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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Minneapolis Heart Institute Foundation
Study ID
NCT07131631
Status
Recruiting
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Conditions

  • Functional Mitral Regurgitation
  • Heart Failure and Reduced Ejection Fraction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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 Dates

Start date
Mar 3, 2022
Status verified
Aug 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
125 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Estimate the association between LV myocardial fibrosis by CMR late gadolinium enhancement imaging before TEER with LV reverse remodeling. [ Time Frame: From enrollment to the end of 6 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Minneapolis Heart Institute FoundationMinneapolisMinnesota55407
Sarah Schwager, RN
[email protected]
João Cavalcante, MD (PRINCIPAL_INVESTIGATOR)
Sanger Heart and Vascular InstituteCharlotteNorth Carolina28204-
The Christ Hospital Health NetworkCincinnatiOhio45219-
Cleveland ClinicClevelandOhio44195-
Inova Fairfax Medical CampusFalls ChurchVirginia22042-

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Minneapolis Heart Institute Foundation· Minneapolis, MNSanger Heart and Vascular Institute· Charlotte, NCThe Christ Hospital Health Network· Cincinnati, OHCleveland Clinic· Cleveland, OHInova Fairfax Medical Campus· Falls Church, VA

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