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RecruitingNCT06282042EMCAMIUpdated Oct 20, 2025

Early Transcatheter Mitral Valve Repair After Myocardial Infarction

An interventional study of Early transcatheter edge-to-edge mitral valve repair (TEER). and MitraClip in Acute Mitral Regurgitation, sponsored by Fundación para la Investigación Biosanitaria del Principado de Asturias. Recruiting at 32 sites in 4 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-10-20.

Sponsored by Fundación para la Investigación Biosanitaria del Principado de Asturias · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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 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).

02

Conditions studied

  • Acute Mitral Regurgitation

Keywords

  • MitraClip
03

In context

Lead sponsor

Fundación para la Investigación Biosanitaria del Principado de Asturias is the lead sponsor of 12 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Primary MR (e.g. papillary muscle rupture)
  • EF ≤ 25%
  • Accepted for CABG
  • Presence of cardiogenic shock (AMR type 1)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
250 participants (estimated)

Study arms

  • Experimental
    TEER + OMT

    Early transcatheter edge-to-edge mitral valve repair (TEER) plus optimal medical treatment

    Procedure: Early transcatheter edge-to-edge mitral valve repair (TEER). · Device: MitraClip · Other: Optimal medical treatment

  • Other
    OMT

    Optimal medical treatment

    Other: Optimal medical treatment

Interventions

  • ProcedureEarly 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.

  • DeviceMitraClip

    MitraClip

  • OtherOptimal medical treatment

    Optimal medical treatment

06

What researchers measure

Primary outcomes

  1. All-cause death or Cumulative Heart Failure hospitalizations

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

    Time frame: 12 months

07

Study locations

2 of 32 sites recruiting
  • Emek Medical Center
    Afula, Afula 1834111, Israel
    Not yet recruiting
  • Shaare Zedek Medical Center
    Jerusalem, Jerusalen 9103102, Israel
    • Mony Shuvy · Contact
    • Dr. Mony Shuvy · Principal investigator
    Recruiting
  • Rabin Medical Center
    Petah Tikva, Petah Tikva 4941492, Israel
    • Leor Perl · Contact
    • Dr. Leor Perl · Principal investigator
    Not yet recruiting
  • Sheba Medical Center
    Ramat Gan, Ramat Gan, Israel
    • Paul Fefer · Contact
    • Dr. Paul Fefer · Principal investigator
    Not yet recruiting
  • Civil Hospital of Brescia
    Brescia, Brescia 25123, Italy
    • Marianna Adamo · Contact
    • Dra. Marianna Adamo · Principal investigator
    Not yet recruiting
  • Ospedale Policlinico San Martino
    Genova, Genova 16132, Italy
    Not yet recruiting
  • San Raffaele Hospital
    Milan, Milano 20132, Italy
    • Cosmo Godino · Contact
    • Dr. Cosmo Godino · Principal investigator
    • Dr. Francesco Maisano · Principal investigator
    Not yet recruiting
  • Centro Cardiológico Monzino
    Milan, Milan 20138, Italy
    Not yet recruiting
  • Policlínico San Donato
    San Donato Milanese, San Donato Milanese 20097, Italy
    • Francesco Bedogni · Contact
    • Dr. Francesco Bedogni · Principal investigator
    Not yet recruiting
  • Amsterdam University Medical Center
    Amsterdam, Amsterdam 1081 HV, Netherlands
    • R. Delewi · Contact
    • Dr. R. Delewi · Principal investigator
    Not yet recruiting
  • Amphia Hospital
    Breda, Breda 4818 CK, Netherlands
    • B. van der Branden · Contact
    • Dr. B. van der Branden · Principal investigator
    Not yet recruiting
  • Catharina Ziekenhuis Hospital
    Eindhoven, Eindhoven 5623 EJ, Netherlands
    • P. Tonino · Contact
    • Dr. P. Tonino · Principal investigator
    Not yet recruiting
  • Leiden University Medical Center
    Leiden, Leiden 2333 ZA, Netherlands
    • F. van der Kley · Contact
    • Dr. F. van der Kley · Principal investigator
    Not yet recruiting
  • Maastricht University Medical Center
    Maastricht, Maastricht 6229 HX, Netherlands
    • P.A. Vriesendorp · Contact
    • Dr. P.A. Vriesendorp · Principal investigator
    Not yet recruiting
  • St. Antonius Hospital
    Nieuwegein, Nieuwegein 3435 CM, Netherlands
    • L. Timmers · Contact
    • Dr. L. Timmers · Principal investigator
    Not yet recruiting
  • Erasmus University Medical Center
    Rotterdam, Rotterdam 3015 GD, Netherlands
    • N. van Mieghem · Contact
    • Dr. N. van Mieghem · Principal investigator
    Not yet recruiting
  • Isala Hospital
    Zwolle, Zwolle 8025 AB, Netherlands
    • R. Hermanides · Contact
    • Dr. R. Hermanides · Principal investigator
    Not yet recruiting
  • Hospital General Universitario Dr. Balmis
    Alicante, Alicante 03010, Spain
    • José Valencia Martín, MD, PhD · Contact
    • José Valencia Martín, MD, PhD · Principal investigator
    Not yet recruiting
  • Hospital de la Santa Creu i Sant Pau
    Barcelona, Barcelona 08025, Spain
    • Dabit Arzamendi, MD, PhD · Contact
    • Dabit Arzamendi, MD, PhD · Principal investigator
    Not yet recruiting
  • Hospital Universitario Vall d'Hebrón
    Barcelona, Barcelona 08035, Spain
    • Bruno García del Blanco, MD, PhD · Contact
    • Dr. Bruno García del Blanco, MD, PhD · Principal investigator
    Not yet recruiting
  • Hospital Clínic Barcelona
    Barcelona, Barcelona 08036, Spain
    • Xavier Freixa Rofastes, MD, PhD · Contact
    • Dr. Xavier Freixa Rofastes, MD, PhD · Principal investigator
    Not yet recruiting
  • Hospital Universitario de Bellvitge
    L'Hospitalet de Llobregat, Barcelona 08907, Spain
    Not yet recruiting
  • Hospital Universitario Marqués de Valdecilla
    Santander, Cantabria 39008, Spain
    • Jose María de la Torre, MD, PhD · Contact
    • Dr. Jose María de la Torre, MD, PhD · Principal investigator
    Not yet recruiting
  • Hospital Universitario Reina Sofía
    Córdoba, Córdoba 14004, Spain
    • Manuel Pan Álvarez, MD, PhD · Contact
    • Dr. Manuel Pan Álvarez, MD, PhD · Principal investigator
    Not yet recruiting
  • Hospital Universitario Doctor Negrin
    Las Palmas de Gran Canaria, Las Palmas 35010, Spain
    • Pedro Martín, MD, PhD · Contact
    • Dr. Pedro Martín, MD, PhD · Principal investigator
    Not yet recruiting
  • Hospital Universitario Ramón y Cajal
    Madrid, Madrid 28034, Spain
    • Ángel Sánchez-Recalde, MD, PhD · Contact
    • Dr. Ángel Sánchez-Recalde, MD, PhD · Principal investigator
    Not yet recruiting
  • Hospital Clínico Universitario San Carlos
    Madrid, Madrid 28040, Spain
    • Luis Nombela, MD, PhD · Contact
    • Dr. Luis Nombela, MD, PhD · Principal investigator
    Not yet recruiting
  • Hospital Universitario Puerta de Hierro
    Madrid, Madrid 28222, Spain
    • María del Trigo, MD, PhD · Contact
    • Dra. María del Trigo, MD, PhD · Principal investigator
    Not yet recruiting
  • Hospital Universitario Virgen de la Victoria
    Málaga, Málaga 29010, Spain
    • Juan H. Alonso Briales, MD, PhD · Contact
    • Dr. Juan H. Alonso Briales, MD, PhD · Principal investigator
    Not yet recruiting
  • Hospital Álvaro Cunqueiro
    Vigo, Pontevedra 36312, Spain
    • Rodrigo Estévez-Loureiro, MD, PhD · Contact
    • Dr. Rodrigo Estévez-Loureiro, MD, PhD · Principal investigator
    Not yet recruiting
  • Hospital Universitario Central de Asturias (HUCA)
    Oviedo, Principality of Asturias 33011, Spain
    • Isaac Pascual Calleja, MD, PhD · Contact · ipascua@live.com · +34985101738
    • Isaac Pascual Calleja · Principal investigator
    Recruiting
  • Hospital Clínico Universitario de Valladolid
    Valladolid, Valladolid 47003, Spain
    • Ignacio Amat-Santos, MD, PhD · Contact
    • Dr. Ignacio Amat-Santos, MD, PhD · Principal investigator
    Not yet recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06282042
Lead sponsor
Fundación para la Investigación Biosanitaria del Principado de Asturias
Collaborators
Meditrial Europe Ltd.
Responsible party
Isaac Pascual Calleja (MD, PhD, Fundación para la Investigación Biosanitaria del Principado de Asturias) — Principal investigator
First posted
Feb 28, 2024
Start date
Dec 24, 2024
Primary completion
Jun 16, 2027 (estimated)
Completion
Jun 16, 2028 (estimated)
Last update
Oct 20, 2025

Study contacts

Isaac Pascual MD, PhD
Contact
ipascua@live.com
985101738
Pablo Avanzas, MD, PhD
Contact
avanzas@secardiologia.es
985101738
Isaac Pascual, MD, PhD
principal investigator · Hospital Universitario Central de Asturias

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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