Early Transcatheter Mitral Valve Repair After Myocardial Infarction
EMCAMI
1 other identifier
interventional
250
4 countries
32
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2024
Longer than P75 for not_applicable
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2024
CompletedFirst Posted
Study publicly available on registry
February 28, 2024
CompletedStudy Start
First participant enrolled
December 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 16, 2028
October 20, 2025
December 1, 2024
2.5 years
February 21, 2024
October 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All-cause death or Cumulative Heart Failure hospitalizations
Composite of 1. All-cause death 2. Cumulative Heart Failure hospitalizations
12 months
Study Arms (2)
TEER + OMT
EXPERIMENTALEarly transcatheter edge-to-edge mitral valve repair (TEER) plus optimal medical treatment
OMT
OTHEROptimal medical treatment
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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:
You may not qualify if:
- Primary MR (e.g. papillary muscle rupture)
- EF ≤ 25%
- Accepted for CABG
- Presence of cardiogenic shock (AMR type 1)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Emek Medical Center
Afula, Afula, 1834111, Israel
Shaare Zedek Medical Center
Jerusalem, Jerusalen, 9103102, Israel
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
Related Publications (6)
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: 21900289BACKGROUNDFinkelstein 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: 10399200BACKGROUNDShuvy 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: 37209883BACKGROUNDShuvy 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: 36599332BACKGROUNDHaberman 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.
PMID: 34463727BACKGROUNDJung 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.
PMID: 33069653BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Isaac Pascual, MD, PhD
Hospital Universitario Central de Asturias
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
February 21, 2024
First Posted
February 28, 2024
Study Start
December 24, 2024
Primary Completion (Estimated)
June 16, 2027
Study Completion (Estimated)
June 16, 2028
Last Updated
October 20, 2025
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share