First-in-Human (FIH) Study on the Feasibility and Safety of the TaviPilot Augmented Reality Guidance Software
Launched by CARANX MEDICAL · Jun 20, 2025
Trial Information
Current as of July 24, 2025
Not yet recruiting
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
About Caranx Medical
Caranx Medical is a clinical trial sponsor specializing in the development and advancement of innovative medical devices and therapeutic solutions. Committed to improving patient outcomes, Caranx Medical focuses on rigorous research and collaboration with healthcare professionals to bring cutting-edge technologies from concept to clinical application. Their expertise spans various medical fields, emphasizing safety, efficacy, and regulatory compliance throughout the clinical trial process.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported