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Feasibility and Safety of the Augmented Reality Guidance Software TAVIPILOT Software During Transcatheter Aortic Valve Replacement (TAVR/TAVI) in Australia
Sponsor: Caranx Medical
Summary
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.
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2025-09-15
Completion Date
2026-02-15
Last Updated
2025-08-14
Healthy Volunteers
No
Interventions
TAVR using a guidance software
TAVR procedure with TAVIPILOT augmented reality guidance software operating during the procedure, enabling clinicians to assess the live analysis and recommendations provided by the software.