Early Transcatheter Mitral Valve Repair After Myocardial Infarction (EMCAMI)

Fundación para la Investigación Biosanitaria del Principado de Asturias

Status: Enrolling

Conditions: Acute Mitral Regurgitation

Treatments: Device: MitraClip; Other: Optimal medical treatment; Procedure: Early transcatheter edge-to-edge mitral valve repair (TEER).

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06282042

EMCAMI

Details and patient eligibility

About

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.

Full 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).

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

TEER + OMT

Experimental group

Description:

Early transcatheter edge-to-edge mitral valve repair (TEER) plus optimal medical treatment

Treatment:

Procedure: Early transcatheter edge-to-edge mitral valve repair (TEER).

Other: Optimal medical treatment

Device: MitraClip

OMT

Other group

Description:

Optimal medical treatment

Treatment:

Other: Optimal medical treatment