Home › Trials › NCT06282042

Early transcatheter mitral valve repair after a heart attack

Early Transcatheter Mitral Valve Repair After Myocardial Infarction

Not applicable Interventional Fundación para la Investigación Biosanitaria del Principado de Asturias · NCT06282042

This trial will try an early MitraClip procedure in adults with moderate-to-severe mitral regurgitation within 60 days after a heart attack to see if it lowers death and hospital visits for heart failure.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment250 (estimated)
Ages18 Years to 99 Years
SexAll
SponsorFundación para la Investigación Biosanitaria del Principado de Asturias Academic / other
Locations32 sites (Afula, Afula and 31 other locations)
Trial IDNCT06282042 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, randomized, open-label trial comparing early transcatheter edge-to-edge repair (MitraClip) plus optimal medical therapy versus optimal medical therapy alone in patients with clinically significant functional mitral regurgitation within 60 days after acute myocardial infarction. Eligible patients are those judged by the local heart team to be too high risk for surgical repair and are randomized 1:1 to receive the MitraClip or no device. The primary combined endpoint is death and heart-failure–related hospitalization at one year, with quality of life and left ventricular remodeling assessed at two years. Patients with primary MR, very low ejection fraction, planned CABG, or cardiogenic shock are excluded.

Who should consider this trial

Good fit: Adults over 18 with symptomatic moderate-to-severe or severe functional mitral regurgitation within 60 days of an acute myocardial infarction who are judged by the site's heart team to be inappropriate or too high risk for mitral valve surgery (Type 2–4 classification).

Not a fit: Patients with primary MR (for example papillary muscle rupture), an ejection fraction ≤25%, those accepted for CABG, or those in cardiogenic shock are excluded and unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, early MitraClip repair could reduce deaths and heart-failure hospitalizations and improve quality of life and heart remodeling after an MI.

How similar studies have performed: Transcatheter edge-to-edge repair has demonstrated clear benefit in selected chronic functional MR populations, but its early use after acute MI is relatively novel and not yet supported by large randomized data.

Eligibility criteria

Show full inclusion / exclusion criteria 
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)

Where this trial is running

Afula, Afula and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Mitral RegurgitationMitraClip
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.