Clinical Trial

ROTAO 1 - Feasibility and Safety of the TAVIPILOT Tele-operated Robot During Transcatheter Aortic Valve Replacement (TAVR/TAVI)

Not Yet Recruiting
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Record status
This record was last updated September 3, 2025 (before its estimated November 15, 2025 completion). Its status may not reflect the trial's current state.
Summary
The TAVIPILOT tele-operated robot by Caranx Medical is an advanced intraoperative robotic assistance system designed to enhance the precision of transcatheter aortic valve positioning during TAVR. The system integrates with standard procedural workflows and enables remote manipulation of delivery system components, allowing for controlled, stable, and reproducible movements. TAVIPILOT facilitates accurate valve alignment and deployment, reducing operator variability. The robot is compatible with approved balloon-expandable transcatheter heart valves (Sapien 3 and Ultra, Edwards Lifesciences, USA) and standard catheterization lab infrastructure.
Trial Details
NCT Number NCT07152574
Lead Sponsor Caranx Medical
Conditions TAVI(Transcatheter Aortic Valve Implantation)
Enrollment 10 participants
Start Date 2025-09-15
Primary Completion 2025-11-15 (estimated)
Study Completion 2026-02-15 (estimated)
Updated on ClinicalTrials.gov 2025-09-03