NCT07152574

Brief Summary

The TAVIPILOT tele-operated robot by Caranx Medical is an advanced intraoperative robotic assistance system designed to enhance the precision of transcatheter aortic valve positioning during TAVR. The system integrates with standard procedural workflows and enables remote manipulation of delivery system components, allowing for controlled, stable, and reproducible movements. TAVIPILOT facilitates accurate valve alignment and deployment, reducing operator variability. The robot is compatible with approved balloon-expandable transcatheter heart valves (Sapien 3 and Ultra, Edwards Lifesciences, USA) and standard catheterization lab infrastructure.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 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

First Submitted

Initial submission to the registry

August 26, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 3, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2026

Completed
Last Updated

September 3, 2025

Status Verified

August 1, 2025

Enrollment Period

2 months

First QC Date

August 26, 2025

Last Update Submit

August 26, 2025

Conditions

TAVI(Transcatheter Aortic Valve Implantation)

Outcome Measures

Primary Outcomes (2)

  • Investigational Device Safety

    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 and investigational device-related trauma during progression through the ascending aorta and the native valve.

    Periprocedural

  • Investigational Device Safety

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

    Periprocedural

Secondary Outcomes (1)

  • Device Usability

    Periprocedural

Study Arms (1)

Use of tele-operated TAVIPILOT Robot during the procedure

EXPERIMENTAL
Device: TAVR using a tele-operated Robot

Interventions

TAVR using a tele-operated RobotDEVICE

TAVR procedure with TAVIPILOT tele-operated robot by Caranx Medical enhancing the precision of transcatheter aortic valve positioning during TAVR.

Use of tele-operated TAVIPILOT Robot during the procedure

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

Central Study Contacts

Eric Sejor, MD

CONTACT

09 82 24 85 61eric.sejor@caranx-medical.com

Christophe Naz

CONTACT

christophe.naz.pro@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2025

First Posted

September 3, 2025

Study Start

September 15, 2025

Primary Completion

November 15, 2025

Study Completion

February 15, 2026

Last Updated

September 3, 2025

Record last verified: 2025-08