Actively Recruiting
Bio Refine for Functional Mitral Regurgitation - a Safety & Feasibility Study
Led by Bio Refine Ltd. · Updated on 2025-03-27
15
Participants Needed
4
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of the Bio Refine Coriofix System in treating functional mitral regurgitation, a heart valve condition where the mitral valve does not close properly. This study focuses on patients with symptomatic secondary mitral regurgitation who cannot or will not undergo mitral valve surgery due to high risk. The trial aims to determine if the Coriofix System might offer a treatment option for these patients. The Coriofix System is a device designed to reduce the mitral valve annular area through ablation of the posterior annulus, potentially improving valve function. Participants will receive this treatment during the procedure, and all enrolled patients who undergo the procedure will be followed up closely. Follow-up assessments are planned at hospital discharge, 30 days, 6 months, and 12 months after the procedure to monitor safety and treatment success. Participants will be monitored for safety during the procedure and throughout the follow-up periods. Researchers will evaluate device technical success, treatment success at 30 days, and safety at 30 days as primary outcomes, with additional safety assessments at 6 and 12 months. The total involvement includes the initial treatment and post-procedure follow-up visits extending up to one year to assess ongoing safety and feasibility of the device.
CONDITIONS
Brief Title
Bio Refine for Functional Mitral Regurgitation - a Safety & Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Local heart team has determined that mitral valve surgery will not be offered as a treatment option
- Symptomatic secondary mitral regurgitation graded 3+ or 4+
- Received optimal guideline-directed medical therapy for heart failure for at least 90 days
- New York Heart Association (NYHA) functional class II, III, or ambulatory IV
- Left ventricular ejection fraction (LVEF) of 30% or higher
- Written informed consent obtained
You will not qualify if you...
- Untreated clinically significant coronary artery disease requiring revascularization
- Coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), or transcatheter aortic valve replacement (TAVR) within prior 90 days
- Aortic or tricuspid valve disease requiring surgery or transcatheter intervention or severe tricuspid regurgitation
- Chronic obstructive pulmonary disease (COPD) requiring continuous home oxygen or chronic outpatient oral steroid use
- Stroke or transient ischemic attack (TIA) within prior 180 days
- Hypotension
- Any history of ventricular arrhythmia
- Presence of any implanted cardiac implantable electronic device (CIED)
- Life expectancy under 12 months due to non-cardiac conditions
- Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve or prior transcatheter mitral valve procedure
- Contraindication or high risk for transesophageal echocardiography (TEE)
- Pregnancy or planning pregnancy within next 12 months
- Current participation in another investigational drug or device study that has not reached its primary endpoint
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 - Procedure day
Participants receive treatment with the Coriofix System to reduce the mitral valve annular area through ablation of the posterior annulus.
1 visit (in-person)
Duration - Up to 12 months
Participants are monitored for safety and treatment success after the procedure.
Visits at 30 days, 6 months, and 12 months (in-person)
Trial Site Locations
Total: 4 locations
1
Gottsegen National Cardiovascular Center
Budapest, Hungary
Actively Recruiting
2
Rabin Medical Center
Petah Tikva, Israel
Actively Recruiting
3
Institute for Cardiovascular Diseases "Dedinje"
Belgrade, Serbia
Actively Recruiting
4
University Clinical Center Kragujevac
Kragujevac, Serbia
Actively Recruiting
Research Team
B
Boaz Shenhav
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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