Actively Recruiting
Secondary Mitral Regurgitation Treatment With MitraClip and Assessment by Cardiac Magnetic Resonance
Led by Minneapolis Heart Institute Foundation · Updated on 2025-12-23
125
Participants Needed
6
Research Sites
278 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Secondary Mitral Regurgitation Treatment With MitraClip and Assessment by Cardiac Magnetic Resonance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients (18 years or older) with heart failure and reduced ejection fraction (LVEF < 50% by echocardiography)
- Medically and device-optimized according to guidelines
- Significant functional mitral regurgitation (FMR) undergoing TEER with FDA-approved MitraClip device (Abbott Structural, USA)
You will not qualify if you...
- Concomitant PCI and TEER procedures
- Congenital heart disease
- Stage D heart failure
- Uncontrolled atrial fibrillation
- Pregnancy
- More than moderate tricuspid regurgitation
- More than moderate aortic regurgitation or stenosis
- Contraindications or inability to undergo CMR
- Prior mitral valve repair or replacement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
2
Sanger Heart and Vascular Institute
Charlotte, North Carolina, United States, 28204
Enrolling by Invitation
3
The Christ Hospital Health Network
Cincinnati, Ohio, United States, 45219
Enrolling by Invitation
4
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Enrolling by Invitation
5
Inova Fairfax Medical Campus
Falls Church, Virginia, United States, 22042
Enrolling by Invitation
6
IRCCS Ospedale San Raffaele
Milan, Italy, 20132
Enrolling by Invitation
Research Team
J
João Cavalcante, MD
CONTACT
S
Sarah Schwager, RN
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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