Bio Refine for Functional Mitral Regurgitation - a Safety & Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 15
- Locations
- 4
- Primary Endpoint
- Coriofix System Safety
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Coriofix treatment
Intervention: Coriofix System (Device)
Outcomes
Primary Outcomes
Coriofix System Safety
Time Frame: 30 days
Absence of Major Device- or Procedure-Related Serious Adverse Events
Secondary Outcomes
- Coriofix System Safety(6 and 12 months)
- Device technical success(Procedure)
- Treatment success(30 days)