protocolSection identificationModule nctId: NCT06282042, orgStudyIdInfo id: EMCAMI, briefTitle: Early Transcatheter Mitral Valve Repair After Myocardial Infarction, acronym: EMCAMI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-17, primaryCompletionDateStruct date: 2027-06-16, completionDateStruct date: 2028-06-16, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Fundación para la Investigación Biosanitaria del Principado de Asturias, class: OTHER, collaborators name: Meditrial Europe Ltd., descriptionModule briefSummary: 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., conditionsModule conditions: Acute Mitral Regurgitation, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Early transcatheter edge-to-edge mitral valve repair (TEER)., interventions name: MitraClip, interventions name: Optimal medical treatment, outcomesModule primaryOutcomes measure: All-cause death or Cumulative Heart Failure hospitalizations, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shaare Zedek Medical Center, city: Jerusalem, state: Jerusalen, zip: 9103102, country: Israel, contacts name: Mony Shuvy, role: CONTACT, contacts name: Dr. Mony Shuvy, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.76904, lon: 35.21633, locations facility: Rabin Medical Center, city: Petah tikva, zip: 4941492, country: Israel, contacts name: Leor Perl, role: CONTACT, contacts name: Dr. Leor Perl, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.08707, lon: 34.88747, locations facility: Sheba Medical Center, city: Ramat Gan, country: Israel, geoPoint lat: 32.08227, lon: 34.81065, locations facility: Civil Hospital of Brescia, city: Brescia, zip: 25123, country: Italy, contacts name: Marianna Adamo, role: CONTACT, contacts name: Dra. Marianna Adamo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.53558, lon: 10.21472, locations facility: San Raffaele Hospital, city: Milano, zip: 20132, country: Italy, contacts name: Cosmo Godino, role: CONTACT, contacts name: Dr. Cosmo Godino, role: PRINCIPAL_INVESTIGATOR, contacts name: Dr. Francesco Maisano, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Policlínico San Donato, city: San Donato Milanese, zip: 20097, country: Italy, contacts name: Francesco Bedogni, role: CONTACT, contacts name: Dr. Francesco Bedogni, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.41047, lon: 9.26838, locations facility: Amsterdam University Medical Center, city: Amsterdam, zip: 1081 HV, country: Netherlands, contacts name: R. Delewi, role: CONTACT, contacts name: Dr. R. Delewi, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.37403, lon: 4.88969, locations facility: Amphia Hospital, city: Breda, zip: 4818 CK, country: Netherlands, contacts name: B. van der Branden, role: CONTACT, contacts name: Dr. B. van der Branden, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.58656, lon: 4.77596, locations facility: Catharina Ziekenhuis Hospital, city: Eindhoven, zip: 5623 EJ, country: Netherlands, contacts name: P. Tonino, role: CONTACT, contacts name: Dr. P. Tonino, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.44083, lon: 5.47778, locations facility: Leiden University Medical Center, city: Leiden, zip: 2333 ZA, country: Netherlands, contacts name: F. van der Kley, role: CONTACT, contacts name: Dr. F. van der Kley, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.15833, lon: 4.49306, locations facility: Maastricht University Medical Center, city: Maastricht, zip: 6229 HX, country: Netherlands, contacts name: P.A. Vriesendorp, role: CONTACT, contacts name: Dr. P.A. Vriesendorp, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.84833, lon: 5.68889, locations facility: St. Antonius Hospital, city: Nieuwegein, zip: 3435 CM, country: Netherlands, contacts name: L. Timmers, role: CONTACT, contacts name: Dr. L. Timmers, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.02917, lon: 5.08056, locations facility: Erasmus University Medical Center, city: Rotterdam, zip: 3015 GD, country: Netherlands, contacts name: N. van Mieghem, role: CONTACT, contacts name: Dr. N. van Mieghem, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.9225, lon: 4.47917, locations facility: Isala Hospital, city: Zwolle, zip: 8025 AB, country: Netherlands, contacts name: R. Hermanides, role: CONTACT, contacts name: Dr. R. Hermanides, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.5125, lon: 6.09444, locations facility: Hospital Universitario Marqués de Valdecilla, city: Santander, state: Cantabria, zip: 39008, country: Spain, contacts name: Jose María de la Torre, MD, PhD, role: CONTACT, contacts name: Dr. Jose María de la Torre, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.46472, lon: -3.80444, locations facility: Hospital Universitario Doctor Negrin, city: Las Palmas de Gran Canaria, state: Las Palmas, zip: 35010, country: Spain, contacts name: Pedro Martín, MD, PhD, role: CONTACT, contacts name: Dr. Pedro Martín, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.09973, lon: -15.41343, locations facility: Hospital Álvaro Cunqueiro, city: Vigo, state: Pontevedra, zip: 36312, country: Spain, contacts name: Rodrigo Estévez-Loureiro, MD, PhD, role: CONTACT, contacts name: Dr. Rodrigo Estévez-Loureiro, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.23282, lon: -8.72264, locations facility: Hospital General Universitario Dr. Balmis, city: Alicante, zip: 03010, country: Spain, contacts name: Juan M. Ruiz-Nodar, MD, PhD, role: CONTACT, contacts name: Juan M. Ruiz-Nodar, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.34517, lon: -0.48149, locations facility: Hospital de la Santa Creu i Sant Pau, city: Barcelona, zip: 08025, country: Spain, contacts name: Dabit Arzamendi, MD, PhD, role: CONTACT, contacts name: Dabit Arzamendi, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Hospital Universitario Vall d'Hebrón, city: Barcelona, zip: 08035, country: Spain, contacts name: Bruno García del Blanco, MD, PhD, role: CONTACT, contacts name: Dr. Bruno García del Blanco, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Hospital Clínic Barcelona, city: Barcelona, zip: 08036, country: Spain, contacts name: Xavier Freixa Rofastes, MD, PhD, role: CONTACT, contacts name: Dr. Xavier Freixa Rofastes, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Hospital Universitario Reina Sofía, city: Córdoba, zip: 14004, country: Spain, contacts name: Manuel Pan Álvarez, MD, PhD, role: CONTACT, contacts name: Dr. Manuel Pan Álvarez, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.89155, lon: -4.77275, locations facility: Hospital Universitario Ramón y Cajal, city: Madrid, zip: 28034, country: Spain, contacts name: Ángel Sánchez-Recalde, MD, PhD, role: CONTACT, contacts name: Dr. Ángel Sánchez-Recalde, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Clínico Universitario San Carlos, city: Madrid, zip: 28040, country: Spain, contacts name: Luis Nombela, MD, PhD, role: CONTACT, contacts name: Dr. Luis Nombela, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Universitario Puerta de Hierro, city: Madrid, zip: 28222, country: Spain, contacts name: María del Trigo, MD, PhD, role: CONTACT, contacts name: Dra. María del Trigo, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Universitario Virgen de la Victoria, city: Málaga, zip: 29010, country: Spain, contacts name: Juan H. Alonso Briales, MD, PhD, role: CONTACT, contacts name: Dr. Juan H. Alonso Briales, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.72016, lon: -4.42034, locations facility: Hospital Clínico Universitario de Valladolid, city: Valladolid, zip: 47003, country: Spain, contacts name: Ignacio Amat-Santos, MD, PhD, role: CONTACT, contacts name: Dr. Ignacio Amat-Santos, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.65518, lon: -4.72372, hasResults: False