Early Transcatheter Mitral Valve Repair After Myocardial Infarction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-24

Study Completion Date

2028-06-16

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Acute Mitral Regurgitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TEER + OMT

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

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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

Intervention Type DEVICE

MitraClip

Optimal medical treatment

Intervention Type OTHER

Optimal medical treatment

OMT

Optimal medical treatment

Group Type OTHER

Optimal medical treatment

Intervention Type OTHER

Optimal medical treatment

Interventions

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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.

Intervention Type PROCEDURE

MitraClip

Intervention Type DEVICE

Optimal medical treatment

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Isaac Pascual Calleja

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Isaac Pascual, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Central de Asturias

Locations

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