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

Heart Failure and Reduced Ejection Fraction Functional Mitral Regurgitation

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

Inclusion Criteria1

\. 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 Criteria9

Concomitant PCI and TEER
Congenital heart disease
Stage D heart failure
Uncontrolled atrial fibrillation
Pregnancy
\> moderate tricuspid regurgitation
\>moderate aortic regurgitation or stenosis
Contraindications or unable to undergo CMR
Prior mitral valve repair or replacement

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.