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New trial tests quick valve fix after heart attack to save lives

NCT ID NCT06282042

Disease control Sponsor: Fundación para la Investigación Biosanitaria del Principado de Asturias 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether repairing a leaky mitral valve soon after a heart attack can lower the chances of death or repeat hospital stays for heart failure. About 250 adults with moderate-to-severe valve leakage will either get the MitraClip procedure within 60 days or standard medical care. Researchers will track outcomes for up to two years.

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
What this could lead to
If it works, this could reduce the risk of death and heart failure hospitalizations after a heart attack complicated by mitral regurgitation.
What could go wrong
This is a mid-sized trial without a placebo control, and the procedure carries risks like bleeding or device complications. Results may not apply to 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.

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 250 people

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

Started

Dec 2024

Expected to finish

Jun 2028

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

18 to 99 years

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: * Patients with symptomatic moderate to severe or severe MR after acute MI * Age \> 18 years * Based on the following classification recently published in "Transcatheter Mitral Edge-to-Edge Repair for Treatment of Acute Mitral Regurgitation" by M. Shuvy et al. (Can J Cardiol. 2023) patients will be included if categorized in Type 2, 3 or 4: Exclusion Criteria: * Primary MR (e.g. papillary muscle rupture) * EF ≤ 25% * Accepted for CABG * Presence of cardiogenic shock (AMR type 1)

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Conditions

The condition(s) this trial relates to.

mitral valve insufficiency myocardial infarction

As listed by the trial registrant

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

Acute 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

    32 sites in 4 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

  • Amphia Hospital

    NOT_YET_RECRUITING

    Breda, Breda, 4818 CK, Netherlands

  • Amsterdam University Medical Center

    NOT_YET_RECRUITING

    Amsterdam, Amsterdam, 1081 HV, Netherlands

  • Catharina Ziekenhuis Hospital

    NOT_YET_RECRUITING

    Eindhoven, Eindhoven, 5623 EJ, Netherlands

  • Centro Cardiológico Monzino

    NOT_YET_RECRUITING

    Milan, Milan, 20138, Italy

  • Civil Hospital of Brescia

    NOT_YET_RECRUITING

    Brescia, Brescia, 25123, Italy

  • Emek Medical Center

    NOT_YET_RECRUITING

    Afula, Afula, 1834111, Israel

  • Erasmus University Medical Center

    NOT_YET_RECRUITING

    Rotterdam, Rotterdam, 3015 GD, Netherlands

  • Hospital Clínic Barcelona

    NOT_YET_RECRUITING

    Barcelona, Barcelona, 08036, Spain

  • Hospital Clínico Universitario San Carlos

    NOT_YET_RECRUITING

    Madrid, Madrid, 28040, Spain

  • Hospital Clínico Universitario de Valladolid

    NOT_YET_RECRUITING

    Valladolid, Valladolid, 47003, Spain

  • Hospital General Universitario Dr. Balmis

    NOT_YET_RECRUITING

    Alicante, Alicante, 03010, Spain

  • Hospital Universitario Central de Asturias (HUCA)

    RECRUITING

    Oviedo, Principality of Asturias, 33011, Spain

  • Hospital Universitario Doctor Negrin

    NOT_YET_RECRUITING

    Las Palmas de Gran Canaria, Las Palmas, 35010, Spain

  • Hospital Universitario Marqués de Valdecilla

    NOT_YET_RECRUITING

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Puerta de Hierro

    NOT_YET_RECRUITING

    Madrid, Madrid, 28222, Spain

  • Hospital Universitario Ramón y Cajal

    NOT_YET_RECRUITING

    Madrid, Madrid, 28034, Spain

  • Hospital Universitario Reina Sofía

    NOT_YET_RECRUITING

    Córdoba, Córdoba, 14004, Spain

  • Hospital Universitario Vall d'Hebrón

    NOT_YET_RECRUITING

    Barcelona, Barcelona, 08035, Spain

  • Hospital Universitario Virgen de la Victoria

    NOT_YET_RECRUITING

    Málaga, Málaga, 29010, Spain

  • Hospital Universitario de Bellvitge

    NOT_YET_RECRUITING

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Hospital de la Santa Creu i Sant Pau

    NOT_YET_RECRUITING

    Barcelona, Barcelona, 08025, Spain

  • Hospital Álvaro Cunqueiro

    NOT_YET_RECRUITING

    Vigo, Pontevedra, 36312, Spain

  • Isala Hospital

    NOT_YET_RECRUITING

    Zwolle, Zwolle, 8025 AB, Netherlands

  • Leiden University Medical Center

    NOT_YET_RECRUITING

    Leiden, Leiden, 2333 ZA, Netherlands

  • Maastricht University Medical Center

    NOT_YET_RECRUITING

    Maastricht, Maastricht, 6229 HX, Netherlands

  • Ospedale Policlinico San Martino

    NOT_YET_RECRUITING

    Genova, Genova, 16132, Italy

  • Policlínico San Donato

    NOT_YET_RECRUITING

    San Donato Milanese, San Donato Milanese, 20097, Italy

  • Rabin Medical Center

    NOT_YET_RECRUITING

    Petah Tikva, Petah Tikva, 4941492, Israel

  • San Raffaele Hospital

    NOT_YET_RECRUITING

    Milan, Milano, 20132, Italy

  • Shaare Zedek Medical Center

    RECRUITING

    Jerusalem, Jerusalen, 9103102, Israel

  • Sheba Medical Center

    NOT_YET_RECRUITING

    Ramat Gan, Ramat Gan, Israel

  • St. Antonius Hospital

    NOT_YET_RECRUITING

    Nieuwegein, Nieuwegein, 3435 CM, Netherlands

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