Status:
RECRUITING
Bio Refine for Functional Mitral Regurgitation - a Safety & Feasibility Study
Lead Sponsor:
Bio Refine Ltd.
Conditions:
Functional Mitral Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 in...
Eligibility Criteria
Inclusion
- 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
- LVEF ≥30%.
- Written informed consent has been obtained
Exclusion
- 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.
- CVA or TIA within prior 180 days.
- Hypotension
- Any history of ventricular arrythmia
- Patients implanted with any kind of CIED
- Life expectancy \<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
- 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
Key Trial Info
Start Date :
June 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06583876
Start Date
June 3 2024
End Date
February 1 2027
Last Update
March 27 2025
Active Locations (4)
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1
Gottsegen National Cardiovascular Center
Budapest, Hungary
2
Rabin Medical Center
Petah Tikva, Israel
3
Institute for Cardiovascular Diseases "Dedinje"
Belgrade, Serbia
4
University Clinical Center Kragujevac
Kragujevac, Serbia