NCT07121907

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Caranx Medical · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• TAVI(Transcatheter Aortic Valve Implantation)

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2025-09-15
• Primary completion: 2025-11-15
• Completion: 2026-02-15
• First posted: 2025-08-14
• Last updated: 2025-08-14

Regulatory

• FDA-regulated device study