NCT04815785进行中（未招募）不适用
A Multicenter, Prospective, Single-Arm, Objective Performance Criteria Study to Evaluate the Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- All-cause mortality at 12 months
研究概览
简要总结
To observe and evaluate the safety and efficacy of TaurusOne® transcatheter aortic valve system in patients with severe calcific aortic stenosis through a prospective, multicenter clinical trial using objective performance criteria.
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 voluntarily participate and sign the informed consent and are able to comply with the entire trial process;
- •Age ≥ 70 years;
- •Patients with severe calcific aortic stenosis confirmed by echocardiography (Transaortic flow velocity ≥ 4.0 m/s, or aortic-valve gradient ≥ 40 mmHg (1 mmHg = 0.133 kPa), or aortic valve area < 0.8 cm2, or effective orifice area < 0.5 cm2/m2);
- •Patients who have symptoms obviously caused by aortic stenosis, NYHA Class II or worse;
- •Patients who are unsuitable for conventional surgery evaluated by the cardiac team (including at least two cardiovascular surgeons) [13] *;
- •Life expectancy after implantation of prosthetic valve is more than one year evaluated by the cardiac team (including at least two cardiac surgeons);
- •Aortic annulus diameter ≥ 18 mm and ≤ 29 mm (measured by cardiac CT);
- •Ascending aorta diameter < 50 mm
- •*: If the patient meets any of the following criteria judged by a multidisciplinary cardiac team composed of cardiologists and cardiovascular surgeons, radiologists, anesthesiologists, etc. (at least two cardiovascular surgeons), the patient will be identified as unsuitable for conventional surgery (at least STS ≥ 8 points):
- •Estimated risk of surgery-related death or disability > 50% within 1 year;
- •≥3 major organ damage that could not be improved by surgery;
- •Obstacles related to surgical procedures judged as serious
排除标准
- •Patients with bacteremia or toxemia;
- •Previous endocarditis or active endocarditis;
- •Acute myocardial infarction (Q-wave MI, or non-Q-wave MI with elevated creatine kinase isoenzyme and troponin T) within 30 days;
- •Any intracardiac mass, left ventricular or atrial thrombus, vegetation on echocardiography;
- •Symptomatic atrial fibrillation that cannot be improved by drug therapy;
- •Familial hypertrophic cardiomyopathy;
- •Mitral or tricuspid valve insufficiency (grade II regurgitation or higher);
- •Previous aortic valve graft (mechanical or bioprosthetic valve);
- •Known allergies to contrast agents, aspirin, heparin, ticlopidine drugs, nitinol shape memory alloy, or bovine products;
- •Known contraindications or allergies to anticoagulant regimens, or inability to use anticoagulants throughout the trial;
- •Other serious diseases that may reduce life expectancy to less than 12 months (such as clinically recurrent or metastatic cancer, congestive heart failure, etc.);
- •Current substance abuse problems (e.g., alcohol, cocaine, heroin, etc.);
- •Scheduled to undergo surgery that may result in protocol noncompliance or confounding in data interpretation.
- •Cerebrovascular accident (CVA) in the past 6 months;
- •Patients with common carotid artery or internal carotid artery or vertebral artery stenosis (>70%);
- •White blood cell count <3×109/L, platelet count <50×109/L;
- •Hemoglobin < 90 g/L;
- •Patients with severe coagulopathy;
- •Severe left ventricular dysfunction, left ventricular ejection fraction < 20%;
- •Abdominal or thoracic aortic aneurysm;
- •Hepatic encephalopathy or acute active hepatitis;
- •On dialysis or baseline creatinine level > 2.5 mg/dL (221 μ mol/L);
- •Bleeding tendency or history of coagulation disease or refusal of blood transfusion;
- •Patients with active peptic ulcer or active gastrointestinal (GI) bleeding;
- •Patients with neurological diseases that seriously affect mobility and activities of daily living;
- •Patients with mental illness or psychological disorders who are unable to communicate effectively;
- •Patients who need emergency surgery for any reason;
- •Patients who have participated in other drug or medical device clinical trials within 3 months prior to screening;
- •Other conditions that make the patient ineligible to participate in this clinical trial in judgement of investigators
研究组 & 干预措施
A single set of test
Experimental
The experimental apparatus consisted of artificial aortic valve, transporter and loading system
干预措施: TaurusOne® transcatheter aortic valve replacement system (Device)
结局指标
主要结局
All-cause mortality at 12 months
时间窗: 12 months
All-cause mortality
次要结局
- Device success rate (Immediate after procedure)(Immediate after procedure)
- Procedure success rate(72 hours after procedure/prior to discharge)
- Cardiac function improvement(30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years)
研究者
研究点 (1)
Loading locations...
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