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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorCaranx Medical

About this trial

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.

Eligibility criteria

Qualifiers

Patients aged ≥65

Indicated for transfemoral TAVR for severe aortic stenosis

Disqualifiers

None

Trial design

Treatments tested in this trial

  • TAVR using a tele-operated Robot

Treatment groups

10 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators