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

Caranx Medical

Status: Not yet enrolling

Conditions: TAVI(Transcatheter Aortic Valve Implantation)

Treatments: Device: TAVR using a guidance software

Study type: Interventional

Funder types: Industry

Identifiers

NCT07100340

55003

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

TAVR procedure with TAVIPILOT Software (investigational medical device)

Experimental group

Description:

Use of the TAVIPILOT Software during the procedure

Treatment:

Device: TAVR using a guidance software