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Recruiting NCT07131631

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

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Trial Parameters

Condition Heart Failure and Reduced Ejection Fraction
Sponsor Minneapolis Heart Institute Foundation
Study Type OBSERVATIONAL
Phase N/A
Enrollment 125
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-03-03
Completion 2027-07
Interventions
Cardiac MRI

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Brief 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 Criteria

Inclusion Criteria: 1\. Adult patients (≥ 18 years old) with heart failure and reduced ejection fraction (LVEF \< 50% defined by echocardiography), medically and device-optimized according to guidelines, with significant FMR undergoing TEER with FDA-approved MitraClip device (Abbott Structural, USA) Exclusion Criteria: 1. Concomitant PCI and TEER 2. Congenital heart disease 3. Stage D heart failure 4. Uncontrolled atrial fibrillation 5. Pregnancy 6. \> moderate tricuspid regurgitation 7. \>moderate aortic regurgitation or stenosis 8. Contraindications or unable to undergo CMR 9. Prior mitral valve repair or replacement

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