RecruitingNot ApplicableNCT06282042

Early Transcatheter Mitral Valve Repair After Myocardial Infarction

Sponsor

Fundación para la Investigación Biosanitaria del Principado de Asturias

Enrollment

250 participants

Start Date

Dec 24, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Mitral Regurgitation

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.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Early transcatheter edge-to-edge mitral valve repair (TEER)., a medical device called MitraClip, and others for people with acute mitral regurgitation. The study is currently recruiting participants at 32 locations. People eligible for this study include aged 18 Years to 99 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREEarly 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.

DEVICEMitraClip

MitraClip

OTHEROptimal medical treatment

Optimal medical treatment

Locations(32)

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

Amphia Hospital

Breda, Breda, Netherlands

Catharina Ziekenhuis Hospital

Eindhoven, Eindhoven, Netherlands

Leiden University Medical Center

Leiden, Leiden, Netherlands

Maastricht University Medical Center

Maastricht, Maastricht, Netherlands

St. Antonius Hospital

Nieuwegein, Nieuwegein, Netherlands

Erasmus University Medical Center

Rotterdam, Rotterdam, Netherlands

Isala Hospital

Zwolle, Zwolle, Netherlands

Hospital General Universitario Dr. Balmis

Alicante, Alicante, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Hospital Universitario Vall d'Hebrón

Barcelona, Barcelona, Spain

Hospital Clínic Barcelona

Barcelona, Barcelona, Spain

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Hospital Universitario Reina Sofía

Córdoba, Córdoba, Spain

Hospital Universitario Doctor Negrin

Las Palmas de Gran Canaria, Las Palmas, Spain

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Spain

Hospital Clínico Universitario San Carlos

Madrid, Madrid, Spain

Hospital Universitario Puerta de Hierro

Madrid, Madrid, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Málaga, Spain

Hospital Álvaro Cunqueiro

Vigo, Pontevedra, Spain

Hospital Universitario Central de Asturias (HUCA)

Oviedo, Principality of Asturias, Spain

Hospital Clínico Universitario de Valladolid

Valladolid, Valladolid, Spain

View Full Details on ClinicalTrials.gov

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NCT06282042