Secondary Mitral Regurgitation Treatment With MitraClip and Assessment by Cardiac Magnetic Resonance
Recruiting · NCT07131631 · Observational (researchers observe without assigning treatment) · Lead sponsor: Minneapolis Heart Institute Foundation
View the official record on ClinicalTrials.gov →Interventions studied
Cardiac MRI
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- \. 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
- 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
6 locations listed across 4 US states.
- Minneapolis Heart Institute Foundation - Minneapolis, Minnesota, United States
- 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