NCT05864456招募中不适用
Evaluation of the Safety and Efficacy of the Prizvalve Pro™ Transcatheter Aortic Valve System in the Treatment of Patients With Severe Aortic Valve Stenosis Disease at High Surgical Risk
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Composite endpoint event rate at 30 days
研究概览
简要总结
The purpose of this clinical trial is to evaluate the safety and efficacy of the Prizvalve Pro™ transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are not suitable for surgery.
详细描述
This study is a multicenter, single-arm, prospective clinical 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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years ;
- •Patients with symptomatic severe aortic valve stenosis (evaluated by echocardiography: transaortic valve pressure gradient ≥40mmHg (1mmHg=0.133kPa), or transaortic valve blood flow rate ≥4m/s, or aortic Valve area<1.0cm², or AVA <0.5cm² /m²);
- •Cardiac function NYHA ≥ II;
- •Life expectancy> 12 months;
- •Patients who are anatomically suitable for transcatheter aortic valve implantation;
- •Patients who have been evaluated by two or more cardiovascular surgeons as unsuitable for conventional surgery; or patients who have refused conventional surgery after adequate communication from the surgeon and who are at high risk for conventional surgery;
- •Patients who can understand the purpose of the trial and volunteer to participate in, sign the informed consent form and are willing to accept relevant examinations and clinical follow-ups.
排除标准
- •Acute myocardial infarction occurred within 1 month before this treatment;
- •Congenital unicuspid aortic valve;
- •Any therapeutic cardiac operation that is performed within 30 days of the index procedure (Previous PCI or implantation of a permanent pacemaker are not considered exclusion criteria);
- •Patients with other prosthetic heart valves, prosthetic rings already implanted in the heart, or severe mitral valve closure insufficiency (>3+);
- •Patients with hematologic disorders or abnormalities that make surgical treatment inappropriate;
- •Untreated severe coronary artery stenosis that requires revascularization;
- •Patients with hemodynamic or respiratory instability, requiring continuous mechanical heart assistance or mechanical ventilation;
- •Patients who need emergency surgery for any reason;
- •Patients with hypertrophic cardiomyopathy with obstruction;
- •Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) <20%;
- •Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
- •Patients with left ventricular outflow tract obstruction;
- •A history of acute peptic ulcer or upper gastrointestinal bleeding within 3 months;
- •Patients who are allergy or resistance to cobalt-chromium alloy, contrast agents and related components;
- •Patients who are unable to receive anticoagulation or antiplatelet therapy;
- •Cerebrovascular accident occurred within 3 months, not including transient ischemic attack;
- •Severe aortic diseases, including abdominal aortic or thoracic aortic aneurysm, etc;
- •Active infective endocarditis or other active infections;
- •Patients who have participated in clinical trials of other drugs or medical devices before enrollment and have not yet reached the primary outcome of research;
- •The investigator judged that patient with poor compliance and could not complete the study as required.
结局指标
主要结局
Composite endpoint event rate at 30 days
时间窗: 30 days after procedure
Composite endpoint event includes all-cause death, stroke, myocardial infarction, permanent pacemaker implantation, serious vascular and access-related complications, surgical intervention for aortic valve reoperation, valve-in-valve surgery.
次要结局
- Device success rate(Immediately after procedure)
- Improvement in cardiac function(1 day of discharge, 30 days, 1-5 year)
- Incidence of myocardial infarction(Immediately after procedure, 1 day of discharge, 30 days, 1-5 year)
- Incidence of disabling stroke(1 day of discharge, 30 days, 1-5 year)
- Procedural success rate(Immediately after procedure)
- Delivery system and component performance evaluation(Immediately after procedure)
- Valve function(Immediately after procedure, 1 day of discharge, 30 days, 1 year)
- Improvement in quality of life(30 days, 1 year)
- Incidence of serious vascular and access-related complications(Immediately after procedure, 1 day of discharge, 30 days, 1-5 year)
- Incidence of acute kidney injury(1 day of discharge, 30 days, 1-5 year)
- Incidence of other TAVI-related complications(Immediately after procedure, 1 day of discharge, 30 days, 1-5 year)
- Incidence of all-cause mortality(Immediately after procedure, 1 day of discharge, 30 days, 1-5 year)
- Incidence of permanent pacemaker implantation(1 day of discharge, 30 days, 1-5 year)
- Incidence of serious bleeding(1 day of discharge, 30 days, 1-5 year)
- Incidence of major cardiovascular and cerebrovascular adverse events(1 day of discharge, 30 days, 1-5 year)
研究者
研究点 (1)
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