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
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 (3+ or 4+)
- Adequately treated in compliance with optimal guideline-directed medical therapy for heart failure for at least 90 days
- NYHA functional class II, III or ambulatory IV
- Left ventricular ejection fraction (LVEF) �30%
- Written informed consent has been obtained
You will not qualify if you...
- Untreated clinically significant coronary artery disease requiring revascularization
- CABG, PCI or TAVR within the prior 90 days
- Aortic or tricuspid valve disease requiring surgery or transcatheter intervention or severe tricuspid regurgitation
- COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use
- Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within prior 180 days
- Hypotension
- Any history of ventricular arrhythmia
- Patients implanted with any kind of cardiac implantable electronic device (CIED)
- Life expectancy less than 12 months due to non-cardiac conditions
- Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure
- Transesophageal echocardiography (TEE) is contraindicated or high risk
- Pregnant or planning pregnancy within next 12 months
- Currently participating in an investigational drug or another device study that has not reached its primary endpoint
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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