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ROTAO 1 - Feasibility and Safety of the TAVIPILOT Tele-operated Robot During Transcatheter Aortic Valve Replacement (TAVR/TAVI)
NCT07152574 · Caranx Medical · Updated 3 Sept 2025
- What is being tested
- TAVR using a tele-operated Robot
- For
- TAVI(Transcatheter Aortic Valve Implantation)
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 65 years and older. About 10 people. The full rules are on the registry page.
- Where
- Not stated
- When
- Starts or started 15 Sept 2025, ends 15 Feb 2026. Registered 3 Sept 2025.
- Results
- None posted yet.
In the researchers' words
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.