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NCT Number: NCT07664163

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

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.

Recruiting

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Key information

Conditions

TAVI(Transcatheter Aortic Valve Implantation)

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Macquarie University Hospital, Sydney, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged ≥65
  • Indicated for transfemoral TAVR for severe aortic stenosis

Treatment and study plan

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.

Primary outcomes

  1. The investigational device-related safety will also be assessed by verifying the absence of major technical malfunctions

    Time frame: Periprocedural

    Investigational Device Safety

  2. The primary objective is to evaluate investigational device-related safety, including the occurrence of investigational device-related conversion to open-heart surgery, investigational device-related valve embolization and investigational device-related.

    Time frame: Periprocedural

    Investigational device-related safety

Secondary outcomes

  1. Device Performance

    Time frame: Periprocedural

    Assessment of the TAVIPILOT Robot ability to advance and retrieve the delivery system safely

  2. Clinician satisfaction

    Time frame: Periprocedural

    The assessment of clinician satisfaction with the investigational devices, using specific customized questionnaires

Study contacts

Contact information is provided by the study sponsor or research team.

Christophe Naz

CONTACT

[email protected]

Dr Eric Sejor

CONTACT

[email protected]

09 82 24 85 61 ext. +33

Sponsors and collaborators

Lead sponsor

Caranx Medical

Industry

Registry information

Official study title

SAIRO - Feasibility and Safety of the Tele-operated TAVIPILOT Robot Guided by TAVIPILOT Software During Transcatheter Aortic Valve Replacement (TAVR/TAVI)

Acronym: SAIRO

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 24, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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