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

NCT06583876 | Recruiting

• 1 other identifier: DMS-6470
• Study Type: interventional
• Target: 15
• Locations: 3 countries
• Sites: 4

Brief 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.

Conditions

Functional Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

• Coriofix System Safety

  Absence of Major Device- or Procedure-Related Serious Adverse Events

  30 days

Secondary Outcomes (3)

• Coriofix System Safety

  6 and 12 months

• Device technical success

  Procedure

• Treatment success

  30 days

Study Arms (1)

Coriofix treatment

EXPERIMENTAL

Device: Coriofix System

Interventions

Coriofix System DEVICE

Treatment of functional mitral regurgitation by reducing the mitral valve annular area through ablation of the posterior annulus.

Coriofix treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bio Refine Ltd.: lead

Study Sites (4)

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

Central Study Contacts

Boaz Shenhav

CONTACT

972-52-561-1151; boaz.s@bio-refine.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 4, 2024
• Study Start: June 3, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 27, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1); SE (2); IL (1)