SAIRO - Feasibility and Safety of the Tele-operated TAVIPILOT Robot Guided by TAVIPILOT Software
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorCaranx Medical
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged ≥65
Indicated for transfemoral TAVR for severe aortic stenosis
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
TAVR procedure with TAVIPILOT Software and tele-operated robot by Caranx Medical enhancing the precision of transcatheter aortic valve positioning during TAVR.
DeviceTAVR procedure with TAVIPILOT Software and tele-operated robot by Caranx Medical enhancing the precision of transcatheter aortic valve positioning during TAVR.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Use of tele-operated TAVIPILOT Software and Robot during the procedureExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The investigational device-related safety will also be assessed by verifying the absence of major technical malfunctions
Investigational Device Safety
Time frame
Periprocedural2
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.
Investigational device-related safety
Time frame
PeriproceduralSecondary outcomes
1
Device Performance
Assessment of the TAVIPILOT Robot ability to advance and retrieve the delivery system safely
Time frame
Periprocedural2
Clinician satisfaction
The assessment of clinician satisfaction with the investigational devices, using specific customized questionnaires
Time frame
PeriproceduralSponsors and contacts
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Source ClinicalTrials.gov