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

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07152574

Enrollment

Registered

2025-09-03

Start date

2025-09-15

Completion date

2026-02-15

Last updated

2025-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TAVI(Transcatheter Aortic Valve Implantation)

Brief summary

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

DEVICETAVR 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Investigational Device Safety	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.

Secondary

Measure	Time frame	Description
Device Usability	Periprocedural	Evaluate clinical usability, assessed through customized questionnaires measuring clinician satisfaction, perceived ease of use, and integration of the devices into the procedural workflow.

Contacts

Primary ContactEric Sejor, MD

eric.sejor@caranx-medical.com09 82 24 85 61

Backup ContactChristophe Naz

christophe.naz.pro@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026