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RECRUITING
NCT06583876
NA

Bio Refine for Functional Mitral Regurgitation - a Safety & Feasibility Study

Sponsor: Bio Refine Ltd.

View on ClinicalTrials.gov

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

Interventions

DEVICE

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