NCT06282042|RecruitingDMCFDA Device
Early Transcatheter Mitral Valve Repair After Myocardial Infarction
EMCAMI
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Sponsor study identifier
interventional
250
4 countries
32
Study Start
December 24, 2024
Actual (reported)Primary Completion
June 16, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 16, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 16, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 21, 2024
Actual (reported)February 28, 2024
Actual (reported)December 24, 2024
Actual (reported)June 16, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 16, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
All-cause death or Cumulative Heart Failure hospitalizations
Composite of 1. All-cause death 2. Cumulative Heart Failure hospitalizations
12 months
Early transcatheter edge-to-edge mitral valve repair (TEER) plus optimal medical treatment
Optimal medical treatment
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.
MitraClip
Emek Medical Center
Afula, Afula, 1834111, Israel
Shaare Zedek Medical Center
Jerusalem, Jerusalen, 9103102, Israel
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.
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.
Isaac Pascual, MD, PhD
Hospital Universitario Central de Asturias
First Submitted
February 21, 2024
First Posted
February 28, 2024
Study Start
December 24, 2024
Actual (reported)Optimal medical treatment
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Rabin Medical Center
Petah Tikva, Petah Tikva, 4941492, Israel
Sheba Medical Center
Ramat Gan, Ramat Gan, Israel
Civil Hospital of Brescia
Brescia, Brescia, 25123, Italy
Ospedale Policlinico San Martino
Genova, Genova, 16132, Italy
San Raffaele Hospital
Milan, Milano, 20132, Italy
Centro Cardiológico Monzino
Milan, Milan, 20138, Italy
Policlínico San Donato
San Donato Milanese, San Donato Milanese, 20097, Italy
Amsterdam University Medical Center
Amsterdam, Amsterdam, 1081 HV, Netherlands
Amphia Hospital
Breda, Breda, 4818 CK, Netherlands
Catharina Ziekenhuis Hospital
Eindhoven, Eindhoven, 5623 EJ, Netherlands
Leiden University Medical Center
Leiden, Leiden, 2333 ZA, Netherlands
Maastricht University Medical Center
Maastricht, Maastricht, 6229 HX, Netherlands
St. Antonius Hospital
Nieuwegein, Nieuwegein, 3435 CM, Netherlands
Erasmus University Medical Center
Rotterdam, Rotterdam, 3015 GD, Netherlands
Isala Hospital
Zwolle, Zwolle, 8025 AB, Netherlands
Hospital General Universitario Dr. Balmis
Alicante, Alicante, 03010, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025, Spain
Hospital Universitario Vall d'Hebrón
Barcelona, Barcelona, 08035, Spain
Hospital Clínic Barcelona
Barcelona, Barcelona, 08036, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Universitario Reina Sofía
Córdoba, Córdoba, 14004, Spain
Hospital Universitario Doctor Negrin
Las Palmas de Gran Canaria, Las Palmas, 35010, Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, 28034, Spain
Hospital Clínico Universitario San Carlos
Madrid, Madrid, 28040, Spain
Hospital Universitario Puerta de Hierro
Madrid, Madrid, 28222, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Málaga, 29010, Spain
Hospital Álvaro Cunqueiro
Vigo, Pontevedra, 36312, Spain
Hospital Universitario Central de Asturias (HUCA)
Oviedo, Principality of Asturias, 33011, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, 47003, Spain
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.
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.
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.
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.
Primary Completion
June 16, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 16, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 20, 2025
Record last verified: 2024-12
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