First-in-Human (FIH) Study on the Feasibility and Safety of the TaviPilot Augmented Reality Guidance Software Operated in Parallel Setup During Transcatheter Aortic Valve Implantation (TAVI) Without Influencing Clinical Decision-Making
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 主要终点
- Investigational Device Safety
研究概览
简要总结
The trial aims to evaluate the feasibility and safety of Caranx Medical TAVIPILOT augmented reality guidance software during Transcatheter Aortic Valve Replacement Procedures.
详细描述
The study is a prospective mono-center single-arm study to evaluate primarily the feasibility and safety of TAVIPILOT augmented reality guidance software during Transcatheter Aortic Valve Replacement Procedures (TAVR) for severe aortic stenosis. A series of parameters will be analysed to determine whether TAVIPILOT is a safe tool for valve positioning.
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
- •Patients aged ≥65
- •Indicated for transfemoral TAVR for severe aortic stenosis
排除标准
- 未提供
结局指标
主要结局
Investigational Device Safety
时间窗: Peroperative
Exploratory evaluation of the technical robustness of the Investigational Device (TaviPilot Software) by evaluating the occurence of malfunctions while operating passively in parallel of the clinical procedure
次要结局
- Investigational Device Performance(Peroperative)