RecruitingNot ApplicableNCT05292716

Mitral Regurgitation Treatment in Advanced Heart Failure

Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Enrollment

172 participants

Start Date

Apr 21, 2021

Study Type

INTERVENTIONAL

Conditions

Heart Failure Mitral Regurgitation

Summary

MITRADVANCE-HF is a prospective, randomized, parallel-controlled, open-label, multicentre study trial enrolling patients with SMR and advanced HF on maximally tolerated standard of care therapies for HF according to the most recent guidelines. Enrolled patients will be randomly assigned, in a 1:1 ratio, to a device arm consisting of MitraClip therapy added to optimal medical therapy (OMT) or a control arm of OMT alone. Approximately 20 Italian high-volume centres will be involved. Enrolment duration will be of 24 months. Follow-up visit will be performed at 3, 6, and 12 months. Primary end-point was the absolute change in overall KCCQ summary score (KCCQ-OS) from baseline to 3 months follow-up.

Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether repairing a leaky heart valve (mitral regurgitation) using a minimally invasive procedure (catheter-based repair, not open-heart surgery) improves outcomes in people with advanced heart failure who are already on maximum medical treatment. **You may be eligible if...** - You are between 18 and 90 years old - You have significant mitral regurgitation (a leaky mitral heart valve) confirmed by echocardiogram - You have advanced heart failure (severe symptoms like severe shortness of breath, despite being on optimal medications) - Your heart pumping function is very reduced (ejection fraction ≤35%) or your heart failure blood markers are very elevated - Your quality of life is significantly impacted by heart failure **You may NOT be eligible if...** - Your mitral regurgitation is not significant - Your heart failure is not advanced or you are not on optimal medical therapy - You have other structural heart problems preventing the procedure - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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