ROTAO 1 - Feasibility and Safety of the TAVIPILOT Tele-operated Robot During Transcatheter Aortic Valve Replacement (TAVR/TAVI)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TAVR using a tele-operated Robot.
- Who it may be relevant to
- Registry conditions: TAVI(Transcatheter Aortic Valve Implantation). Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device TAVR using a tele-operated Robot
TAVR procedure with TAVIPILOT tele-operated robot by Caranx Medical enhancing the precision of transcatheter aortic valve positioning during TAVR.
Primary outcome measures
- Investigational Device Safety [Time frame: Periprocedural]
- Investigational Device Safety [Time frame: Periprocedural]
Secondary outcome measures (1)
- Device Usability [Time frame: Periprocedural]
Eligibility criteria
Inclusion criteria
- Patients aged ≥65
- Indicated for transfemoral TAVR for severe aortic stenosis
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07152574 · 55005