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

Launched by CARANX MEDICAL · Jun 20, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new technology called TaviPilot, which uses augmented reality (a type of computer-generated imaging) to help doctors during a procedure called Transcatheter Aortic Valve Replacement (TAVR). This procedure is used to treat a condition called severe aortic valve stenosis, where the heart’s valve doesn’t open properly, making it harder for blood to flow. The main goal of the study is to see if this new software is safe to use and if it can help guide the procedure effectively.

The trial is looking for patients who are 65 years or older and who need the TAVR procedure through the blood vessels in the leg (called transfemoral TAVR) because of severe aortic valve stenosis. If you join the study, you can expect doctors to use the TaviPilot software during your TAVR procedure to assist them, while closely monitoring your safety throughout. This study is still in the early stages and is not yet recruiting participants, but it could lead to improved tools that help doctors perform this heart procedure more safely and accurately in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients aged ≥65
• • 2. Indicated for transfemoral TAVR for severe aortic stenosis