Feasibility and Safety of the Augmented Reality Guidance Software TAVIPILOT Software During Transcatheter Aortic Valve Replacement (TAVR/TAVI)

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.

NCT Number	NCT07100340
Lead Sponsor	Caranx Medical
Conditions	TAVI(Transcatheter Aortic Valve Implantation)
Enrollment	10 participants
Start Date	2025-09-15
Primary Completion	2025-11-15 (estimated)
Study Completion	2026-03-15 (estimated)
Updated on ClinicalTrials.gov	2025-08-03