TAVI(Transcatheter Aortic Valve Implantation)
Conditions
Brief summary
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.
Interventions
DEVICETAVR procedure with TAVIPILOT Software and tele-operated robot by Caranx Medical enhancing the precision of transcatheter aortic valve positioning during TAVR.
TAVR procedure with TAVIPILOT Software and tele-operated robot by Caranx Medical enhancing the precision of transcatheter aortic valve positioning during TAVR.
Sponsors
Caranx Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients aged ≥65 2. Indicated for transfemoral TAVR for severe aortic stenosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The investigational device-related safety will also be assessed by verifying the absence of major technical malfunctions | Periprocedural | Investigational Device Safety |
| 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. | Periprocedural | Investigational device-related safety |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Performance | Periprocedural | Assessment of the TAVIPILOT Robot ability to advance and retrieve the delivery system safely |
| Clinician satisfaction | Periprocedural | The assessment of clinician satisfaction with the investigational devices, using specific customized questionnaires |
Countries
Australia
Contacts
CONTACTDr Eric Sejor
CONTACTChristophe Naz
Outcome results
None listed