MedTrace Logo

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

NCT06583876 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-03-27

No results posted yet for this 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.

Conditions

  • Functional Mitral Regurgitation

Interventions

DEVICE

Coriofix System

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

Sponsors & Collaborators

  • Bio Refine Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-03
Primary Completion
2026-01-31
Completion
2027-02-28

Countries

  • Hungary
  • Israel
  • Serbia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06583876 on ClinicalTrials.gov