Secondary Mitral Regurgitation Treatment With MitraClip and Assessment by Cardiac Magnetic Resonance
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cardiac MRI.
- Who it may be relevant to
- Registry conditions: Heart Failure and Reduced Ejection Fraction, Functional Mitral Regurgitation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Detailed description
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).
Interventions
- Diagnostic test Cardiac MRI
Clinically indicated baseline CMR study with contrast up to 90 days before TEER procedure, including KCCQ questionnaire. At 6 months, participants will return for repeat of KCCQ, CMR study and a transthoracic echocardiogram. Blood samples, done as standard clinical care for hemotocrit for ECV calculation, will be obtained.
Primary outcome measures
- Estimate the association between LV myocardial fibrosis by CMR late gadolinium enhancement imaging before TEER with LV reverse remodeling. [Time frame: From enrollment to the end of 6 months]
Secondary outcome measures (6)
- Estimate the association of the ratio between CMR-based mitral regurgitant volume (RegVol) and LV end-diastolic volume (LVEDV)-RegVol/LVEDV-with LV reverse remodeling; [Time frame: Enrollment to the end of 6 months]
- Evaluate the interaction between CMR-based mitral regurgitation quantification (RegVol and regurgitant fraction) with LV myocardial fibrosis extent, and its association with LV reverse remodeling [Time frame: Enrollment to the end of 6 months]
- Estimate the association between LV extracellular volume (ECV) by CMR T1 mapping before TEER with LV reverse remodeling [Time frame: Enrollment to the end of 6 months]
- Estimate the association of LV myocardial fibrosis extent and a combined endpoint including all-cause death, heart failure hospitalization, cardiac transplant and LVAD implant; [Time frame: Enrollment to the end of 6 months]
- Estimate the association of LV myocardial fibrosis extent and the change in quality-of-life (Kansas City Cardiomyopathy Questionnaire [KCCQ]) post TEER [Time frame: Enrollment to the end of 6 months]
- Estimate the intermodality agreement of residual MR between 3D echo and CMR at 6 months post-TEER [Time frame: Enrollment through 6 months]
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
- Concomitant PCI and TEER
- Congenital heart disease
- Stage D heart failure
- Uncontrolled atrial fibrillation
- Pregnancy
- > moderate tricuspid regurgitation
- >moderate aortic regurgitation or stenosis
- Contraindications or unable to undergo CMR
- Prior mitral valve repair or replacement
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 5 centers
- Minneapolis Heart Institute Foundation — Minneapolis
- Sanger Heart and Vascular Institute — Charlotte
- The Christ Hospital Health Network — Cincinnati
- Cleveland Clinic — Cleveland
- Inova Fairfax Medical Campus — Falls Church
Italy · 1 center
- IRCCS Ospedale San Raffaele — Milan
Identifiers
NCT: NCT07131631 · 1807968