Early Transcatheter Mitral Valve Repair After Myocardial Infarction (EMCAMI)

October 15, 2025 updated by: Isaac Pascual Calleja, Fundación para la Investigación Biosanitaria del Principado de Asturias
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
    • Afula
      • Afula, Afula, Israel, 1834111
        • Not yet recruiting
        • Emek Medical Center
        • Contact:
        • Principal Investigator:
          • Limor Bushari
    • Jerusalen
      • Jerusalem, Jerusalen, Israel, 9103102
        • Recruiting
        • Shaare Zedek Medical Center
        • Contact:
          • Mony Shuvy
        • Principal Investigator:
          • Dr. Mony Shuvy
    • Petah Tikva
      • Petah Tikva, Petah Tikva, Israel, 4941492
        • Not yet recruiting
        • Rabin Medical Center
        • Contact:
          • Leor Perl
        • Principal Investigator:
          • Dr. Leor Perl
    • Ramat Gan
      • Ramat Gan, Ramat Gan, Israel
        • Not yet recruiting
        • Sheba Medical Center
        • Contact:
          • Paul Fefer
        • Principal Investigator:
          • Dr. Paul Fefer
  • Italy
    • Brescia
      • Brescia, Brescia, Italy, 25123
        • Not yet recruiting
        • Civil Hospital of Brescia
        • Contact:
          • Marianna Adamo
        • Principal Investigator:
          • Dra. Marianna Adamo
    • Genova
      • Genova, Genova, Italy, 16132
        • Not yet recruiting
        • Ospedale Policlinico San Martino
        • Contact:
        • Principal Investigator:
          • Italo Porto
    • Milan
      • Milan, Milan, Italy, 20138
        • Not yet recruiting
        • Centro Cardiologico Monzino
        • Principal Investigator:
          • Federico de Marco
        • Contact:
    • Milano
      • Milan, Milano, Italy, 20132
        • Not yet recruiting
        • San Raffaele Hospital
        • Contact:
          • Cosmo Godino
        • Principal Investigator:
          • Dr. Cosmo Godino
        • Principal Investigator:
          • Dr. Francesco Maisano
    • San Donato Milanese
      • San Donato Milanese, San Donato Milanese, Italy, 20097
        • Not yet recruiting
        • Policlinico San Donato
        • Contact:
          • Francesco Bedogni
        • Principal Investigator:
          • Dr. Francesco Bedogni
  • Netherlands
    • Amsterdam
      • Amsterdam, Amsterdam, Netherlands, 1081 HV
        • Not yet recruiting
        • Amsterdam University Medical Center
        • Contact:
          • R. Delewi
        • Principal Investigator:
          • Dr. R. Delewi
    • Breda
      • Breda, Breda, Netherlands, 4818 CK
        • Not yet recruiting
        • Amphia Hospital
        • Contact:
          • B. van der Branden
        • Principal Investigator:
          • Dr. B. van der Branden
    • Eindhoven
      • Eindhoven, Eindhoven, Netherlands, 5623 EJ
        • Not yet recruiting
        • Catharina Ziekenhuis Hospital
        • Contact:
          • P. Tonino
        • Principal Investigator:
          • Dr. P. Tonino
    • Leiden
      • Leiden, Leiden, Netherlands, 2333 ZA
        • Not yet recruiting
        • Leiden University Medical Center
        • Contact:
          • F. van der Kley
        • Principal Investigator:
          • Dr. F. van der Kley
    • Maastricht
      • Maastricht, Maastricht, Netherlands, 6229 HX
        • Not yet recruiting
        • Maastricht University Medical Center
        • Contact:
          • P.A. Vriesendorp
        • Principal Investigator:
          • Dr. P.A. Vriesendorp
    • Nieuwegein
      • Nieuwegein, Nieuwegein, Netherlands, 3435 CM
        • Not yet recruiting
        • St. Antonius Hospital
        • Contact:
          • L. Timmers
        • Principal Investigator:
          • Dr. L. Timmers
    • Rotterdam
      • Rotterdam, Rotterdam, Netherlands, 3015 GD
        • Not yet recruiting
        • Erasmus University Medical Center
        • Contact:
          • N. van Mieghem
        • Principal Investigator:
          • Dr. N. van Mieghem
    • Zwolle
      • Zwolle, Zwolle, Netherlands, 8025 AB
        • Not yet recruiting
        • Isala Hospital
        • Contact:
          • R. Hermanides
        • Principal Investigator:
          • Dr. R. Hermanides
  • Spain
    • Alicante
      • Alicante, Alicante, Spain, 03010
        • Not yet recruiting
        • Hospital General Universitario Dr. Balmis
        • Contact:
          • José Valencia Martín, MD, PhD
        • Principal Investigator:
          • José Valencia Martín, MD, PhD
    • Barcelona
      • Barcelona, Barcelona, Spain, 08025
        • Not yet recruiting
        • Hospital De La Santa Creu I Sant Pau
        • Contact:
          • Dabit Arzamendi, MD, PhD
        • Principal Investigator:
          • Dabit Arzamendi, MD, PhD
      • Barcelona, Barcelona, Spain, 08035
        • Not yet recruiting
        • Hospital Universitario Vall d'Hebron
        • Contact:
          • Bruno García del Blanco, MD, PhD
        • Principal Investigator:
          • Dr. Bruno García del Blanco, MD, PhD
      • Barcelona, Barcelona, Spain, 08036
        • Not yet recruiting
        • Hospital Clinic Barcelona
        • Contact:
          • Xavier Freixa Rofastes, MD, PhD
        • Principal Investigator:
          • Dr. Xavier Freixa Rofastes, MD, PhD
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Not yet recruiting
        • Hospital Universitario de Bellvitge
        • Contact:
        • Principal Investigator:
          • Gerard Roura
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Not yet recruiting
        • Hospital Universitario Marqués de Valdecilla
        • Contact:
          • Jose María de la Torre, MD, PhD
        • Principal Investigator:
          • Dr. Jose María de la Torre, MD, PhD
    • Córdoba
      • Córdoba, Córdoba, Spain, 14004
        • Not yet recruiting
        • Hospital Universitario Reina Sofía
        • Contact:
          • Manuel Pan Álvarez, MD, PhD
        • Principal Investigator:
          • Dr. Manuel Pan Álvarez, MD, PhD
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
        • Not yet recruiting
        • Hospital Universitario Doctor Negrín
        • Contact:
          • Pedro Martín, MD, PhD
        • Principal Investigator:
          • Dr. Pedro Martín, MD, PhD
    • Madrid
      • Madrid, Madrid, Spain, 28034
        • Not yet recruiting
        • Hospital Universitario Ramón y Cajal
        • Contact:
          • Ángel Sánchez-Recalde, MD, PhD
        • Principal Investigator:
          • Dr. Ángel Sánchez-Recalde, MD, PhD
      • Madrid, Madrid, Spain, 28040
        • Not yet recruiting
        • Hospital Clinico Universitario San Carlos
        • Contact:
          • Luis Nombela, MD, PhD
        • Principal Investigator:
          • Dr. Luis Nombela, MD, PhD
      • Madrid, Madrid, Spain, 28222
        • Not yet recruiting
        • Hospital Universitario Puerta de Hierro
        • Contact:
          • María del Trigo, MD, PhD
        • Principal Investigator:
          • Dra. María del Trigo, MD, PhD
    • Málaga
      • Málaga, Málaga, Spain, 29010
        • Not yet recruiting
        • Hospital Universitario Virgen de la Victoria
        • Contact:
          • Juan H. Alonso Briales, MD, PhD
        • Principal Investigator:
          • Dr. Juan H. Alonso Briales, MD, PhD
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36312
        • Not yet recruiting
        • Hospital Alvaro Cunqueiro
        • Contact:
          • Rodrigo Estévez-Loureiro, MD, PhD
        • Principal Investigator:
          • Dr. Rodrigo Estévez-Loureiro, MD, PhD
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33011
        • Recruiting
        • Hospital Universitario Central de Asturias (HUCA)
        • Contact:
          • Isaac Pascual Calleja, MD, PhD
          • Phone Number: +34985101738
          • Email: ipascua@live.com
        • Principal Investigator:
          • Isaac Pascual Calleja
    • Valladolid
      • Valladolid, Valladolid, Spain, 47003
        • Not yet recruiting
        • Hospital Clínico Universitario de Valladolid
        • Contact:
          • Ignacio Amat-Santos, MD, PhD
        • Principal Investigator:
          • Dr. Ignacio Amat-Santos, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TEER + OMT
Early transcatheter edge-to-edge mitral valve repair (TEER) plus optimal medical treatment
Device: MitraClip
MitraClip
Procedure: Early transcatheter edge-to-edge mitral valve repair (TEER).
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.
Other: Optimal medical treatment
Optimal medical treatment
Other: OMT
Optimal medical treatment
Other: Optimal medical treatment
Optimal medical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause death or Cumulative Heart Failure hospitalizations
Time Frame: 12 months

Composite of

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación para la Investigación Biosanitaria del Principado de Asturias

Collaborators

Meditrial Europe Ltd.

Investigators

  • Principal Investigator: Isaac Pascual, MD, PhD, Hospital Universitario Central de Asturias

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 24, 2024

Primary Completion (Estimated)

June 16, 2027

Study Completion (Estimated)

June 16, 2028

Study Registration Dates

First Submitted

February 21, 2024

First Submitted That Met QC Criteria

February 27, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

October 20, 2025

Last Update Submitted That Met QC Criteria

October 15, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMCAMI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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