MitraClip for secondary (functional) mitral regurgitation with cardiac MRI scar measurement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.