NCT06282042

Early Transcatheter Mitral Valve Repair After Myocardial Infarction

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Fundación para la Investigación Biosanitaria del Principado de Asturias · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Acute Mitral Regurgitation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-12-24
• Primary completion: 2027-06-16
• Completion: 2028-06-16
• First posted: 2024-02-28
• Last updated: 2025-10-20

Locations

32 sites across 4 countries: Israel, Italy, Netherlands, Spain

Regulatory

• FDA-regulated device study