Early Transcatheter Mitral Valve Repair After Myocardial Infarction

NCT06282042 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-10-17

No results posted yet for this 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.

Conditions

  • Acute Mitral Regurgitation

Interventions

PROCEDURE

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.

DEVICE

MitraClip

MitraClip

OTHER

Optimal medical treatment

Optimal medical treatment

Sponsors & Collaborators

  • Meditrial Europe Ltd.

    collaborator INDUSTRY
  • Fundación para la Investigación Biosanitaria del Principado de Asturias

    lead OTHER

Principal Investigators

  • Isaac Pascual, MD, PhD · Hospital Universitario Central de Asturias

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-24
Primary Completion
2027-06-16
Completion
2028-06-16
FDA Device
Yes

Countries

  • Israel
  • Italy
  • Netherlands
  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06282042 on ClinicalTrials.gov