NCT07043075

First-in-Human (FIH) Study on the Feasibility and Safety of the TaviPilot Augmented Reality Guidance Software

First-in-Human (FIH) Study on the Feasibility and Safety of the TaviPilot Augmented Reality Guidance Software Operated in Parallel Setup During Transcatheter Aortic Valve Implantation (TAVI) Without Influencing Clinical Decision-Making

• 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 trial aims to evaluate the feasibility and safety of Caranx Medical TAVIPILOT augmented reality guidance software during Transcatheter Aortic Valve Replacement Procedures.

Detailed description

The study is a prospective mono-center single-arm study to evaluate primarily the feasibility and safety of TAVIPILOT augmented reality guidance software during Transcatheter Aortic Valve Replacement Procedures (TAVR) for severe aortic stenosis. A series of parameters will be analysed to determine whether TAVIPILOT is a safe tool for valve positioning.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	TAVR using a guidance software	TAVR procedure with TAVIPILOT augmented reality guidance software operating in parallel on a separate screen in a blind setup, enabling clinicians to assess the analysis and recommendations provided by the software, either immediately after valve deployment or following the completion of the procedure.

Timeline

• Start date: 2025-08-01
• Primary completion: 2025-11-30
• Completion: 2026-05-30
• First posted: 2025-06-29
• Last updated: 2025-06-29