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

ID#: NCT07131631

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Recruitment Status: Recruiting

Start Date: March 03, 2022

End Date: July 01, 2027

Contact Information:
João Cavalcante, MD
612-863-3900
Sarah Schwager, RN
612-863-6257
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:

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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