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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Caranx Medical • ClinicalTrials.gov ID: NCT07664163

Registry updated: 2026-09-09
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Description

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.

Interventions

  • TAVR procedure with TAVIPILOT Software and tele-operated robot by Caranx Medical enhancing the precision of transcatheter aortic valve positioning during TAVR. (Device)
    TAVR procedure with TAVIPILOT Software and tele-operated robot by Caranx Medical enhancing the precision of transcatheter aortic valve positioning during TAVR.

Eligibility criteria

Inclusion Criteria: 1. Patients aged ≥65 2. Indicated for transfemoral TAVR for severe aortic stenosis

Conditions

TAVI(Transcatheter Aortic Valve Implantation)

Locations

  • Macquarie University Hospital — Sydney, New South Wales, Australia
  • St Vincent's Hospital Sydney — Sydney, New South Wales, Australia
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record