Feasibility and Safety of the Augmented Reality Guidance Software TAVIPILOT Software During Transcatheter Aortic Valve Replacement (TAVR/TAVI)
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-related safety
研究概览
简要总结
The TAVIPILOT Software by Caranx Medical is an advanced intraoperative assistance tool designed to enhance the accuracy of transcatheter aortic valve positioning during TAVI. It works alongside conventional fluoroscopy, using real-time image analysis to provide precise anatomical landmarks. TAVIPILOT Software detects key anatomical structures, tracks valve positioning, and uses AI-based confidence indicators to assist in alignment. The software is compatible with approved C-arm imaging systems and specific catheter models.
The objective is to assess the feasibility and safety of the TAVIPILOT Software augmented reality guidance software during TAVI procedures, aiming to improve valve positioning precision and, implicitly and to reduce implantation depth variations.
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
研究组 & 干预措施
TAVR procedure with TAVIPILOT Software (investigational medical device)
Use of the TAVIPILOT Software during the procedure
干预措施: TAVR using a guidance software (Device)
结局指标
主要结局
Investigational device-related safety
时间窗: Periprocedural
The investigational device-related safety will also be assessed by verifying the absence of major technical malfunctions.
Investigational device-related safety
时间窗: periprocedural
The primary objective is to evaluate investigational device-related safety, including the occurrence of investigational device-related conversion to open-heart surgery, investigational device-related valve embolization.
次要结局
- Device usability(Periprocedural)