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Secondary Mitral Regurgitation Treatment With MitraClip and Assessment by Cardiac Magnetic Resonance
NCT07131631 · Minneapolis Heart Institute Foundation
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
Patients undergoing guideline-directed TEER with FDA-approved MitraClip at the participating centers will be screened and recruited for study participation. After informed consent is obtained, patients will undergo a clinically-indicated baseline CMR study with gadolinium up to 90 days before TEER procedure. In addition, a quality-of-life surveillance questionnaire (KCCQ) will be completed at the same baseline visit.
Six months after TEER patients will return to clinic to repeat the quality of life surveillance questionnaire (KCCQ), the CMR study and a transthoracic echocardiogram. The 6-month CMR study and echocardiogram should be completed on the same day or no greater than 30 days apart if the same day is not feasible. Blood samples will be collected on the day of the CMR to provide the hematocrit for ECV calculation. These samples are done as standard clinical care.
Electronic Health Records (EHR) will be reviewed and phone contact performed yearly for up to three years after TEER to evaluate clinical outcomes (heart failure hospitalization, outpatient use of intravenous inotropes, LVAD implant, heart transplant, or death).
Eligibility criteria
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
Study design
Enrollment target: 125 participants
Age groups: adult, older_adult
Timeline
Starts: 2022-03-03
Estimated completion: 2027-07
Last updated: 2025-12-23
Interventions
Diagnostic Test: Cardiac MRI
Primary outcomes
- • Estimate the association between LV myocardial fibrosis by CMR late gadolinium enhancement imaging before TEER with LV reverse remodeling. (From enrollment to the end of 6 months)
Sponsor
Minneapolis Heart Institute Foundation · other
Contacts & investigators
ContactJoão Cavalcante, MD · contact · joao.cavalcante@allina.com · 612-863-3900
ContactSarah Schwager, RN · contact · sarah.schwager@allina.com · 612-863-6257
InvestigatorJoão Cavalcante, MD · principal_investigator, Minneapolis Heart Institute Foundation
All locations (6)
Minneapolis Heart Institute FoundationRecruiting
Minneapolis, Minnesota, United States
Sanger Heart and Vascular InstituteEnrolling By Invitation
Charlotte, North Carolina, United States
The Christ Hospital Health NetworkEnrolling By Invitation
Cincinnati, Ohio, United States
Cleveland ClinicEnrolling By Invitation
Cleveland, Ohio, United States
Inova Fairfax Medical CampusEnrolling By Invitation
Falls Church, Virginia, United States
IRCCS Ospedale San RaffaeleEnrolling By Invitation
Milan, Italy