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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT06282042
Study type Interventional
Source Fundación para la Investigación Biosanitaria del Principado de Asturias
Contact Isaac Pascual MD, PhD
Phone 985101738
Email ipascua@live.com
Status Not yet recruiting
Phase Phase 4
Start date June 17, 2024
Completion date June 16, 2028