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SAIRO - Feasibility and Safety of the Tele-operated TAVIPILOT Robot Guided by TAVIPILOT Software

NCT07664163 · Caranx Medical · Updated 9 Sept 2026

What is being tested
TAVR procedure with TAVIPILOT Software and tele-operated robot by Caranx Medical enhancing the precision of transcatheter aortic valve positioning during TAVR.
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
Australia (2 sites)
When
Starts or started 10 Sept 2026, ends 1 May 2027. Registered 24 June 2026.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT07664163

Sites

  • Macquarie University HospitalSydney, New South Wales, Australia
  • St Vincent's Hospital SydneySydney, New South Wales, Australia