NCT07664163

Brief Summary

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

Trial Health

77
On Track

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
7mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
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 Progress11%
Sep 2026May 2027

First Submitted

Initial submission to the registry

February 3, 2026

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

September 10, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

September 9, 2026

Status Verified

September 1, 2026

Enrollment Period

3 months

First QC Date

February 3, 2026

Last Update Submit

September 4, 2026

Conditions

TAVI(Transcatheter Aortic Valve Implantation)

Outcome Measures

Primary Outcomes (2)

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

    Investigational Device Safety

    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 and investigational device-related.

    Investigational device-related safety

    Periprocedural

Secondary Outcomes (2)

  • Device Performance

    Periprocedural

  • Clinician satisfaction

    Periprocedural

Study Arms (1)

Use of tele-operated TAVIPILOT Software and Robot during the procedure

EXPERIMENTAL

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

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

Interventions

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

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

Use of tele-operated TAVIPILOT Software and 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

Study Sites (2)

Macquarie University Hospital

Sydney, New South Wales, 2109, Australia

RECRUITING

St Vincent's Hospital Sydney

Sydney, New South Wales, Australia

RECRUITING

Central Study Contacts

Dr Eric Sejor

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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2026

First Posted

June 24, 2026

Study Start

September 10, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

September 9, 2026

Record last verified: 2026-09

Locations

AU(2)