Secondary Mitral Regurgitation Treatment With MitraClip and Assessment by Cardiac Magnetic Resonance (SMARTER-CMR)

Minneapolis Heart Institute Foundation

Status: Enrolling

Conditions: Functional Mitral Regurgitation; Heart Failure and Reduced Ejection Fraction

Treatments: Diagnostic Test: Cardiac MRI

Study type: Observational

Funder types: Other

Identifiers

NCT07131631

1807968

Details and patient eligibility

About

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.

Full 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).

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

125 participants in 1 patient group

1 group undergoing guideline directed TEER with FDA approved MitraClip

Description:

Cohort will undergo a clinically indicated baseline CMR study with contrast up to 90 days before TEER procedure. Quality of life questionnaire will also be completed. At 6 months, individuals will return to the clinic to repeat quality of life questionnaires, the CMR study and a transthoracic echocardiogram.

Treatment:

Diagnostic Test: Cardiac MRI