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

Launched by BIO REFINE LTD. · Sep 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called the Bio Refine Coriofix System for patients with functional mitral regurgitation, which is a heart condition where the mitral valve does not close properly. This study is specifically for patients who are experiencing symptoms and are not eligible for traditional mitral valve surgery due to high risks. To participate, individuals must have been treated for heart failure and show specific symptoms, but they should not have other serious heart conditions or recent surgeries that might complicate their treatment.

If you or a loved one is eligible and decides to join the study, you will undergo the procedure and be monitored closely during and after it. The research team will follow up with you at the hospital and then again at 30 days, 6 months, and 12 months after the procedure to check on your health and how well the treatment is working. This study is currently looking for participants, and it aims to ensure that this new treatment is both safe and feasible for those who need it.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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