Secondary Mitral Regurgitation Treatment With MitraClip and Assessment by Cardiac Magnetic Resonance
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMinneapolis Heart Institute Foundation
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Concomitant PCI and TEER
Congenital heart disease
Stage D heart failure
Uncontrolled atrial fibrillation
Trial population
Patients undergoing guideline-directed TEER with FDA-approved MitraClip at the participating centers will be screened and recruited for study participation.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Cardiac MRI
Diagnostic testClinically 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.
Treatment groups
125 Participants
are divided into 1 treatment groupGroup A: 1 group undergoing guideline directed TEER with FDA approved MitraClip1 intervention
Trial outcomes
Primary outcomes
1
Estimate the association between LV myocardial fibrosis by CMR late gadolinium enhancement imaging before TEER with LV reverse remodeling.
change in LV end-diastolic volume index \[LVEDVi\] 6 months after TEER
Time frame
From enrollment to the end of 6 monthsSecondary outcomes
1
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;
Reg/Vol and LVEDV with LV reverse remodeling
Time frame
Enrollment to the end of 6 months2
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
RegVol and regurgitant fraction with LV myocardial fibrosis extent
Time frame
Enrollment to the end of 6 months3
Estimate the association between LV extracellular volume (ECV) by CMR T1 mapping before TEER with LV reverse remodeling
ECV before TEER with LV reverse remodeling
Time frame
Enrollment to the end of 6 months4
Estimate the association of LV myocardial fibrosis extent and a combined endpoint including all-cause death, heart failure hospitalization, cardiac transplant and LVAD implant;
LV myocardial fibrosis and endpoint data points (all cause death, heart failure hospitalization, cardiac transplant and LVAD implant)
Time frame
Enrollment to the end of 6 monthsSponsors and contacts
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Source ClinicalTrials.gov