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

NCT07131631 | Recruiting

• 1 other identifier: 1807968
• Study Type: observational
• Target: 125
• Locations: 2 countries
• Sites: 6

Brief Summary

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.

Conditions

Functional Mitral Regurgitation; Heart Failure and Reduced Ejection Fraction

Keywords

heart failure; reduced ejection fraction; functional mitral regurgitation

Outcome Measures

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

  From enrollment to the end of 6 months

Secondary Outcomes (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;

  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

  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

  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;

  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

  Enrollment to the end of 6 months

Study Arms (1)

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.

Diagnostic Test: Cardiac MRI

Interventions

Cardiac MRI 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.

Also known as: Transthoracic echocardiogram

1 group undergoing guideline directed TEER with FDA approved MitraClip

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing guideline-directed TEER with FDA-approved MitraClip at the participating centers will be screened and recruited for study participation.

You may qualify if:

• \. 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Minneapolis Heart Institute Foundation: lead

Study Sites (6)

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

RECRUITING

Sanger Heart and Vascular Institute

Charlotte, North Carolina, 28204, United States

ENROLLING BY INVITATION

The Christ Hospital Health Network

Cincinnati, Ohio, 45219, United States

ENROLLING BY INVITATION

Cleveland Clinic

Cleveland, Ohio, 44195, United States

ENROLLING BY INVITATION

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042, United States

ENROLLING BY INVITATION

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

ENROLLING BY INVITATION

MeSH Terms

Conditions

Heart Failure, Systolic; Heart Failure

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• João Cavalcante, MD

  Minneapolis Heart Institute Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

João Cavalcante, MD

CONTACT

612-863-3900; joao.cavalcante@allina.com

Sarah Schwager, RN

CONTACT

612-863-6257; sarah.schwager@allina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 20, 2025
• Study Start: March 3, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (5); IT (1)