JENAVALVE ALIGN-AS TRIAL: Safety and Effectiveness/Performance of the Transfemoral JenaValve Pericardial TAVR System in the Treatment of Patients With Symptomatic Severe Aortic Stenosis (AS)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 68
- 试验地点
- 25
- 主要终点
- All-Cause Mortality
研究概览
简要总结
To collect information about treatment for severe aortic stenosis (AS), which affects the aortic valve in the heart. Aortic stenosis is a narrowing of the aortic valve opening, which decreases blood flow from the heart and causes symptoms such as chest pain, fainting and shortness of breath. The preferred treatment for severe aortic stenosis is aortic valve replacement surgery.
详细描述
This study will examine the use of a TAVR (Transcatheter Aortic Valve Replacement), which is a minimally invasive procedure designed to replace the aortic valve inside the heart. This less invasive surgical approach called TAVR is offered to those patients who are high risk for undergoing open heart surgery to replace the aortic valve. In this study, TAVR will be performed using the JenaValve Pericardial TAVR System.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with severe degenerative native aortic stenosis (AS).
- •Patient at high risk for open surgical valve replacement
- •Patient symptomatic according to NYHA functional class II or higher
排除标准
- •Congenital uni- or bicuspid aortic valve morphology
- •Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
- •Endocarditis or other active infection
- •Need for urgent or emergent TAVR procedure for any reason
- •Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device
结局指标
主要结局
All-Cause Mortality
时间窗: 30 Day
All-cause mortality rate at 30 Day
次要结局
- Myocardial Infarction(30 Day)
- Major Vascular Complication(30 Day)
- Conversion to Surgical Aortic Valve Replacement (SAVR)(30 Day)
- Major Bleeding(30 Day)
- Coronary Obstruction Requiring Intervention(30 Day)
- Endocarditis(30 Day)
- All Stroke/TIA(30 Day)
- Conduction Disturbance and Arrhythmias(30 Day)
- Acute Kidney Injury (AKI)(30 Day)
- THV Malpositioning(30 Day)