RecruitingNCT07131631

Secondary Mitral Regurgitation Treatment With MitraClip and Assessment by Cardiac Magnetic Resonance


Sponsor

Minneapolis Heart Institute Foundation

Enrollment

125 participants

Start Date

Mar 3, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

This is a multi-center, prospective, observational study designed to evaluate the impact of LV myocardial fibrosis extent assessed by CMR on LV reverse remodeling and clinical outcomes post TEER. The target sample will be up to 125 patients enrolled to achieve 100 evaluable at 6 months of follow-up. Enrollment will occur at up to eight centers.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining people with heart failure and a leaky mitral valve (the valve between two chambers of the heart) who are being treated with a small clip device called MitraClip. Researchers want to understand how MRI scans of the heart can help track outcomes after this procedure. **You may be eligible if...** - You are 18 or older - You have heart failure with reduced pumping function (ejection fraction below 50%) - You have a significantly leaky mitral valve caused by heart failure (not a valve defect itself) - You are already scheduled to receive the MitraClip procedure - You are on the best possible medication and device treatment for your heart failure **You may NOT be eligible if...** - You are having a heart procedure (PCI) at the same time as the MitraClip - You have a congenital (birth) heart defect - You have end-stage (stage D) heart failure - You have uncontrolled atrial fibrillation - You are pregnant - You have significant problems with other heart valves - You cannot have an MRI scan - You have had a previous mitral valve repair or replacement 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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Interventions

DIAGNOSTIC_TESTCardiac MRI

Clinically indicated baseline CMR study with contrast up to 90 days before TEER procedure, including KCCQ questionnaire. At 6 months, participants will return for repeat of KCCQ, CMR study and a transthoracic echocardiogram. Blood samples, done as standard clinical care for hemotocrit for ECV calculation, will be obtained.


Locations(6)

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Sanger Heart and Vascular Institute

Charlotte, North Carolina, United States

The Christ Hospital Health Network

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Inova Fairfax Medical Campus

Falls Church, Virginia, United States

IRCCS Ospedale San Raffaele

Milan, Italy

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NCT07131631


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