The Study on Safety and Feasibility of Mitral Loop Cerclage(MLC) Annuloplasty Procedure With Investigational Medical Device (MLC-B-45-75-R and Other 11 Models) : Single-centre, Open Label, Single Arm, Feasibility Test
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 4
- 主要终点
- Rate of adverse events as a measure of safety
研究概览
简要总结
To evaluate safety and feasibility of Mitral Loop Cerclage(MLC) Annuloplasty with CSTV for repair of functional mitral regurgitation.
详细描述
The objective of this prospective, single-center, open label, feasibility test is to assess the safety and efficacy of Mitral Loop Cerclage Annuloplasty with CSTV protective device in treating functional mitral regurgitation (FMR) associated with heart failure.
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
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NYHA(New York Heart Association) Class III - IV, and symptomatic severe functional MR by 2014 ACC/AHA guideline in spite of optimal medical treatment.
- •(For optimal medical treatments, ①ACE inhibitor or angiotensin receptor blocker ②β-blocker ③ aldosterone antagonists should be given for at least 3 months unless the subject has contraindication for each drug)
排除标准
- •Primary Mitral Regurgitation
- •LV ejection fraction lower than 25%
- •Creatinine ≥2.0 mg/dL
- •Anomaly of Coronary Sinus
- •Pre-existing devices in coronary sinus such as Implantable Cardioverter Defibrillator and Pacemaker
- •2:1 Atriventricular AV block or higher AV block and ventricular tachycardia
- •Subjects with functional MR who need CABG or AVR performed
- •Subjects who have functional MR caused by aortic valve disease
- •Subjects who have uncontrollable hyperthyroidism
- •Subjects who have severe TR due to primary valve leaflet disease
- •Subjects who cannot be screened by cardiac CT
- •Subjects who have possibility of coronary artery pinching even with Mitral Loop Cerclage system judged by cardiac CT
- •Subjects who are unable to take anti-platelet agents
- •Subjects who are participated in other clinical trials within 1 month of enrollment
- •Subjects who have coagulation disorders
- •Subjects who have thrombosis and embolism
- •Subjects who are pregnant, or lactating, or plan pregnancy during the clinical trials
- •Subjects who are deemed not to be eligible in this study by physician's discretion
研究组 & 干预措施
Single
Intervention: Device: Mitral Loop Cerclage Annuloplasty with CSTV Protective Device
干预措施: Mitral Loop Cerclage Annuloplasty (Device)
结局指标
主要结局
Rate of adverse events as a measure of safety
时间窗: 1 month
Rate of composite endpoint of MACE (Major Adverse Cardiac Event) \* Death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke
Change of mitral regurgitation severity by regurgitant volume (RV) and effective regurgitant orifice (ERO)
时间窗: 1 month
Change in mitral annulus geometry (septal lateral dimension)
时间窗: 1 month
次要结局
- Technical success rate of the implantation and technical feasibility(6 months)
- Change of mitral regurgitation severity by regurgitant volume (RV) and effective regurgitant orifice (ERO)(6 months)
- Change in mitral annulus geometry (septal lateral dimension)(6 months)
- Change in mitral valve hemodynamics(6 months)
- Change in left ventricle volumes(6 months)
- Change in subjects' symptoms referred to NYHA (New York Heart Association) Classification System(6 months)
- Rate of adverse events as a measure of safety(6 months)
研究者
June-Hong Kim, MD, PhD
Professor
Pusan National University Yangsan Hospital