RECRUITING

Secondary Mitral Regurgitation Treatment With MitraClip and Assessment by Cardiac Magnetic Resonance

Description

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.

Conditions

Heart Failure and Reduced Ejection FractionFunctional Mitral Regurgitation
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Related Conditions:

Heart Failure and Reduced Ejection FractionFunctional Mitral Regurgitation

Study Overview

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Study Details

Study overview

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.

Secondary Mitral Regurgitation Treatment With MitraClip and Assessment by Cardiac Magnetic Resonance

Secondary Mitral Regurgitation Treatment With MitraClip and Assessment by Cardiac Magnetic Resonance

Condition
Heart Failure and Reduced Ejection Fraction
Intervention / Treatment

-

Contacts and Locations

Minneapolis

Minneapolis Heart Institute Foundation, Minneapolis, Minnesota, United States, 55407

New York

Mount Sinai Fuster Heart Hospital, New York, New York, United States, 10029

Charlotte

Sanger Heart and Vascular Institute, Charlotte, North Carolina, United States, 28204

Cincinnati

The Christ Hospital Health Network, Cincinnati, Ohio, United States, 45219

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Falls Church

Inova Fairfax Medical Campus, Falls Church, Virginia, United States, 22042

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Minneapolis Heart Institute Foundation,

João Cavalcante, MD, PRINCIPAL_INVESTIGATOR, Minneapolis Heart Institute Foundation

Study Record Dates

2027-07