MitraClip for secondary (functional) mitral regurgitation with cardiac MRI scar measurement
Secondary Mitral Regurgitation Treatment With MitraClip and Assessment by Cardiac Magnetic Resonance
The study will try to see if the amount of scar (fibrosis) seen on cardiac MRI predicts left‑ventricular recovery and clinical outcomes after MitraClip in people with heart failure and reduced ejection fraction.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 125 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Minneapolis Heart Institute Foundation Academic / other |
| Locations | 6 sites (Minneapolis, Minnesota and 5 other locations) |
| Trial ID | NCT07131631 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter observational cohort of up to 125 patients (target 100 evaluable at 6 months) undergoing guideline-directed transcatheter edge-to-edge repair (TEER) with the FDA‑approved MitraClip. Enrolled patients will have a clinically indicated baseline cardiac MRI with gadolinium within 90 days before the TEER procedure and will complete a baseline KCCQ quality-of-life questionnaire. At six months post-TEER patients will repeat the cardiac MRI, transthoracic echocardiogram, and KCCQ, with blood taken for hematocrit to allow extracellular volume (ECV) calculation. Electronic health records and yearly phone follow-up will be used for up to three years to capture clinical events such as heart-failure hospitalization, IV inotrope use, LVAD implantation, transplant, or death.
Who should consider this trial
Good fit: Adults (≥18) with heart failure and reduced ejection fraction (LVEF <50%), medically and device optimized, who have significant functional mitral regurgitation and are scheduled to undergo TEER with the FDA‑approved MitraClip and can undergo cardiac MRI.
Not a fit: Patients who cannot undergo CMR, have prior mitral valve repair or replacement, stage D heart failure, uncontrolled atrial fibrillation, or more than moderate other valvular disease are excluded and unlikely to benefit from the study findings.
Why it matters
Potential benefit: If successful, the approach could help doctors predict who is most likely to experience reverse remodeling and better outcomes after MitraClip, improving patient selection and counseling.
How similar studies have performed: Large randomized trials like COAPT have shown benefit of MitraClip in selected patients and separate CMR studies have linked myocardial fibrosis to outcomes, but using CMR-measured fibrosis specifically to predict reverse remodeling after TEER is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Minneapolis, Minnesota and 5 other locations
- Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States (Recruiting)
- Sanger Heart and Vascular Institute — Charlotte, North Carolina, United States (Enrolling_by_invitation)
- The Christ Hospital Health Network — Cincinnati, Ohio, United States (Enrolling_by_invitation)
- Cleveland Clinic — Cleveland, Ohio, United States (Enrolling_by_invitation)
- Inova Fairfax Medical Campus — Falls Church, Virginia, United States (Enrolling_by_invitation)
- IRCCS Ospedale San Raffaele — Milan, Italy (Enrolling_by_invitation)
Study contacts
- Principal investigator: João Cavalcante, MD — Minneapolis Heart Institute Foundation
- Study coordinator: João Cavalcante, MD
- Email: joao.cavalcante@allina.com
- Phone: 612-863-3900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.