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

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.

Study Overview

• Status: Recruiting
• Conditions: Functional Mitral Regurgitation
• Intervention / Treatment: Device: Coriofix System

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Boaz Shenhav; Phone Number: 972-52-561-1151; Email: boaz.s@bio-refine.com

Study Locations

• Hungary
  • Budapest, Hungary
    • Recruiting
    • Gottsegen National Cardiovascular Center
    • Contact: Géza Fontos, MD; Phone Number: +36 70 3820358; Email: geza.fontos@gmail.com
• Israel
  • Petah Tikva, Israel
    • Recruiting
    • Rabin Medical Center
    • Contact: Leor Perl, MD; Phone Number: +972-3-937-4666; Email: leorper@clalit.org.il
• Serbia
  • Belgrade, Serbia
    • Recruiting
    • Institute for Cardiovascular Diseases "Dedinje"
    • Contact: Mihajlo Farkić, MD; Phone Number: +381 11 3601 700
    • Contact: Mihajlo Farkić, MD
  • Kragujevac, Serbia
    • Recruiting
    • University Clinical Center Kragujevac
    • Contact: Miodrag Srećković, MD; Phone Number: +381 34 50 50 57; Email: sreckovic7@gmail.com
    • Contact: Miodrag Srećković, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coriofix treatment	Device: Coriofix System; Treatment of functional mitral regurgitation by reducing the mitral valve annular area through ablation of the posterior annulus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coriofix System Safety	Absence of Major Device- or Procedure-Related Serious Adverse Events	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coriofix System Safety	Absence of Major Device- or Procedure-Related Serious Adverse Events	6 and 12 months
Device technical success	Successful system operation with no related emergency surgery or reintervention	Procedure
Treatment success	Change of MR grade	30 days

Collaborators and Investigators

• Sponsor: Bio Refine Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: September 2, 2024
• First Submitted That Met QC Criteria: September 2, 2024
• First Posted (Actual): September 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: DMS-6470

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No