NCT06583876

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Bio Refine Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Functional Mitral Regurgitation

Interventions

Type	Name	Description
DEVICE	Coriofix System	Treatment of functional mitral regurgitation by reducing the mitral valve annular area through ablation of the posterior annulus.

Timeline

• Start date: 2024-06-03
• Primary completion: 2026-01-01
• Completion: 2027-02-01
• First posted: 2024-09-04
• Last updated: 2025-03-27

Locations

4 sites across 3 countries: Hungary, Israel, Serbia