Bio Refine for Functional Mitral Regurgitation - a Safety & Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Coriofix System Safety
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Coriofix System Safety
时间窗: 30 days
Absence of Major Device- or Procedure-Related Serious Adverse Events
次要结局
- Coriofix System Safety(6 and 12 months)
- Device technical success(Procedure)
- Treatment success(30 days)