NCT05580952招募中不适用
Efficacy and Safety of the J-Valve Transcatheter Aortic Valve Replacement System in Patients With Aortic Regurgitation Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 15
- 主要终点
- Cumulative all-cause mortality
研究概览
简要总结
The purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic regurgitation disease who are at high or prohibitive surgical risk.
详细描述
This study is a prospective, multicenter, single-arm, 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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic aortic valve regurgitation diseases, and New York Heart Association (NYHA) ≥ II;
- •Subject must have Society of Thoracic Surgeons (STS) score ≥8% or have been evaluated as inoperable by the surgical team [defined as rate of death >50% within 30 d post-surgery or accompanied with irreversible occasions of other factors prevent surgeries (such as heavily calcified (porcelain) ascending aorta, weakness, chest malformation, liver dysfunction, pulmonary dysfunction and so on ); (Note: age of inoperable patients can be expanded to ≥ 50);
- •Aortic valve anatomy is suitable for TAVR evaluated by the investigators;
- •Patients who can sign informed consent form, and are willing to accept relevant examinations and clinical follow-ups.
排除标准
- •Active endocarditis;
- •Acute myocardial infarction or coronary revascularization occurred within 1 month before procedure;
- •Cerebrovascular accident (CVA) occurred within 30 days before procedure;
- •The echocardiogram indicates the presence of mass, thrombus or vegetation in left ventricle and left atrium;
- •Hypertrophic obstructive cardiomyopathy;
- •Other valve diseases that need interventions;
- •Previous aortic valve implantation (mechanical or biological);
- •Allergic to Nickel-titanium alloys or contrast agents or cattle-originated products;
- •Known allergy or contraindication to all anticoagulation, or anticoagulation can not be used during the TAVR;
- •In presence one of the following (from selection to the day of procedure index):
- •a other diseases that may shorten life expectancy to less than 12 months (recurrent or metastatic cancer, congestive heart failure); b drug abuse (such as cocaine, heroin and so on); c planned additional operations that may result in incompliance or data confusion;
- •Stenosis of common carotid artery, internal carotid artery or vertebral artery >70%;
- •Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) <20%;
- •Hepatic encephalopathy or acute active hepatitis;
- •Receiving hemodialysis;
- •Bleeding tendency or history of coagulopathy or refuse to receive transfusion;
- •Active gastrointestinal (GI) ulcer or bleeding;
- •Severe dementia;
- •Patients who need emergency surgery for any reason;
- •Patients are participating in other drugs or medical devices clinical trial;
- •Pregnant or plan to be pregnant, or are taking estrogen or estrogen-like drugs (Women suspected of pregnancy must have a negative serum or urine test for human villous gonadotropin prior to enrollment in the study);
- •Other inappropriate occasions according to the investigators.
结局指标
主要结局
Cumulative all-cause mortality
时间窗: 12 months
All-cause mortality within 12 months of TAVR procedure
次要结局
- Device success(30 days)
- Procedural success(immediate post-surgical)
- Evaluation of bioprosthetic valve and cardiac function(30 days, 6 months, 12 months)
- Conduction block and malignant arrhythmia(before discharge, 30 days, 6 months, 12 months)
- Permanent pacemaker implantation(before discharge, 30 days, 6 months, 12 months)
- Functional Improvement of heart ( NYHA）(30 days, 6 months, 12 months)
- Quality of life（KCCQ）(30 days, 6 months, 12 months)
- Major cardiovascular and cerebrovascular adverse events (MACCE)(before discharge, 30 days, 6 months, 12 months)
- Myocardial infarction(before discharge, 30 days, 6 months, 12 months)
- Stroke(before discharge, 30 days, 6 months, 12 months)
- Major bleeding (life-threatening or crippling)(before discharge, 30 days, 6 months, 12 months)
- Acute kidney injury(before discharge, 30 days, 6 months, 12 months)
- The incidence of adverse events(12 months)
- TAVI related complications(before discharge, 30 days, 6 months, 12 months)
- Device defects(intraoperative)
- The incidence of serious adverse events(12 months)
研究者
研究点 (15)
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