Feasibility and Safety of the Augmented Reality Guidance Software TAVIPILOT Software During Transcatheter Aortic Valve Replacement (TAVR/TAVI) in Australia
SAITO 1B
1 other identifier
interventional
10
0 countries
N/A
Brief Summary
The TAVIPILOT Software by Caranx Medical is an advanced intraoperative assistance tool designed to enhance the accuracy of transcatheter aortic valve positioning during TAVI. It works alongside conventional fluoroscopy, using real-time image analysis to provide precise anatomical landmarks. TAVIPILOT Software detects key anatomical structures, tracks valve positioning, and uses AI-based confidence indicators to assist in alignment. The software is compatible with approved C-arm imaging systems and specific catheter models. The objective is to assess the feasibility and safety of the TAVIPILOT Software augmented reality guidance software during TAVI procedures, aiming to improve valve positioning precision and, implicitly and to reduce implantation depth variations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2025
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2025
CompletedFirst Posted
Study publicly available on registry
August 14, 2025
CompletedStudy Start
First participant enrolled
September 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2026
CompletedAugust 14, 2025
August 1, 2025
2 months
August 12, 2025
August 12, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Investigational device-related 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.
Periprocedural
Investigational device-related safety
The investigational device-related safety will also be assessed by verifying the absence of major technical malfunctions.
Periprocedural
Secondary Outcomes (1)
Device usability
Periprocedural
Study Arms (1)
Experimental: TAVR procedure with TAVIPILOT Software (investigational medical device)
EXPERIMENTALUse of the TAVIPILOT Software during the procedure
Interventions
TAVR procedure with TAVIPILOT augmented reality guidance software operating during the procedure, enabling clinicians to assess the live analysis and recommendations provided by the software.
Eligibility Criteria
You may qualify if:
- Patients aged ≥65
- Indicated for transfemoral TAVR for severe aortic stenosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Caranx Medicallead
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2025
First Posted
August 14, 2025
Study Start
September 15, 2025
Primary Completion
November 15, 2025
Study Completion
February 15, 2026
Last Updated
August 14, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share