NCT04893603招募中不适用
A Prospective, Multi-center, Single-arm Clinical Trial to Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Stenosis With or Without Moderate or Lower Degree Regurgitation
Chengdu Silara Meditech Inc.1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年12月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Rate of All-cause Mortality
研究概览
简要总结
To Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System ( Chengdu Silara Medtech Inc. ,Chengdu, China)in Patients with Severe Aortic Stenosis with or without Moderate or Lower Degree Regurgitation
详细描述
Transcatheter Aortic Valve System (Chengdu Silara Medtech Inc. ,Chengdu, China) will be used for this study.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥70 years old;
- •Symptomatic severe aortic stenosis determined by echocardiogram, defined as: mean gradient ≥40 mmHg or peak jet velocity ≥4.0 m/s, or an aortic valve area <0.8 cm2 or aortic valve area index <0.5 cm2/m
- •NYHA Functional Class ≥II;
- •Life expectancy after aortic valve implantation thought to be >1 year;
- •Native valvular or peripheral vascular anatomy is appropriate for TAVR;
- •Patient is assessed by at least two cardiothoracic surgeons and recorded as not suitable for surgery;
- •Patient can understand the purpose of the study, voluntarily participates and signs the informed consent form and is willing to accept the relevant examination and clinical follow-up visits.
排除标准
- •Anatomy is not appropriate for percutaneous valve implantation. Native valve annulus diameter is not in the scope of application(native TAV diameter ≤21mm, or ≥30mm);
- •Evidence of an acute myocardial infarction within 30 days prior to the study procedure, defined as: Q-wave myocardial infarction, or non-Q-wave myocardial infarction, with CK-MB≥2 ULN/or elevated TN (WHO definition);
- •Any treatment for traumatic cardiac surgery within 30 day prior to the study procedure(except coronary revascularization);
- •Pre-existing prosthetic valve in any position(except severely dysfunctional aortic bioprosthesis), or severe (>3+) mitral insufficiency, or Gorlin syndrome;
- •Hematological abnormality, defined as: Leukopenia (WBC <3x10^9/L), acute anemia (Hb <90g/L), or thrombocytopenia (platelet count<50×109/L),history of bleeding diathesis or coagulopathy;
- •Hemodynamic unstable requiring myocardial contractile support or mechanical cardiac assistance;
- •Severe ventricular insufficiency. Left ventricular ejection fraction (LVEF) <20%;
- •Echocardiographic evidence of intra-cardiac thrombus or vegetation etc.;
- •Active pepticulcer or upper GI bleeding within 3 months prior to the study procedure;
- •Cerebral Vascular Accident (CVA) within 3 months prior to the study procedure, including TIA;
- •A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, or sensitivity to contrast media, which cannot be adequately pre-medicated;
- •Patients with infective endocarditis or other active stage of infection;
- •Currently participating in an investigational drug or another device trial.
结局指标
主要结局
Rate of All-cause Mortality
时间窗: 12 months
Percentage of subjects who died from all causes in this population.
次要结局
- Quality of Life Assessment(30 days, 6 months,and 12 months)
- Incidence of Stroke(7 days /discharge, 30 days, 6 months, 12 months and 2-5 years.)
- Exchange Systerm Evaluation(Immediate post- procedure)
- Valvular function evaluation, including valve stenosis, AR, valve function(e.g. EOA, gradient) and PVL(Immediate post-procedure, 7days or discharge, 30 days, 6 months ,12months and 2-5 years)
- Delivery System Performance(Immediate post- procedure)
- Rate of Procedure Success(Immediate post- procedure)
- Incidence of AKI (stage 2 and 3,or renal replacement therapy (RRT: Hemodialysis, abdomen Cavity dialysis, hemofiltration))(7 days /discharge, 30 days, 6 months, 12 months and 2-5 years.)
- Incidence of Permanent Pacemaker Implantation(7 days /discharge, 30 days, 6 months, 12 months and 2-5 years.)
- Incidence of Conduction disturbances and cardiac arrhythmias(Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 month and 2-5years)
- Rate of Device Success(Immediate post- procedure)
- Retrieval System Performance(if using)(Immediate post- procedure)
- Rate of All-cause Mortality(Immediate post- procedure ,7 days /discharge, 30 days, 6 months and 2-5 years.)
- NYHA function(7 days or discharge, 30 days, 6 months ,12 months and 2-5 years)
- Incidence of Myocardial Infarction(Immediate post- procedure, 7 days /discharge, 30 days, 6 months ,12months and 2-5 years.)
- Incidence of MACCE(including mortality, stroke, MI, re-procedure, Conduction disturbances and cardiac arrhythmias)(Immediate post- procedure, 7 days /discharge, 30 days, 6 months,12months and 2-5 years.)
- Incidence of Bleeding (life-threatening or disabling and major)(Immediate post- procedure, 7 days /discharge, 30 days, 6 months,12months and 2-5 years.)
- Incidence of major vascular complications(Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 months.)
- Incidence of Other TAVI-related Complications(Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 month and 2-5years)
研究者
研究点 (1)
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