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