Ireland
--:--IST
Recruiting Not applicable

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

NCT06583876 · tracked via the Priya Life Science Poland tracker
Sponsor
Bio Refine Ltd
Phase
Not applicable
Started
2024-06-03
Last updated
2026-10-02

Condition(s) studied

Functional Mitral Regurgitation

Investigational drug(s) / intervention(s)

Coriofix System

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Coriofix System Safety — 30 days
    Absence of Major Device- or Procedure-Related Serious Adverse Events

Trial sites (8)

FacilityCityRegionStatus
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
Official registry record

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