Randomized Comparison of Repositionable and Balloon-Expandable Prostheses in Patients Undergoing Trans-catheter Aortic Valve Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 5
- 主要终点
- Incidence of new permanent pacemaker implantation
研究概览
简要总结
There are different aortic valve prosthesis used for treatment of aortic valve disease through catheter-based procedures. The current study aims to compare two different aortic valve prosthesis regarding their outcomes at 30-day and 2-year follow-up.
详细描述
Important improvements in aortic valve prostheses technology has been made aiming comparable performance of these prosthesis to surgical valve ones.
The experience with the early generation of aortic valve prostheses revealed some important differences regarding the incidence of paravalvular leakage, need for pacemaker or valve thrombosis among them. Currently the new generations of valve prostheses such as Sapien 3 balloon-expandable valve and Lotus, repositionable valve are the most frequently used devices. There are registry data about the clinical performance of these valve types but a randomized comparison is missing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Symptomatic aortic valve disease in need of valve replacement
- •Heart team (including at least a cardiac surgeon and an interventional cardiologist) agrees on the eligibility that trans-femoral TAVI is appropriate.
- •Study patient is an adult of legal consent age.
- •Study patient has provided written informed consent to participate in the study
排除标准
- •Life expectancy < 12 months due to co-morbid conditions.
- •Native aortic valve annulus size and morphology not suitable for Lotus or Sapien prosthesis implantation
- •Preexisting bioprosthetic valve or ring in aortic valve position.
- •Pre-existing pacemaker or ICD/CRT.
- •Cardiogenic shock or hemodynamic instability.
- •History of active endocarditis
- •Contraindications for a trans-femoral access.
- •Severe left ventricular dysfunction with LVEF <30%.
- •Severe mitral valve insufficiency.
- •Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
- •Patients actively participating in another drug or device investigational study and have not yet completed the primary endpoint follow-up period.
- •Patients suffering from dementia.
- •Pregnant or nursing women
研究组 & 干预措施
repositionable valve prosthesis
Lotus
干预措施: repositionable valve prosthesis (Device)
balloon-expandable valve prosthesis
Sapien
干预措施: balloon-expandable valve prosthesis (Device)
结局指标
主要结局
Incidence of new permanent pacemaker implantation
时间窗: 30 days
implantation of PM
次要结局
- incidence of early safety parameters according to VARC-2 definitions(30 days)
- incidence of any prosthesis regurgitation(30 days)
- incidence of combined efficacy according to VARC-2 definitions(2 years)
- Incidence of any conduction abnormalities(30 days)
- Device success rate according to VARC-2 definition(30 days)
- Mortality rate(2 years)
研究者
Prof. Dr. Julinda Mehilli
Director, Interventional Cardiology
LMU Klinikum