The Study for Atrial Functional Mitral Regurgitation Response In Mitral Loop Cerclage Annuloplasty (AFRICA Study): Multi-center, Open Label, Single Arm, Feasibility Test
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1
- 试验地点
- 7
- 主要终点
- Change of mitral regurgitation severity(1)
研究概览
简要总结
To evaluate second stage 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 and Atrial Fibrillation mitral regurgitation Response in Mitral Loop Cerclage annuloplasty.
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, Functional Mitral Regurgitation 3+ (Moderate/Severe) or 4+ (Severe) 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)
- •and, Chronic Atrial Fibrillation in electrocardiography (Persistent AF or Permanent AF)
排除标准
- •Primary Mitral Regurgitation
- •LV ejection fraction lower than 30%
- •Pulmonary arterial pressure ≥ 60mmHg
- •End-diastolic Left ventricular dimension ≥ 70mm
- •Subjects with functional MR who need CABG or AVR performed
- •Pre-existing stent in a coronary artery that is deemed to be in direct contact with the path of mitral loop cerclage along coronary sinus
- •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
- •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 primary MR
- •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 do not have septal vein or have unsuitable septal vein anatomy by cardiac CT or venogram
- •Subjects who have thrombosis and embolism
- •Creatinine ≥2.0 mg/dL
- •Subjects who have coagulation disorders
- •Subjects who are unable to take anti-platelet agents
- •Pre-existing devices such as Implantable Cardioverter Defibrillator and Pacemaker
- •Subjects who are pregnant, or lactating, or plan pregnancy during the clinical trials
- •Subjects who are participated in other clinical trials within 1 month of enrollment
- •Subjects who are deemed not to be eligible in this study by physician's discretion
研究组 & 干预措施
Mitral Loop Cerclage
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
Change of mitral regurgitation severity(1)
时间窗: 1 month
changing regurgitant volume (RV,mL) compared with baseline
Change of mitral regurgitation severity(2)
时间窗: 1 month
changing effective regurgitant orifice (ERO,cm\^2) compared with baseline
Change in mitral annulus geometry
时间窗: 1 month
septal lateral dimension(mm)
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
次要结局
- Change in subjects' symptoms referred to NYHA Classification System(6 months)
- Change of mitral regurgitation severity(1)(6 months)
- Change of mitral regurgitation severity(2)(6 months)
- Change in mitral annulus geometry(6 months)
- Change in left ventricle volumes(6 months)
- Electrical remodeling(6 months)
- Technical success rate of the implantation(6 months)
- Rate of adverse events as a measure of safety(6 months)
研究者
Yong-Hyun Park,MD,PhD
Professor
Pusan National University Yangsan Hospital