Early Transcatheter Mitral Valve Repair After Myocardial Infarction

Phase 4

Not yet recruiting

• Conditions: Acute Mitral Regurgitation
• Interventions: Procedure: Early transcatheter edge-to-edge mitral valve repair (TEER).; Device: MitraClip; Other: Optimal medical treatment

• Registration Number: NCT06282042
• Lead Sponsor: Fundación para la Investigación Biosanitaria del Principado de Asturias

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.

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).

Study Timeline

• Study First Submitted: 2024-02-21
• Study First Submitted QC: 2024-02-27
• Study First Posted: 2024-02-28
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24
• Study Start: 2024-06-17
• Primary Completion: 2027-06-16
• Study Completion: 2028-06-16

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TEER + OMT	MitraClip	Early transcatheter edge-to-edge mitral valve repair (TEER) plus optimal medical treatment
TEER + OMT	Optimal medical treatment	Early transcatheter edge-to-edge mitral valve repair (TEER) plus optimal medical treatment
OMT	Optimal medical treatment	Optimal medical treatment
TEER + OMT	Early transcatheter edge-to-edge mitral valve repair (TEER).	Early transcatheter edge-to-edge mitral valve repair (TEER) plus optimal medical treatment

Primary Outcome Measures

Name	Time	Method
All-cause death or Cumulative Heart Failure hospitalizations	12 months	Composite of; 1. All-cause death; 2. Cumulative Heart Failure hospitalizations

Trial Locations

Locations (27)

Hospital Clínic Barcelona; 🇪🇸 Barcelona, Spain

Hospital Álvaro Cunqueiro; 🇪🇸 Vigo, Pontevedra, Spain

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel

Hospital Universitario Doctor Negrin; 🇪🇸 Las Palmas de Gran Canaria, Las Palmas, Spain

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Jerusalen, Israel

Rabin Medical Center; 🇮🇱 Petah tikva, Israel

Civil Hospital of Brescia; 🇮🇹 Brescia, Italy

Policlínico San Donato; 🇮🇹 San Donato Milanese, Italy

San Raffaele Hospital; 🇮🇹 Milano, Italy

Amphia Hospital; 🇳🇱 Breda, Netherlands

Catharina Ziekenhuis Hospital; 🇳🇱 Eindhoven, Netherlands

Amsterdam University Medical Center; 🇳🇱 Amsterdam, Netherlands

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands

St. Antonius Hospital; 🇳🇱 Nieuwegein, Netherlands

Erasmus University Medical Center; 🇳🇱 Rotterdam, Netherlands

Isala Hospital; 🇳🇱 Zwolle, Netherlands

Hospital Universitario Marqués de Valdecilla; 🇪🇸 Santander, Cantabria, Spain

Hospital Universitario Vall d'Hebrón; 🇪🇸 Barcelona, Spain

Hospital General Universitario Dr. Balmis; 🇪🇸 Alicante, Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Universitario Reina Sofía; 🇪🇸 Córdoba, Spain

Hospital Universitario Virgen de la Victoria; 🇪🇸 Málaga, Spain

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital Universitario Puerta de Hierro; 🇪🇸 Madrid, Spain

Hospital Clínico Universitario de Valladolid; 🇪🇸 Valladolid, Spain

Hospital Clínico Universitario San Carlos; 🇪🇸 Madrid, Spain