Bio Refine for Functional Mitral Regurgitation - a Safety & Feasibility Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Coriofix System.
- Who it may be relevant to
- Registry conditions: Functional Mitral Regurgitation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hungary, Israel, Serbia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Coriofix System
Treatment of functional mitral regurgitation by reducing the mitral valve annular area through ablation of the posterior annulus.
Primary outcome measures
- Coriofix System Safety [Time frame: 30 days]
Secondary outcome measures (3)
- Coriofix System Safety [Time frame: 6 and 12 months]
- Device technical success [Time frame: Procedure]
- Treatment success [Time frame: 30 days]
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
- NYHA functional class II, III or ambulatory IV
- LVEF ≥30%.
- Written informed consent has been obtained
Exclusion criteria
- 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.
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Serbia · 2 centers
- Institute for Cardiovascular Diseases "Dedinje" — Belgrade
- University Clinical Center Kragujevac — Kragujevac
Hungary · 1 center
- Gottsegen National Cardiovascular Center — Budapest
Israel · 1 center
- Rabin Medical Center — Petah Tikva
Identifiers
NCT: NCT06583876 · DMS-6470