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Bio Refine for Functional Mitral Regurgitation - a Safety & Feasibility Study
Sponsor: Bio Refine Ltd.
Summary
The purpose of this study is to evaluate the safety and feasibility of the Bio Refine Coriofix System and determine if it might help in treatment of functional mitral regurgitation. The study will include patients with symptomatic secondary mitral regurgitation in whom mitral surgery cannot and/or will not be offered as a treatment option (the risk is prohibitive). Potential patients will be screened to confirm that all inclusion/exclusion criteria are met, with final eligibility confirmation on day of procedure. All enrolled subjects who went through the procedure will be followed during the procedure to hospital discharge. Additional follow up time points are scheduled at 30 days, 6 months and 12 months post procedure.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2024-06-03
Completion Date
2027-02
Last Updated
2025-03-27
Healthy Volunteers
No
Conditions
Interventions
Coriofix System
Treatment of functional mitral regurgitation by reducing the mitral valve annular area through ablation of the posterior annulus.
Locations (4)
Gottsegen National Cardiovascular Center
Budapest, Hungary
Rabin Medical Center
Petah Tikva, Israel
Institute for Cardiovascular Diseases "Dedinje"
Belgrade, Serbia
University Clinical Center Kragujevac
Kragujevac, Serbia