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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-03

Study Completion Date

2027-07-31

Brief Summary

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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

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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).

Conditions

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Heart Failure and Reduced Ejection Fraction Functional Mitral Regurgitation

Keywords

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heart failure reduced ejection fraction functional mitral regurgitation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1 group undergoing guideline directed TEER with FDA approved MitraClip

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.

Cardiac MRI

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Transthoracic echocardiogram

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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João Cavalcante, MD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis Heart Institute Foundation

Locations

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Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Site Status RECRUITING