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Secondary Mitral Regurgitation Treatment With MitraClip and Assessment by Cardiac Magnetic Resonance
RECRUITINGSponsored by Minneapolis Heart Institute Foundation
Actively Recruiting
SponsorMinneapolis Heart Institute Foundation
Started2022-03-03
Est. completion2027-07
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations5 sites
View on ClinicalTrials.gov →
NCT07131631
Summary
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.
Eligibility
Age: 18 Years+Healthy volunteers accepted
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
Conditions3
Functional Mitral RegurgitationHeart DiseaseHeart Failure and Reduced Ejection Fraction
Locations5 sites
Minnesota
1 siteMinneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Sarah Schwager, RNsarah.schwager@allina.com
North Carolina
1 siteSanger Heart and Vascular Institute
Charlotte, North Carolina, 28204
Ohio
2 sitesThe Christ Hospital Health Network
Cincinnati, Ohio, 45219
Cleveland Clinic
Cleveland, Ohio, 44195
Virginia
1 siteInova Fairfax Medical Campus
Falls Church, Virginia, 22042
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Actively Recruiting
SponsorMinneapolis Heart Institute Foundation
Started2022-03-03
Est. completion2027-07
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations5 sites
View on ClinicalTrials.gov →
NCT07131631