Bio Refine for Functional Mitral Regurgitation - a Safety & Feasibility Study
ConditionFunctional Mitral Regurgitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBio Refine Ltd.
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 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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Coriofix System
DeviceTreatment of functional mitral regurgitation by reducing the mitral valve annular area through ablation of the posterior annulus.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Coriofix treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Coriofix System Safety
Absence of Major Device- or Procedure-Related Serious Adverse Events
Time frame
30 daysSecondary outcomes
1
Coriofix System Safety
Absence of Major Device- or Procedure-Related Serious Adverse Events
Time frame
6 and 12 months2
Device technical success
Successful system operation with no related emergency surgery or reintervention
Time frame
Procedure3
Treatment success
Change of MR grade
Time frame
30 daysSponsors and contacts
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Source ClinicalTrials.gov