The TAVIPILOT robotic platform, developed by Caranx Medical is an advanced intraoperative robotic assistance system designed to enhance the precision of transcatheter aortic valve positioning during TAVR. The TAVIPILOT robotic platform includes the TAVIPILOT Software, Robot (when controlled by the user) and Loop (when guided by the Software). The system integrates with standard procedural workflows and enables remote manipulation of delivery system components, allowing for controlled, stable, and reproducible movements. TAVIPILOT devices facilitate accurate valve alignment and deployment, reducing operator variability. The robot is compatible with commercially approved balloon-expandable transcatheter heart valves (Sapien 3 and Ultra, Edwards Lifesciences, USA) and standard catheterization lab infrastructure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
TAVR procedure with TAVIPILOT Software and tele-operated robot by Caranx Medical enhancing the precision of transcatheter aortic valve positioning during TAVR.
Macquarie University Hospital
Sydney, New South Wales, Australia
RECRUITINGSt Vincent's Hospital Sydney
Sydney, New South Wales, Australia
RECRUITINGThe investigational device-related safety will also be assessed by verifying the absence of major technical malfunctions
Investigational Device Safety
Time frame: Periprocedural
The primary objective is to evaluate investigational device-related safety, including the occurrence of investigational device-related conversion to open-heart surgery, investigational device-related valve embolization and investigational device-related.
Investigational device-related safety
Time frame: Periprocedural
Device Performance
Assessment of the TAVIPILOT Robot ability to advance and retrieve the delivery system safely
Time frame: Periprocedural
Clinician satisfaction
The assessment of clinician satisfaction with the investigational devices, using specific customized questionnaires
Time frame: Periprocedural
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.