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Clinical Trials in Italy / NCT06282042
Recruiting Not applicable

Early Transcatheter Mitral Valve Repair After Myocardial Infarction

NCT06282042 · tracked via the Priya Life Science Italy tracker
Sponsor
Fundación para la Investigación Biosanitaria del Principado de Asturias
Phase
Not applicable
Started
2024-12-24
Last updated
2025-10-20

Condition(s) studied

Acute Mitral Regurgitation

Investigational drug(s) / intervention(s)

Early transcatheter edge-to-edge mitral valve repair (TEER).MitraClipOptimal medical treatment

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.

MitraClip: MitraClip

Optimal medical treatment: Optimal medical treatment

Study 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

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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)

Primary outcome measure(s)

  • All-cause death or Cumulative Heart Failure hospitalizations — 12 months
    Composite of 1. All-cause death 2. Cumulative Heart Failure hospitalizations

Trial sites (32)

FacilityCityRegionStatus
Emek Medical Center Afula Afula Not Yet Recruiting
Shaare Zedek Medical Center Jerusalem Jerusalen Recruiting
Rabin Medical Center Petah Tikva Petah Tikva Not Yet Recruiting
Sheba Medical Center Ramat Gan Ramat Gan Not Yet Recruiting
Civil Hospital of Brescia Brescia Brescia Not Yet Recruiting
Ospedale Policlinico San Martino Genova Genova Not Yet Recruiting
San Raffaele Hospital Milan Milano Not Yet Recruiting
Centro Cardiológico Monzino Milan Milan Not Yet Recruiting
Policlínico San Donato San Donato Milanese San Donato Milanese Not Yet Recruiting
Amsterdam University Medical Center Amsterdam Amsterdam Not Yet Recruiting
Amphia Hospital Breda Breda Not Yet Recruiting
Catharina Ziekenhuis Hospital Eindhoven Eindhoven Not Yet Recruiting
Leiden University Medical Center Leiden Leiden Not Yet Recruiting
Maastricht University Medical Center Maastricht Maastricht Not Yet Recruiting
St. Antonius Hospital Nieuwegein Nieuwegein Not Yet Recruiting
Erasmus University Medical Center Rotterdam Rotterdam Not Yet Recruiting
Isala Hospital Zwolle Zwolle Not Yet Recruiting
Hospital General Universitario Dr. Balmis Alicante Alicante Not Yet Recruiting
Hospital de la Santa Creu i Sant Pau Barcelona Barcelona Not Yet Recruiting
Hospital Universitario Vall d'Hebrón Barcelona Barcelona Not Yet Recruiting
Hospital Clínic Barcelona Barcelona Barcelona Not Yet Recruiting
Hospital Universitario de Bellvitge L'Hospitalet de Llobregat Barcelona Not Yet Recruiting
Hospital Universitario Marqués de Valdecilla Santander Cantabria Not Yet Recruiting
Hospital Universitario Reina Sofía Córdoba Córdoba Not Yet Recruiting
Hospital Universitario Doctor Negrin Las Palmas de Gran Canaria Las Palmas Not Yet Recruiting
Hospital Universitario Ramón y Cajal Madrid Madrid Not Yet Recruiting
Hospital Clínico Universitario San Carlos Madrid Madrid Not Yet Recruiting
Hospital Universitario Puerta de Hierro Madrid Madrid Not Yet Recruiting
Hospital Universitario Virgen de la Victoria Málaga Málaga Not Yet Recruiting
Hospital Álvaro Cunqueiro Vigo Pontevedra Not Yet Recruiting
Hospital Universitario Central de Asturias (HUCA) Oviedo Principality of Asturias Recruiting
Hospital Clínico Universitario de Valladolid Valladolid Valladolid Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06282042 on ClinicalTrials.gov ↗ ← All trials in Italy