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Effect of MitraClip on Acute and Chronic Reverse Cardiac Remodeling Assessed by CMR: The MITRA-REVERSE Study
Sponsor: Dipan Shah
Summary
The purpose of this study is to use cardiac magnetic resonance (CMR) and echocardiography to define the anatomic and functional remodeling that results from MitraClip implantation. A total of sixty (60) patients undergoing MitraClip implantation will be enrolled across multiple sites. The severity of mitral regurgitation, cardiac morphology and function will be assessed in these patients by taking cardiac magnetic resonance imaging with an FDA approved contrast agent at BASELINE (within 30 days prior to MitraClip implantation), during the ACUTE REMODELING PHASE (pre-discharge following implantation), and during the CHRONIC REMODELING PHASE (6 months post-implantation).
Official title: Effect of MitraClip on Reverse Cardiac Remodeling Assessed by CMR and Echocardiography: The MITRA-REVERSE Study A Prospective Multicenter Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
54
Start Date
2017-01
Completion Date
2021-12
Last Updated
2026-04-20
Healthy Volunteers
No
Conditions
Interventions
Cardiac MRI with or without contrast dye
MRI scans of the heart are performed before and after the MitraClip clinical procedure with an FDA cleared device with or without an FDA approved contrast dye.
Blood sample
Blood samples collected to calculate hematocrit for measurements of the CMR extracellular matrix.
Locations (2)
Piedmont Heart Institute
Atlanta, Georgia, United States
Houston Methodist Hospital
Houston, Texas, United States