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First-in-Human (FIH) Study on the Feasibility and Safety of the TaviPilot Augmented Reality Guidance Software

NCT07043075 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-06-29

No results posted yet for this study

Summary

The trial aims to evaluate the feasibility and safety of Caranx Medical TAVIPILOT augmented reality guidance software during Transcatheter Aortic Valve Replacement Procedures.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

TAVR using a guidance software

TAVR procedure with TAVIPILOT augmented reality guidance software operating in parallel on a separate screen in a blind setup, enabling clinicians to assess the analysis and recommendations provided by the software, either immediately after valve deployment or following the completion of the procedure.

Sponsors & Collaborators

  • Caranx Medical

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2025-11-30
Completion
2026-05-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07043075 on ClinicalTrials.gov