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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Hungary
Gottsegen National Cardiovascular Center
RECRUITING
Budapest
Israel
Rabin Medical Center
RECRUITING
Petah Tikva
Serbia
Institute for Cardiovascular Diseases Dedinje
RECRUITING
Belgrade
University Clinical Center Kragujevac
RECRUITING
Kragujevac
Contact Information
Primary
Boaz Shenhav
boaz.s@bio-refine.com
972-52-561-1151
Time Frame
Start Date: 2024-06-03
Estimated Completion Date: 2027-02
Participants
Target number of participants: 15
Treatments
Experimental: Coriofix treatment
Related Therapeutic Areas
Sponsors
Leads: Bio Refine Ltd.

This content was sourced from clinicaltrials.gov