Early Transcatheter Mitral Valve Repair After Myocardial Infarction

Overview

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.

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).

Interventions

• Procedure 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.
• Device MitraClip
  MitraClip
• Other Optimal medical treatment
  Optimal medical treatment

Primary outcome measures

• All-cause death or Cumulative Heart Failure hospitalizations [Time frame: 12 months]

Eligibility criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Spain · 15 centers

• 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
• … and 7 more centers

Netherlands · 8 centers

• 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

Italy · 5 centers

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

Israel · 4 centers

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

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. 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

Identifiers

NCT: NCT06282042 · EMCAMI

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗