Secondary Mitral Regurgitation Treatment With MitraClip and Assessment by Cardiac Magnetic Resonance
Recruiting now
Conditions studied: Heart Failure and Reduced Ejection Fraction, Functional Mitral Regurgitation
In brief
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.
Key facts
- Study ID
- NCT07131631
- Run by
- Minneapolis Heart Institute Foundation
- People needed
- 125
- Starts
- 2022-03-03
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2025-12-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States (enrolling)
- 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
Full record on ClinicalTrials.gov
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