Actively Recruiting
Secondary Mitral Regurgitation Treatment With MitraClip and Assessment by Cardiac Magnetic Resonance
Led by Minneapolis Heart Institute Foundation · Updated on 2025-12-23
125
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study patients with heart failure and reduced ejection fraction who have significant functional mitral regurgitation and are undergoing treatment with the FDA-approved MitraClip device. The goal is to understand how the amount of left ventricular (LV) heart muscle scarring, assessed by cardiac magnetic resonance imaging (CMR), affects heart recovery and clinical outcomes after the treatment. This observational study plans to enroll up to 125 patients across multiple centers to obtain data from 100 patients after six months of follow-up. Participants will have a baseline CMR scan with contrast and complete a quality-of-life questionnaire up to 90 days before their transcatheter edge-to-edge repair (TEER) procedure using MitraClip. Six months after TEER, patients will return to repeat the quality-of-life questionnaire, CMR scan, and an echocardiogram, ideally on the same day or within 30 days. Blood samples will be taken on the CMR day for hematocrit measurement as part of routine care. During the study, researchers will collect clinical data from electronic health records and make yearly phone contacts for up to three years to monitor outcomes such as heart failure hospitalizations, use of intravenous medications, heart device implantation, heart transplant, or death. The main measure is the relationship between LV scarring before TEER and heart recovery six months later. Secondary measures include associations with mitral regurgitation severity, quality of life changes, and agreement between imaging methods.
CONDITIONS
Brief Title
Secondary Mitral Regurgitation Treatment With MitraClip and Assessment by Cardiac Magnetic Resonance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients 18 years or older
- Heart failure with reduced ejection fraction (less than 50% by echocardiography)
- Medically and device-optimized according to guidelines
- Significant functional mitral regurgitation
- Undergoing transcatheter edge-to-edge repair (TEER) with FDA-approved MitraClip device
You will not qualify if you...
- Undergoing percutaneous coronary intervention (PCI) at the same time as TEER
- Presence of congenital heart disease
- Stage D heart failure
- Uncontrolled atrial fibrillation
- Pregnant women
- More than moderate tricuspid regurgitation
- More than moderate aortic regurgitation or stenosis
- Contraindications or inability to undergo cardiac magnetic resonance imaging (CMR)
- Prior mitral valve repair or replacement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 90 days before MitraClip procedure
Participants undergo a clinically indicated baseline cardiac magnetic resonance (CMR) study with contrast and complete a quality-of-life questionnaire up to 90 days before the MitraClip procedure.
1 visit (in-person)
Duration - Day of MitraClip procedure
Participants undergo transcatheter edge-to-edge repair (TEER) with the FDA-approved MitraClip device as part of routine care.
1 day procedure visit
Duration - 6 months after MitraClip procedure
Six months after the MitraClip procedure, participants return to repeat the quality-of-life questionnaire, CMR study, and transthoracic echocardiogram. Blood samples are collected on the day of the CMR for hematocrit calculation as part of standard care.
1 visit (in-person) or 2 visits within 30 days
Duration - Up to 3 years after MitraClip procedure
Participants are followed yearly for up to three years after the MitraClip procedure through electronic health record review and phone contact to evaluate clinical outcomes.
Annual phone contact and record review
Trial Site Locations
Total: 6 locations
1
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
2
Sanger Heart and Vascular Institute
Charlotte, North Carolina, United States, 28204
Enrolling by Invitation
3
The Christ Hospital Health Network
Cincinnati, Ohio, United States, 45219
Enrolling by Invitation
4
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Enrolling by Invitation
5
Inova Fairfax Medical Campus
Falls Church, Virginia, United States, 22042
Enrolling by Invitation
6
IRCCS Ospedale San Raffaele
Milan, Italy, 20132
Enrolling by Invitation
Research Team
J
João Cavalcante, MD
S
Sarah Schwager, RN
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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