Evaluating a new system for treating functional mitral regurgitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Boaz Shenhav
• Email: boaz.s@bio-refine.com
• Phone: 972-52-561-1151

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• MitraClip for secondary (functional) mitral regurgitation with cardiac MRI scar measurement

  The study will try to see if the amount of scar (fibrosis) seen on cardiac MRI predicts left‑ventricular recovery and clinical outcomes after MitraClip in people with heart failure and reduced ejection fraction.

  Recruiting Minneapolis Heart Institute Foundation · Minneapolis, Minnesota and 5 other locations · NCT07131631

• Evaluating a new system for treating functional mitral regurgitation

  This study is testing a new device to see if it can safely help people with moderate to severe mitral regurgitation feel better when other treatments haven't worked.

  Recruiting Shanghai Shenqi Medical Technology Co., Ltd · Valladolid, Valladolid · NCT06823700

• Personalized risk prediction for functional mitral regurgitation using cardiac imaging

  This study is testing if advanced heart imaging can help predict how well patients with functional mitral regurgitation will respond to treatment.

  Recruiting The Cleveland Clinic · Cleveland, Ohio · NCT05965258

• Understanding valve disease in patients with atrial fibrillation

  This study is trying to understand different types of valve problems in people with atrial fibrillation to see how they affect health and what might make them worse over time.

  Recruiting Barts & The London NHS Trust · London · NCT05920824

• Using the Carillon Mitral Contour System to treat heart failure with mild functional mitral regurgitation

  This study is testing if the Carillon Mitral Contour System can help people with heart failure and mild mitral regurgitation feel better compared to a similar procedure without the device.

  Recruiting at 61 sites Cardiac Dimensions Pty Ltd · Gilbert, Arizona and 91 other locations · NCT03142152

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.