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

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.

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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

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 using a tele-operated Robot

Device

TAVR procedure with TAVIPILOT tele-operated robot by Caranx Medical enhancing the precision of transcatheter aortic valve positioning during TAVR.

Primary outcomes

Investigational Device Safety

Time frame: Periprocedural

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 trauma during progression through the ascending aorta and the native valve.
Investigational Device Safety

Time frame: Periprocedural

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

Secondary outcomes

Device Usability

Time frame: Periprocedural

Evaluate clinical usability, assessed through customized questionnaires measuring clinician satisfaction, perceived ease of use, and integration of the devices into the procedural workflow.

Study contacts

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

Christophe Naz

CONTACT

[email protected]

Eric Sejor, MD

CONTACT

[email protected]

09 82 24 85 61 ext. +33

Sponsors and collaborators

Lead sponsor

Caranx Medical

Industry

Registry information

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Sep 3, 2025
Registry last updated: Sep 3, 2025

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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