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Acute Mitral RegurgitationEMCAMINCT06282042

Early Transcatheter Mitral Valve Repair After Myocardial Infarction

A study testing Early transcatheter edge-to-edge mitral valve repair (TEER)., MitraClip and Optimal medical treatment in people with Acute Mitral Regurgitation, run by Fundación para la Investigación Biosanitaria del Principado de Asturias at 32 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

To explore the impact of early transcatheter edge-to-edge repair of acute functional mitral regurgitation after myocardial infarction on the combined incidence of death and heart-failure associated hospitalisations at one-year follow-up, and quality of life and LV remodelling at two-year follow-up. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Acute Mitral Regurgitation
What is being tested?
Early transcatheter edge-to-edge mitral valve repair (TEER)., MitraClip and Optimal medical treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
32 sitesin 4 countries
Study dates
24 Dec 2024to 16 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:

Who cannot join

  • Primary MR (e.g. papillary muscle rupture)
  • EF ≤ 25%
  • Accepted for CABG
  • Presence of cardiogenic shock (AMR type 1)

Trial locations and contacts

32 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Isaac Pascual MD, PhD contact

985101738

ipascua@live.com

Pablo Avanzas, MD, PhD contact

985101738

avanzas@secardiologia.es

32 sites in 4 countries

Spain15 sites, 15 recruiting
  • Hospital General Universitario Dr. Balmis

    Alicante, Alicante, 03010

    José Valencia Martín, MD, PhD

    José Valencia Martín, MD, PhD

    Not yet recruiting
  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona, 08025

    Dabit Arzamendi, MD, PhD

    Dabit Arzamendi, MD, PhD

    Not yet recruiting
  • Hospital Universitario Vall d'Hebrón

    Barcelona, Barcelona, 08035

    Bruno García del Blanco, MD, PhD

    Dr. Bruno García del Blanco, MD, PhD

    Not yet recruiting
  • Hospital Clínic Barcelona

    Barcelona, Barcelona, 08036

    Xavier Freixa Rofastes, MD, PhD

    Dr. Xavier Freixa Rofastes, MD, PhD

    Not yet recruiting
  • Hospital Universitario Reina Sofía

    Córdoba, Córdoba, 14004

    Manuel Pan Álvarez, MD, PhD

    Dr. Manuel Pan Álvarez, MD, PhD

    Not yet recruiting
  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

    Gerard Roura, +34932607500, groura@bellvitgehospital.cat

    Gerard Roura

    Not yet recruiting
  • Hospital Universitario Doctor Negrin

    Las Palmas de Gran Canaria, Las Palmas, 35010

    Pedro Martín, MD, PhD

    Dr. Pedro Martín, MD, PhD

    Not yet recruiting
  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, 28034

    Ángel Sánchez-Recalde, MD, PhD

    Dr. Ángel Sánchez-Recalde, MD, PhD

    Not yet recruiting
  • Hospital Clínico Universitario San Carlos

    Madrid, Madrid, 28040

    Luis Nombela, MD, PhD

    Dr. Luis Nombela, MD, PhD

    Not yet recruiting
  • Hospital Universitario Puerta de Hierro

    Madrid, Madrid, 28222

    María del Trigo, MD, PhD

    Dra. María del Trigo, MD, PhD

    Not yet recruiting
  • Hospital Universitario Virgen de la Victoria

    Málaga, Málaga, 29010

    Juan H. Alonso Briales, MD, PhD

    Dr. Juan H. Alonso Briales, MD, PhD

    Not yet recruiting
  • Hospital Universitario Central de Asturias (HUCA)

    Oviedo, Principality of Asturias, 33011

    Isaac Pascual Calleja, MD, PhD, +34985101738, ipascua@live.com

    Isaac Pascual Calleja

    Recruiting
  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008

    Jose María de la Torre, MD, PhD

    Dr. Jose María de la Torre, MD, PhD

    Not yet recruiting
  • Hospital Clínico Universitario de Valladolid

    Valladolid, Valladolid, 47003

    Ignacio Amat-Santos, MD, PhD

    Dr. Ignacio Amat-Santos, MD, PhD

    Not yet recruiting
  • Hospital Álvaro Cunqueiro

    Vigo, Pontevedra, 36312

    Rodrigo Estévez-Loureiro, MD, PhD

    Dr. Rodrigo Estévez-Loureiro, MD, PhD

    Not yet recruiting

Other trials in Spain

Netherlands8 sites, 8 recruiting
  • Amsterdam University Medical Center

    Amsterdam, Amsterdam, 1081 HV

    R. Delewi

    Dr. R. Delewi

    Not yet recruiting
  • Amphia Hospital

    Breda, Breda, 4818 CK

    B. van der Branden

    Dr. B. van der Branden

    Not yet recruiting
  • Catharina Ziekenhuis Hospital

    Eindhoven, Eindhoven, 5623 EJ

    P. Tonino

    Dr. P. Tonino

    Not yet recruiting
  • Leiden University Medical Center

    Leiden, Leiden, 2333 ZA

    F. van der Kley

    Dr. F. van der Kley

    Not yet recruiting
  • Maastricht University Medical Center

    Maastricht, Maastricht, 6229 HX

    P.A. Vriesendorp

    Dr. P.A. Vriesendorp

    Not yet recruiting
  • St. Antonius Hospital

    Nieuwegein, Nieuwegein, 3435 CM

    L. Timmers

    Dr. L. Timmers

    Not yet recruiting
  • Erasmus University Medical Center

    Rotterdam, Rotterdam, 3015 GD

    N. van Mieghem

    Dr. N. van Mieghem

    Not yet recruiting
  • Isala Hospital

    Zwolle, Zwolle, 8025 AB

    R. Hermanides

    Dr. R. Hermanides

    Not yet recruiting

Other trials in Netherlands

Italy5 sites, 5 recruiting
  • Civil Hospital of Brescia

    Brescia, Brescia, 25123

    Marianna Adamo

    Dra. Marianna Adamo

    Not yet recruiting
  • Ospedale Policlinico San Martino

    Genova, Genova, 16132

    Italo Porto, +390105551, italo.porto@unige.it

    Italo Porto

    Not yet recruiting
  • San Raffaele Hospital

    Milan, Milano, 20132

    Cosmo Godino

    Dr. Cosmo Godino

    Not yet recruiting
  • Centro Cardiológico Monzino

    Milan, Milan, 20138

    Federico de Marco, +3902580021, federico.demarco@gmail.com

    Federico de Marco

    Not yet recruiting
  • Policlínico San Donato

    San Donato Milanese, San Donato Milanese, 20097

    Francesco Bedogni

    Dr. Francesco Bedogni

    Not yet recruiting

Other trials in Italy

Israel4 sites, 4 recruiting
  • Emek Medical Center

    Afula, Afula, 1834111

    Limor Bushari, +97246495000, limor_il@clalit.org.il

    Limor Bushari

    Not yet recruiting
  • Shaare Zedek Medical Center

    Jerusalem, Jerusalen, 9103102

    Mony Shuvy

    Dr. Mony Shuvy

    Recruiting
  • Rabin Medical Center

    Petah Tikva, Petah Tikva, 4941492

    Leor Perl

    Dr. Leor Perl

    Not yet recruiting
  • Sheba Medical Center

    Ramat Gan, Ramat Gan

    Paul Fefer

    Dr. Paul Fefer

    Not yet recruiting

Other trials in Israel

About this study

To explore the impact of early transcatheter edge-to-edge repair of acute functional mitral regurgitation after myocardial infarction on the combined incidence of death and heart-failure associated hospitalisations at one-year follow-up, and quality of life and LV remodelling at two-year follow-up.

Read the detailed description

Prospective, multicentre, randomised, open-label, comparative effectiveness clinical trial for the treatment of clinically significant functional mitral regurgitation within 60 days after acute myocardial infarction, who are treated per standard of care and who have been determined by the site's local heart team as inappropriate or too high risk for mitral valve surgery.

Eligible subjects will be randomized in a 1:1 ratio to the MitraClip device (intervention group) or to no MitraClip device (Control group).

Being tested
Early transcatheter edge-to-edge mitral valve repair (TEER)., MitraClip, Optimal medical treatment
Keywords
MitraClip

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early transcatheter edge-to-edge mitral valve repair (TEER).Procedure or surgery

    TEER will be planned and performed as soon as possible, but within 60 days after index myocardial infarction, and within 30 days of randomisation using the MitraClip device.

  • MitraClipDevice

    MitraClip

  • Optimal medical treatmentOther

    Optimal medical treatment

Study groups in NCT06282042
Study groupRoleWhat they receive
TEER + OMTExperimentalEarly transcatheter edge-to-edge mitral valve repair (TEER) plus optimal medical treatment
Receives: Procedure: Early transcatheter edge-to-edge mitral valve repair (TEER).; Device: MitraClip; Other: Optimal medical treatment
OMTOtherOptimal medical treatment
Receives: Other: Optimal medical treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause death or Cumulative Heart Failure hospitalizations

    Composite of

    1. All-cause death
    2. Cumulative Heart Failure hospitalizations

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2024
  2. Study start24 Dec 2024
  3. Primary completion16 Jun 2027 (estimated)
  4. Study completion16 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, multicentre, randomised, open-label, comparative effectiveness clinical trial for the treatment of clinically significant functional mitral regurgitation within 60 days after acute myocardial infarction, who are treated per standard of care and who have been determined by the site's local heart team as inappropriate or too high risk for mitral valve surgery.
Masking
None (open label)
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06282042
Sponsor's protocol ID
EMCAMI
Acronym
EMCAMI
Status last verified
Dec 2024
First submitted
21 Feb 2024
Last updated
20 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Pocock SJ, Ariti CA, Collier TJ, Wang D. The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities. Eur Heart J. 2012 Jan;33(2):176-82. doi: 10.1093/eurheartj/ehr352. Epub 2011 Sep 6.

    PubMed 21900289
  • Finkelstein DM, Schoenfeld DA. Combining mortality and longitudinal measures in clinical trials. Stat Med. 1999 Jun 15;18(11):1341-54. doi: 10.1002/(sici)1097-0258(19990615)18:113.0.co;2-7.

    PubMed 10399200
  • Shuvy M, Maisano F, Strauss BH. Transcatheter Mitral Edge-to-Edge Repair for Treatment of Acute Mitral Regurgitation. Can J Cardiol. 2023 Oct;39(10):1382-1389. doi: 10.1016/j.cjca.2023.05.009. Epub 2023 May 18.

    PubMed 37209883
  • Shuvy M, von Bardeleben RS, Grasso C, Raake P, Lurz P, Zamorano JL, Asch F, Kar S, Maisano F; EXPAND Investigators. Safety and efficacy of MitraClip in acutely ill (NYHA Class IV) patients with mitral regurgitation: Results from the global EXPAND study. ESC Heart Fail. 2023 Apr;10(2):1122-1132. doi: 10.1002/ehf2.14273. Epub 2023 Jan 4.

    PubMed 36599332
  • Haberman D, Estevez-Loureiro R, Benito-Gonzalez T, Denti P, Arzamendi D, Adamo M, Freixa X, Nombela-Franco L, Villablanca P, Krivoshei L, Fam N, Spargias K, Czarnecki A, Pascual I, Praz F, Sudarsky D, Kerner A, Ninios V, Gennari M, Beeri R, Perl L, Wasserstrum Y, Danenberg H, Poles L, George J, Caneiro-Queija B, Scianna S, Moaraf I, Schiavi D, Scardino C, Corpataux N, Echarte-Morales J, Chrissoheris M, Fernandez-Peregrina E, Di Pasquale M, Regueiro A, Vergara-Uzcategui C, Iniguez-Romo A, Fernandez-Vazquez F, Dvir D, Maisano F, Taramasso M, Shuvy M. Conservative, surgical, and percutaneous treatment for mitral regurgitation shortly after acute myocardial infarction. Eur Heart J. 2022 Feb 12;43(7):641-650. doi: 10.1093/eurheartj/ehab496.

    PubMed 34463727
  • Jung RG, Simard T, Kovach C, Flint K, Don C, Di Santo P, Adamo M, Branca L, Valentini F, Benito-Gonzalez T, Fernandez-Vazquez F, Estevez-Loureiro R, Berardini A, Conti N, Rapezzi C, Biagini E, Parlow S, Shorr R, Levi A, Manovel A, Cardenal-Piris R, Diaz Fernandez J, Shuvy M, Haberman D, Sala A, Alkhouli MA, Marini C, Bargagna M, Schiavi D, Denti P, Markovic S, Buzzatti N, Chan V, Hynes M, Mesana T, Labinaz M, Pappalardo F, Taramasso M, Hibbert B. Transcatheter Mitral Valve Repair in Cardiogenic Shock and Mitral Regurgitation: A Patient-Level, Multicenter Analysis. JACC Cardiovasc Interv. 2021 Jan 11;14(1):1-11. doi: 10.1016/j.jcin.2020.08.037. Epub 2020 Oct 14.

    PubMed 33069653

Questions about this trial

What is this clinical trial studying?

A study testing Early transcatheter edge-to-edge mitral valve repair (TEER)., MitraClip and Optimal medical treatment in people with Acute Mitral Regurgitation, run by Fundación para la Investigación Biosanitaria del Principado de Asturias at 32 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Spain, Netherlands, Italy, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Isaac Pascual MD, PhD (985101738, ipascua@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause death or Cumulative Heart Failure hospitalizations (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06282042, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.

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