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NCT Number: NCT07100340

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

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.

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Key information

Conditions

TAVI(Transcatheter Aortic Valve Implantation)

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged ≥65
  • Indicated for transfemoral TAVR for severe aortic stenosis

Treatment and study plan

TAVR using a guidance software

Device

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.

Primary outcomes

  1. 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.

  2. Investigational device-related safety

    Time frame: Periprocedural

    The investigational device-related safety will also be assessed by verifying the absence of major technical malfunctions.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christophe Naz

CONTACT

[email protected]

Eric Sejor, MD

CONTACT

[email protected]

0033673335594

Sponsors and collaborators

Lead sponsor

Caranx Medical

Industry

Registry information

Acronym: SAITO 1B

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 3, 2025
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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