Early Transcatheter Mitral Valve Repair After Myocardial Infarction

Обзор

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.

Подробное описание

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).

Вмешательства

• Процедура 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.
• Устройство MitraClip
  MitraClip
• Другое Optimal medical treatment
  Optimal medical treatment

Первичные конечные точки

• All-cause death or Cumulative Heart Failure hospitalizations [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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:

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 15 центров

• Hospital General Universitario Dr. Balmis — Alicante
• Hospital de la Santa Creu i Sant Pau — Barcelona
• Hospital Universitario Vall d'Hebrón — Barcelona
• Hospital Clínic Barcelona — Barcelona
• Hospital Universitario de Bellvitge — L'Hospitalet de Llobregat
• Hospital Universitario Marqués de Valdecilla — Santander
• Hospital Universitario Reina Sofía — Córdoba
• Hospital Universitario Doctor Negrin — Las Palmas de Gran Canaria
• … и ещё 7 центров

Нидерланды · 8 центров

• Amsterdam University Medical Center — Amsterdam
• Amphia Hospital — Breda
• Catharina Ziekenhuis Hospital — Eindhoven
• Leiden University Medical Center — Leiden
• Maastricht University Medical Center — Maastricht
• St. Antonius Hospital — Nieuwegein
• Erasmus University Medical Center — Rotterdam
• Isala Hospital — Zwolle

Италия · 5 центров

• Civil Hospital of Brescia — Brescia
• Ospedale Policlinico San Martino — Genova
• San Raffaele Hospital — Milan
• Centro Cardiológico Monzino — Milan
• Policlínico San Donato — San Donato Milanese

Израиль · 4 центра

• Emek Medical Center — Afula
• Shaare Zedek Medical Center — Jerusalem
• Rabin Medical Center — Petah Tikva
• Sheba Medical Center — Ramat Gan

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 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, Chrissoher PMID 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 PMID 33069653

Идентификаторы

NCT: NCT06282042 · EMCAMI

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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