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

Recruiting N/A Interventional Study
Functional Mitral Regurgitation
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
15 (estimated)
Sponsor
Bio Refine Ltd. · Industry
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About This Trial
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 scr…
Trial Locations
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Eligibility Criteria
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…
Contacts

Boaz Shenhav

972-52-561-1151

boaz.s@bio-refine.com

CONTACT