SAITO1A is single center, 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.
A total of 10 subjects will be enrolled in one study site located in France.
Sponsor
Primary endpoints
The primary endpoint is to evaluate the software-related safety (absence of technical malfunctions).
CERC Services
- Clinical report
- Clinical trial documentation
- Electronic Data Capture Management
- Monitoring activities
- Project management
- Regulatory submissions
- Safety reporting
- Sites Contracts & Fees management
- Statistical Activities
Countries
France
Number of investigational sites
1
