Feasibility and safety of using a tele-operated robot to guide TAVR with TAVIPILOT software

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study analyzes the feasibility and safety of the TAVIPILOT robotic platform, including its software and tele-operated robot, in guiding transcatheter aortic valve implantation. The system aims to improve valve alignment and deployment by enabling controlled, remote manipulation of delivery components within conventional lab workflows. Eligible participants are adults 65 years or older undergoing transfemoral TAVR for severe aortic stenosis. Procedures use the TAVIPILOT software in conjunction with the robotic system to potentially reduce operator variability during valve positioning. The study is conducted at two Sydney, Australia sites led by Caranx Medical as sponsor.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Where it's running

• Macquarie University Hospital
  Sydney, New South Wales, Australia Recruiting
• St Vincent's Hospital Sydney
  Sydney, New South Wales, Australia Recruiting

Study contacts

• Study coordinator: Dr Eric Sejor
• Email: eric.sejor@caranx-medical.com
• Phone: 09 82 24 85 61

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Dexmedetomidine conscious sedation to protect breathing and blood pressure during TAVI

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• Remote ECG monitoring after TAVI

  This compares continuous 30-day remote ECG monitoring to standard short-term monitoring for adults after TAVI to see if it detects rhythm problems earlier.

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• Intravenous iron infusion after transcatheter aortic valve implantation for people with iron deficiency

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  Recruiting Phase 4 Erasmus Medical Center · Rotterdam, South Holland · NCT07370688

• Savvywire versus standard LV guidewires during transfemoral TAVI

  For people 50 and older having transfemoral TAVI, researchers will compare the Savvywire and standard LV guidewires to see if the Savvywire improves pacing and procedure-related blood flow.

  Recruiting Catharina Ziekenhuis Eindhoven · Eindhoven, North Brabant · NCT07366671

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.