Feasibility and Safety of the Augmented Reality Guidance Software TAVIPILOT Software During Transcatheter Aortic Valve Replacement (TAVR/TAVI) in Australia (SAITO 1B)

August 12, 2025 updated by: Caranx Medical

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: TAVR procedure with TAVIPILOT Software (investigational medical device)
Use of the TAVIPILOT Software during the procedure
Device: TAVR using a guidance software
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigational device-related safety
Time Frame: Periprocedural
The investigational device-related safety will also be assessed by verifying the absence of major technical malfunctions.
Periprocedural
Investigational device-related safety
Time Frame: 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.
Periprocedural

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device usability
Time Frame: Periprocedural
Evaluate clinical usability, assessed through customized questionnaires measuring clinician satisfaction, perceived ease of use, and integration of the devices into the procedural workflow.
Periprocedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Caranx Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 15, 2025

Primary Completion (Estimated)

November 15, 2025

Study Completion (Estimated)

February 15, 2026

Study Registration Dates

First Submitted

August 12, 2025

First Submitted That Met QC Criteria

August 12, 2025

First Posted (Actual)

August 14, 2025

Study Record Updates

Last Update Posted (Actual)

August 14, 2025

Last Update Submitted That Met QC Criteria

August 12, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 55004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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