A Prospective, Multicenter, Single-armed Trial That Aims to Evaluate the Safety and Efficacy of Transcatheter Artificial Aortic Valve and Transcatheter Artificial Heart Values Delivery System
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 133
- 主要终点
- All-cause mortality
研究概览
简要总结
The purpose of this study is to demonstrate that transcatheter artificial aortic valve and transcatheter artificial heart values delivery system is associated with a reduction of all-cause mortality in severe aortic stenosis or insufficiency patients who are high risk or ineligible for aortic valve replacement.
详细描述
Aortic valve diseases is usually caused by rheumatic fever, congenital aortic valve structural abnormality or degenerative aortic valve calcification. Transcatheter aortic valve implantation (TAVI) has evolved as an alternative to surgical aortic valve replacement (SAVR) with now more than 50,000 implantations in patients with symptomatic severe aortic stenosis, who were considered to be at very high or prohibitive operative risk.
This project take the incidence of all-cause mortality at 12 months since TAVI as the primary endpoint to evaluate the safety and efficacy, then take the procedure success rate, device success rate, incidence of severe adverse events, device operative performance, prosthetic valve performance and quality of life to evaluate transcatheter artificial aortic valve and transcatheter artificial heart values delivery system of Ningbo Jenscare Biotechnology Co., Ltd. in clinical application.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects ≥ 65 years of age;
- •Severe aortic stenosis, as defined by ultrasonic cardiogram (peak velocity ≥4.0 m/s, or mean transaortic systolic pressure gradient ≥40 mmHg, or an aortic valve area of <1.0 cm2) or combined merger; severe aortic insufficiency (regurgitation ≥+++ or regurgitation area ≥0.3cm2) combined with left ventricular dilatation ( LVESD≥50mm or LVEDD≥65mm);or severe aortic valve insufficiency combined with left ventricular systolic dysfunction (LVEF<50%);
- •Symptoms suggestive of aortic stenosis, NYHA class III or IV;
- •Patients who are considered unsuitable for surgery are considered by two or more than two cardiovascular specialists (≥6% using Society of Thoracic Surgeons scoring system estimation; or there is a severe and irreversible organ damage to the patient, such as lung disease, liver disease, kidney disease and so on; or the patient's physical weakness can not be tolerated by surgery; or have other factors affecting surgery, such as postoperative chest radiosurgery, thoracic deformity, and diffuse severe calcification of the aorta, etc);
- •A life expectancy of > 1 year;
- •Voluntarily participate in and sign the informed consent form and willing to undergo the related examination and clinical follow-up.
排除标准
- •Untreated severe coronary stenosis and needs revascularization; or acute myocardial infarction occurred within 1 months, or coronary stent implantation in 1 month;
- •Artificial heart valve and artificial valve ring have been implanted；
- •Severe mitral insufficiency (regurgitation ≥+++) or mitral stenosis (valvular area<1.5 cm2)；
- •left ventricular or atrial thrombus;
- •Aortic annulus diameter <17mm or >27 mm;
- •Severe left ventricular dysfunction, ejection fraction <20%；
- •Severe pulmonary hypertension or severe right ventricular dysfunction；
- •The ascending aortic ≥5cm or Aortic root diameter ≥4.5cm;
- •Cerebrovascular event in last 3 months；
- •Active endocarditis or other active infection;
- •Severe renal failure and requires long-term dialysis treatment；
- •Severe liver dysfunction；
- •Active peptic ulcer；
- •Severe coagulation dysfunction; it is known that all anticoagulant schemes are taboo or allergic, or anticoagulants can not be used in the process of testing；
- •Severe respiratory failure；
- •Severe Alzheimer's disease；
- •Patients who were enrolled in any other study in one month;
- •Other cases which the researchers believe that it is not suitable to participate in.
研究组 & 干预措施
Jenscare TAVI
Patients undergoing a Jenscare TAVI and delivery system
干预措施: Jenscare TAVI (Device)
结局指标
主要结局
All-cause mortality
时间窗: 12 month
Cumulative incidence of a combination of all cause death at 12 month after TAVI
次要结局
- Procedure success rate(During the TAVI procedure)
- Evaluation and improvement of quality of life(Preoperative and 30 days, 3 months, 6 months, 12 months after TAVI)
- Device success rate(During the TAVI procedure)
- Incidence of severe adverse events(During the TAVI procedure and 3 days,7 days, 30 days, 3 months, 6 months, 12 months after TAVI)
- Assessment of device operative performance(During the TAVI procedure)
- Echocardiographic assessment of valve performance(30 days, 3 months, 6 months, 12 months after TAVI)