Evaluating a new system for treating functional mitral regurgitation

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

This study is testing a new treatment system for people with functional mitral regurgitation who can't have regular surgery to see if it is safe and effective.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Bio Refine Ltd. (Industry-sponsored)
• Locations: 4 sites (Budapest and 3 other locations)
• Trial ID: NCT06583876 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and feasibility of the Bio Refine Coriofix System for patients suffering from functional mitral regurgitation who are not candidates for traditional mitral valve surgery. It will include patients with symptomatic secondary mitral regurgitation who have been adequately treated with guideline-directed medical therapy for heart failure. Participants will undergo the procedure and will be monitored during the hospital stay, with follow-up assessments scheduled at 30 days, 6 months, and 12 months post-procedure to evaluate outcomes.

Who should consider this trial

Good fit: Ideal candidates are patients with symptomatic secondary mitral regurgitation who are not eligible for mitral valve surgery due to prohibitive risks.

Not a fit: Patients with untreated significant coronary artery disease or those requiring other cardiac interventions will likely not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option for patients with severe mitral regurgitation who currently have limited alternatives.

How similar studies have performed: While this approach is novel, similar interventions in the field of mitral valve treatment have shown promise, indicating potential for success.

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

Where this trial is running

Budapest and 3 other locations

• Gottsegen National Cardiovascular Center — Budapest, Hungary (Recruiting)
• Rabin Medical Center — Petah Tikva, Israel (Recruiting)
• Institute for Cardiovascular Diseases "Dedinje" — Belgrade, Serbia (Recruiting)
• University Clinical Center Kragujevac — Kragujevac, Serbia (Recruiting)

Study contacts

• Study coordinator: Boaz Shenhav

Conditions Functional Mitral Regurgitation