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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.
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).
Age
18 - 99 years
Sex
ALL
Healthy Volunteers
No
Emek Medical Center
Afula, Afula, Israel
Shaare Zedek Medical Center
Jerusalem, Jerusalen, Israel
Rabin Medical Center
Petah Tikva, Petah Tikva, Israel
Sheba Medical Center
Ramat Gan, Ramat Gan, Israel
Civil Hospital of Brescia
Brescia, Brescia, Italy
Ospedale Policlinico San Martino
Genova, Genova, Italy
San Raffaele Hospital
Milan, Milano, Italy
Centro Cardiológico Monzino
Milan, Milan, Italy
Policlínico San Donato
San Donato Milanese, San Donato Milanese, Italy
Amsterdam University Medical Center
Amsterdam, Amsterdam, Netherlands
Start Date
December 24, 2024
Primary Completion Date
June 16, 2027
Completion Date
June 16, 2028
Last Updated
October 20, 2025
250
ESTIMATED participants
Early transcatheter edge-to-edge mitral valve repair (TEER).
PROCEDURE
MitraClip
DEVICE
Optimal medical treatment
OTHER
Lead Sponsor
Fundación para la Investigación Biosanitaria del Principado de Asturias
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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