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RECRUITING
NCT07131631

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

Sponsor: Minneapolis Heart Institute Foundation

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

125

Start Date

2022-03-03

Completion Date

2027-07

Last Updated

2025-12-23

Healthy Volunteers

No

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.

Locations (6)

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Sanger Heart and Vascular Institute

Charlotte, North Carolina, United States

The Christ Hospital Health Network

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Inova Fairfax Medical Campus

Falls Church, Virginia, United States

IRCCS Ospedale San Raffaele

Milan, Italy