Efficacy And Safty of Heartech® Left Ventricular Partitioning Device In Treating Heart Failure Post Myocardial Infarction (Phase II Clinical Trial: The Partical Study)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Incidence of MACCE [primary safety]
研究概览
简要总结
This is a prospective, multi-center, single-group, target-value clinical study. The primary safety end points are major adverse cardiovascular events (MACCE) 30 days after device implantation.
The primary efficacy end point is the end of left ventricular systolic volume index (LVESVI) reduction at 6 month.
The secondary observational end points includes immediate success rate of the procedure, all-cause mortality, cardiac death, rehospitalization rates and MACCE occurrence rate within 12 month. Besides, left ventricular end systolic volume index (LVESVI) change at 30 days,12 months, left ventricular ejection fraction (LVEF), left ventricular end-diastolic volume index (LVEDVI), 6 minutes walk test, heart function evaluation (NYHA classification) and quality of life (EQ-5D) at 30 days, 6 months, 12 months will also be evaluated.
After statistical hypothesis and sample size estimation, the sample size of this clinical trial was 117 cases. All subjects were followed up 30 days, 6 months and 12 months after implantation of the Heartech® left ventricular partitioning device. All relevant clinical data were managed by professional data management center, and all relevant clinical data were statistically analyzed by third-party statistical center.
详细描述
MACCE includes all-cause death, myocardial infarction, stroke and any elective or emergency cardiac or thoracic aortic surgery or catheter-based interventional therapy.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •left ventricular ejection fraction ≤45% and ≥20%;
- •patients with left ventricular end-systolic volume index (ESVI) ≥50mL/m2;
- •transthoracic ultrasound showed contradictory motion of the left ventricle after myocardial infarction;
- •60 days prior to anterior wall myocardial infarction with ischemic heart failure (NYHA grade II to "not hospitalized" grade IV);
- •the left ventricle must have the appropriate anatomic structure (size and shape) which is confirmed by cardiac CT and left ventricular angiography to implant the appropriate Heartech® device;
- •agree to receive reasonable treatment according to current ACC/AHA and Chinese guidelines for heart failure diagnosis and treatment;
- •the subjects or their legal representatives are informed of the nature of this study and agree to participate in all the terms of this study, sign the informed consent approved by the ethics committee, agree to accept the postoperative treatment plan and follow-up requirements, and can complete the examination of follow-up.
排除标准
- •patients whose left ventricular anatomy is not suitable for Heartech® occlusal device implantation;
- •the abnormal ventricular wall movement not contains the anterior wall of the left ventricle, the apex of the left ventricle and the ventricular septum;
- •patients with thrombosis in the left ventricle;
- •mitral stenosis or regurgitation (tricuspid, aortic or mitral) > 2+ (moderate);
- •recent (within 6 month) cerebrovascular accident (CVA) or transient ischemic attack (TIA);
- •end-stage renal disease requiring long-term dialysis, episodic sepsis or active phase endocarditis;
- •life expectancy at admission < 1 year;
- •known allergy to aspirin, heparin, warfarin, Nitinol (alloys of titanium and nickel) or contraindications, or sensitivity to contrast agents;
- •cardiogenic shock occurred within 72 hours before procedure;
- •pregnancy or planned pregnancy during the study period;
- •participated in clinical trials of other drugs or medical devices during the same period;
- •the researcher judged that the patient had poor compliance and could not complete the study as required;
- •other conditions considered unsuitable for participation in this clinical trial.
研究组 & 干预措施
PVR implantation group
Patients enrolled receive PVR intervention
干预措施: percutaneous ventricular restoration using heartech® device (Device)
结局指标
主要结局
Incidence of MACCE [primary safety]
时间窗: 30 days
major adverse cardiovascular events (MACCE)
LVESVi Reduction [primary efficacy]
时间窗: 6 month
left ventricular systolic volume index (LVESVi) reduction
次要结局
- Procedure Success(immediate)
- Rehospitalization(12 month)
- Mortality(12 month)
- Cardiac death(12 month)
- Incidence of MACCE(12 month)
- LVESVi Reduction(12 month)
- LVEF change(12 month)
- life quality(12 month)
- LVEDVi Reduction(12 month)
- Cardiac function(12 month)
- Walk tolerance(12 month)
研究者
Zhang Qi, MD
Chief of Cardiology Department, Rui Jin Hospital
Shanghai Jiao Tong University School of Medicine