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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.
Age
65 - No limit years
Sex
ALL
Healthy Volunteers
No
Start Date
September 15, 2025
Primary Completion Date
November 15, 2025
Completion Date
March 15, 2026
Last Updated
August 3, 2025
10
ESTIMATED participants
TAVR using a guidance software
DEVICE
Lead Sponsor
Caranx Medical
NCT07366671
NCT07317804
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