Trials / Not Yet Recruiting
Not Yet RecruitingNCT07152574
ROTAO 1 - Feasibility and Safety of the TAVIPILOT Tele-operated Robot During Transcatheter Aortic Valve Replacement (TAVR/TAVI)
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- Caranx Medical · Industry
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-09-15
- Primary completion
- 2025-11-15
- Completion
- 2026-02-15
- First posted
- 2025-09-03
- Last updated
- 2025-09-03
Source: ClinicalTrials.gov record NCT07152574. Inclusion in this directory is not an endorsement.