A Study to Assess Safety and Effectiveness of the JenaValve Trilogy™ Heart Valve System in the Treatment of High Surgical Risk Patients With Symptomatic, Severe Aortic Regurgitation (AR)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 180
- 试验地点
- 59
- 主要终点
- All Stroke
研究概览
简要总结
To collect information about treatment for symptomatic severe Aortic Regurgitation (AR), which affects the aortic valve in the heart. Aortic regurgitation is a condition where aortic valve in the heart does not close tightly and allows some blood to leak back into the heart chamber. Symptoms of aortic regurgitation may include fatigue and shortness of breath. The preferred treatment for severe aortic regurgitation is aortic valve replacement surgery.
详细描述
This study will examine the use of TAVR (Transcatheter Aortic Valve Replacement), which is a minimally invasive procedure designed to replace the aortic valve inside the heart. In this study, TAVR will be performed using the JenaValve Pericardial TAVR System, which is intended to help treat symptomatic severe aortic regurgitation.
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 aortic regurgitation (AR).
- •Patient at high risk for open surgical valve replacement
- •Patient symptomatic according to NYHA functional class II or higher
- •The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB)/ Ethics Committee (EC) of the respective clinical site.
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
- •Severe mitral regurgitation
结局指标
主要结局
All Stroke
时间窗: 30 days
Number of patients that had a stroke
Acute Kidney Injury
时间窗: 30 days
Number of patients that had these events
Major Vascular Complications
时间窗: 30 days
Number of patients that had these events
Surgery/intervention related to the device
时间窗: 30 days
Number of patients that had these events
Permanent pacemaker implantation
时间窗: 30 days
Number of patients that had these events
All-Cause Mortality at 1 Year
时间窗: 1 year
All-cause mortality within the first 12 months post index procedure
Major Bleeding
时间窗: 30 days
Number of patients that had any of these events
Total aortic regurgitation
时间窗: 30 days
Number of patients that had these events
次要结局
- KCCQ(1 year)