Bio Refine for Functional Mitral Regurgitation - a Safety & Feasibility Study
Condition(s) studied
Investigational drug(s) / intervention(s)
Coriofix System: Treatment of functional mitral regurgitation by reducing the mitral valve annular area through ablation of the posterior annulus.
Study 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 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.
Eligibility
Primary outcome measure(s)
- Coriofix System Safety — 30 days
Absence of Major Device- or Procedure-Related Serious Adverse Events
Trial sites (8)
| Facility | City | Region | Status |
|---|---|---|---|
| Gottsegen National Cardiovascular Center | Budapest | Hungary | Recruiting |
| University of Debrecen | Debrecen | Hungary | Recruiting |
| Rabin Medical Center | Petah Tikva | Israel | Recruiting |
| Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach | Katowice | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny w Poznaniu | Poznan | Poland | Recruiting |
| Wojskowy Instytut Medyczny | Warsaw | Poland | Not Yet Recruiting |
| Institute for Cardiovascular Diseases "Dedinje" | Belgrade | Serbia | Terminated |
| University Clinical Center Kragujevac | Kragujevac | Serbia | Withdrawn |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06583876 on ClinicalTrials.gov ↗ ← All trials in Poland