NCT07043075

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Aug 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Aug 2025May 2026

First Submitted

Initial submission to the registry

June 4, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 29, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Expected
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

June 4, 2025

Last Update Submit

June 20, 2025

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

  • Investigational Device Safety

    Exploratory evaluation of the technical robustness of the Investigational Device (TaviPilot Software) by evaluating the occurence of malfunctions while operating passively in parallel of the clinical procedure

    Peroperative

Secondary Outcomes (2)

  • Investigational Device Performance

    Peroperative

  • Investigational Device Performance

    Peroperative

Study Arms (1)

TAVR procedure with TAVIPILOT (investigational medical device)

EXPERIMENTAL
Device: TAVR using a guidance software

Interventions

TAVR using a guidance softwareDEVICE

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.

TAVR procedure with TAVIPILOT (investigational medical device)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Central Study Contacts

Eric Sejor, MD

CONTACT

0033673335594eric.sejor@caranx-medical.com

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

June 4, 2025

First Posted

June 29, 2025

Study Start

August 1, 2025

Primary Completion

November 30, 2025

Study Completion (Estimated)

May 30, 2026

Last Updated

June 29, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share