The trial aims to evaluate the feasibility and safety of Caranx Medical TAVIPILOT augmented reality guidance software during Transcatheter Aortic Valve Replacement Procedures.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
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
Time frame: Peroperative
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.
Time frame: Peroperative
Investigational Device Performance
Assessment of clinician satisfaction related to device usability and performance using custom made questionnaires
Time frame: Peroperative
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