The trial aims to evaluate the feasibility and safety of Caranx Medical TAVIPILOT augmented reality guidance software during Transcatheter Aortic Valve Replacement Procedures.
Patients aged ≥65
Indicated for transfemoral TAVR for severe aortic stenosis
None
Single group
TAVR using a guidance software
DeviceTAVR 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.
Investigational Device Safety
Exploratory evaluation of the technical robustness of the Investigational Device (TaviPilot Software) by evaluating the occurence of malfunctions while operating passively in parallel of the clinical procedure
Investigational Device Performance
Assess the performance of the device by comparing the valve implantation depth measured by the TaviPilot Software with the depth estimated by the investigator who performed the procedure.
Investigational Device Performance
Assessment of clinician satisfaction related to device usability and performance using custom made questionnaires
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
