SAITO1B is prospective, single arm, First-In-Human study. The objective is to assess the feasibility and safety of the TaviPilot augmented reality guidance software during TAVI procedures, aiming to improve valve positioning precision and, implicitly, reduce implantation depth variations in patients aged ≥65 years indicated for transfemoral TAVI due to severe symptomatic aortic stenosis.
Up to 20 subjects will be enrolled across up to two study sites in France and one additional site in Europe.
Sponsor
Primary endpoints
- The primary endpoint is to evaluate procedure-related safety, including conversion to open-heart surgery and valve embolization, and software-related safety, by assessing the absence of technical malfunctions.
CERC Services
- Clinical report
- Clinical trial documentation
- Electronic Data Capture Management
- Monitoring activities
- Project management
- Regulatory submissions
- Safety reporting
- Sites' contract management
- Statistical Activities
Countries
France
Number of investigational sites
Up to 2 sites in Europe
