RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-03-03
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07131631

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 1. Concomitant PCI and TEER
  2. 2. Congenital heart disease
  3. 3. Stage D heart failure
  4. 4. Uncontrolled atrial fibrillation
  5. 5. Pregnancy
  6. 6. \> moderate tricuspid regurgitation
  7. 7. \>moderate aortic regurgitation or stenosis
  8. 8. Contraindications or unable to undergo CMR
  9. 9. Prior mitral valve repair or replacement

Contacts and Locations

Study Contact

João Cavalcante, MD
CONTACT
612-863-3900
joao.cavalcante@allina.com
Sarah Schwager, RN
CONTACT
612-863-6257
sarah.schwager@allina.com

Principal Investigator

João Cavalcante, MD
PRINCIPAL_INVESTIGATOR
Minneapolis Heart Institute Foundation

Study Locations (Sites)

Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
United States
Mount Sinai Fuster Heart Hospital
New York, New York, 10029
United States
Sanger Heart and Vascular Institute
Charlotte, North Carolina, 28204
United States
The Christ Hospital Health Network
Cincinnati, Ohio, 45219
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042
United States

Collaborators and Investigators

Sponsor: Minneapolis Heart Institute Foundation

  • João Cavalcante, MD, PRINCIPAL_INVESTIGATOR, Minneapolis Heart Institute Foundation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-03
Study Completion Date2027-07

Study Record Updates

Study Start Date2022-03-03
Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

  • heart failure
  • reduced ejection fraction
  • functional mitral regurgitation

Additional Relevant MeSH Terms

  • Heart Failure and Reduced Ejection Fraction
  • Functional Mitral Regurgitation