poland

  • Uniklinikum Erlangen

    Erlangen, Bavaria, 91054, Germany

  • Uniklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081, Germany

  • Universitaeres Herzzentrum Goettingen

    Göttingen, Lower Saxony, 37075, Germany

  • Universitares Herzzentrum Hamburg

    Hamburg, 20246, Germany

  • Universitäres Herzzentrum Lübeck, Universitätsklinikum Schleswig-Holstein

    Lübeck, Schleswig-Holstein, 23538, Germany

  • Universität Tuebingen

    Tübingen, Baden-Wurttemberg, 72074, Germany

  • Universitäts-Herzzentrum Freiburg Campus Bad Krozingen

    Bad Krozingen, Baden-Wurttemberg, 79189, Germany

  • Universitätsklinikum Bonn

    Bonn, North Rhine-Westphalia, 32545, Germany

  • Universitätsklinikum Giessen UKGM

    Giessen, Hesse, 35392, Germany

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24105, Germany

  • Universitätsmedizin der Johannes Gutenberg Universität Mainz

    Mainz, North Rhine-Westphalia, 55313, Germany

  • Westdeutsches Herzzentrum / Uniklinik Essen

    Essen, Nordrhine Westfalia, 45122, Germany

  • Wythenshawe Hospital

    Manchester, M23 9LT, United Kingdom

  • Zentralklinik Bad Berka GmbH

    Bad Berka, 99438, Germany

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