NCT04744857已完成不适用
A Prospective，Multicenter, Single-arm Clinical Trial to Evaluate Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve Replacement System With Retrievable Delivery Catheter System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Composite event rate at 30 days
研究概览
简要总结
The TaurusOne® transcatheter aortic valve system with retrievable delivery catheter system is evaluated the safety and effectiveness for the delivery of artificial aortic valve in a prospective, multicenter, single-arm clinical trial.
详细描述
The TaurusOne® transcatheter aortic valve system with retrievable delivery catheter system is evaluated the safety and effectiveness for the delivery of artificial aortic valve in a prospective, multicenter, single-arm clinical trial. According to the inclusion and exclusion criteria, sixty patients are planed been enrolled and implanted with TaurusOne® .Patients are seen at pre and post procedure, discharge, 30 days. The main follow-up included clinical symptoms and signs, cardiac ultrasound, CT, etc. The outcome included immediate device success, procedure success, And the major cardiovascular and cerebrovascular adverse events (MACCE, including mortality, stroke, myocardial infarction, reoperation, arrhythmia, conduction block).
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
- •Patients who are willing to participate and sign the informed consent and can cooperate with the whole trial process;
- •Age ≥70 years old;
- •Patients with severe calcified aortic stenosis confirmed by echocardiography (trans-aortic valve flow velocity ≥ 4.0m /s, or trans-active valvular pressure difference ≥40mmHg (1mmHg=0.133kPa), or aortic valve orientation area < 0.8cm2, or effective aortic valve orifice the product index is < 0.5cm2/m2);
- •Appear obvious symptoms caused by aortic stenosis, NYHA class Ⅱ or higher;
- •The cardiac team (at least two specialists in cardiovascular surgery) assessed the patient as unsuitable for routine surgery ;
- •The life expectancy of the patient after implantation of the prosthetic valve was evaluated by the cardiac team (at least two specialists in cardiovascular surgery) as more than one year;
- •Patients with aortic ring diameter ≥18mm and ≤29mm (cardiac CT measurement);
- •The diameter of the ascending aorta of the patient was < 50mm.
排除标准
- •Patients with bacteremia or toxemia;
- •previous history or active endocarditis;
- •Acute myocardial infarction (Q-wave MI, or non-Q-wave MI with increased creatine kinase isoenzyme and/or troponin T) within 30 days;
- •Echocardiography found any intracardiac mass, left ventricle or atrial thrombosis, vegetations;
- •Symptomatic atrial fibrillation that cannot be improved by medication;
- •Familial hypertrophic cardiomyopathy;
- •Mitral valve and tricuspid valve insufficiency (reflux Ⅱ level above);
- •Prior aortic valve grafts (mechanical or biological valve stents);
- •Known allergy to contrast agent, aspirin, heparin, ticlopidine, nickel-titanium memory alloy, or bovine products;
- •Known to be contraindication or allergic to all anticoagulant regimens, or unable to use anticoagulant during the test;
- •Other serious diseases that may reduce life expectancy to less than 12 months (e.g. clinically recurrent or metastatic cancer, congestive heart failure, etc.)
- •Current drug abuse problem (e.g., alcohol, cocaine, heroin, etc.); Plan to undergo surgery that may cause nonadherence to protocol or confusion in data interpretation.
- •Cerebrovascular accident (CVA) in the past 6 months;
- •Patients with common or internal carotid or vertebral artery stenosis (> 70%);
- •WBC count < 3×109/L, platelet count < 50×109/ L;
- •Hemoglobin < 90g/L;
- •Patients with severe coagulation dysfunction;
- •Severe left ventricular dysfunction, left ventricular ejection fraction < 20%;
- •Abdominal or thoracic aortic aneurysm;
- •Hepatic encephalopathy or acute active hepatitis;
- •Receiving dialysis or a baseline creatinine level of > 3.0 mg/dL (266μmol/L);
- •Have bleeding tendency or history of coagulation disease or refuse blood transfusion;
- •Have active gastric ulcer or active gastrointestinal (GI) bleeding;
- •Suffer from neurological diseases that seriously affect the ability to move or live in daily life;
- •People with mental illness or mental disorder who cannot express themselves normally;
- •Need emergency surgery for any reason;
- •Screening participants who had participated in other drug or medical device clinical trials within the previous 3 months;
- •Other conditions considered by the investigator to be inappropriate for participation in this clinical trial.
结局指标
主要结局
Composite event rate at 30 days
时间窗: 30 days after procedure
Patient-oriented composite event including all-cause death，severe stroke，myocardial infarction, permanent pacemaker implantation，surgical reoperation and valve-in-valve.
次要结局
- Device success rate (immediately after procedure)(Immediately after procedure)
- Procedure success rate(72 hours after procedure/prior to discharge)
- Cardiac function improvement(30 days after procedure)
- Quality of life of patients(30 days after procedure)
研究者
研究点 (1)
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