Bio Refine for Functional Mitral Regurgitation - a Safety & Feasibility Study
NCT ID: NCT06583876
Last Updated: 2025-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
15 participants
INTERVENTIONAL
2024-06-03
2027-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Coriofix treatment
Coriofix System
Treatment of functional mitral regurgitation by reducing the mitral valve annular area through ablation of the posterior annulus.
Interventions
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Coriofix System
Treatment of functional mitral regurgitation by reducing the mitral valve annular area through ablation of the posterior annulus.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Bio Refine Ltd.
INDUSTRY
Responsible Party
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Locations
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Gottsegen National Cardiovascular Center
Budapest, , Hungary
Rabin Medical Center
Petah Tikva, , Israel
Institute for Cardiovascular Diseases "Dedinje"
Belgrade, , Serbia
University Clinical Center Kragujevac
Kragujevac, , Serbia
Countries
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Central Contacts
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Facility Contacts
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Mihajlo Farkić, MD
Role: primary
Other Identifiers
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DMS-6470
Identifier Type: -
Identifier Source: org_study_id
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