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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

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 site
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Sarah Schwager, RNsarah.schwager@allina.com

North Carolina

1 site
Sanger Heart and Vascular Institute
Charlotte, North Carolina, 28204

Ohio

2 sites
The Christ Hospital Health Network
Cincinnati, Ohio, 45219
Cleveland Clinic
Cleveland, Ohio, 44195

Virginia

1 site
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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