TAVI(Transcatheter Aortic Valve Implantation)SAIRONCT07664163
SAIRO - Feasibility and Safety of the Tele-operated TAVIPILOT Robot Guided by TAVIPILOT Software
A study testing TAVR procedure with TAVIPILOT Software and tele-operated robot by Caranx Medical enhancing the precision of transcatheter aortic valve positioning during TAVR. in people with TAVI(Transcatheter Aortic Valve Implantation), run by Caranx Medical at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- TAVI(Transcatheter Aortic Valve Implantation)
- What is being tested?
- TAVR procedure with TAVIPILOT Software and tele-operated robot by Caranx Medical enhancing the precision of transcatheter aortic valve positioning during TAVR.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesAustralia
- Study dates
- 10 Sep 2026to 1 May 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients aged ≥65
- Indicated for transfemoral TAVR for severe aortic stenosis
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Christophe Naz contact
Australia2 sites, 2 recruiting
- Recruiting
Macquarie University Hospital
Sydney, New South Wales, 2109
Amy Johnson Clinical Trial Coordinator, +61(4) 79 187 608, amy.johnson@mq.edu.au
- Recruiting
St Vincent's Hospital Sydney
Sydney, New South Wales
Erika O'Dea Research and Structural Heart Coordinator, +61 (4) 12 806 682, erika.odea@svha.org.au
About this study
Official title: SAIRO - Feasibility and Safety of the Tele-operated TAVIPILOT Robot Guided by TAVIPILOT Software During Transcatheter Aortic Valve Replacement (TAVR/TAVI)
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.
- Being tested
- TAVR procedure with TAVIPILOT Software and tele-operated robot by Caranx Medical enhancing the precision of transcatheter aortic valve positioning during TAVR.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVR procedure with TAVIPILOT Software and tele-operated robot by Caranx Medical enhancing the precision of transcatheter aortic valve positioning during TAVR.Device
TAVR procedure with TAVIPILOT Software and tele-operated robot by Caranx Medical enhancing the precision of transcatheter aortic valve positioning during TAVR.
| Study group | Role | What they receive |
|---|---|---|
| Use of tele-operated TAVIPILOT Software and Robot during the procedure | Experimental | TAVR procedure with TAVIPILOT Software and tele-operated robot by Caranx Medical enhancing the precision of transcatheter aortic valve positioning during TAVR. Receives: Device: TAVR procedure with TAVIPILOT Software and tele-operated robot by Caranx Medical enhancing the precision of transcatheter aortic valve positioning during TAVR. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The investigational device-related safety will also be assessed by verifying the absence of major technical malfunctions
Investigational Device Safety
Measured: 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.
Investigational device-related safety
Measured: Periprocedural
Secondary outcomes (2)
Device Performance
Assessment of the TAVIPILOT Robot ability to advance and retrieve the delivery system safely
Measured: Periprocedural
Clinician satisfaction
The assessment of clinician satisfaction with the investigational devices, using specific customized questionnaires
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start10 Sep 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TAVI(Transcatheter Aortic Valve Implantation)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Caranx Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664163
- Sponsor's protocol ID
- 55006
- Acronym
- SAIRO
- Status last verified
- Sep 2026
- First submitted
- 3 Feb 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No