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ROTAO 1 - Feasibility and Safety of the TAVIPILOT Tele-operated Robot During Transcatheter Aortic Valve Replacement (TAVR/TAVI)

NCT ID: NCT07152574

Last Updated: 2025-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-15

Study Completion Date

2026-02-15

Brief Summary

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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.

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Detailed Description

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Conditions

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TAVI(Transcatheter Aortic Valve Implantation)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Use of tele-operated TAVIPILOT Robot during the procedure

Group Type EXPERIMENTAL

TAVR using a tele-operated Robot

Intervention Type DEVICE

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

Interventions

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TAVR using a tele-operated Robot

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Caranx Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Eric Sejor, MD

Role: CONTACT

[email protected]
09 82 24 85 61 ext. +33

Christophe Naz

Role: CONTACT

[email protected]

Other Identifiers

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55005

Identifier Type: -

Identifier Source: org_study_id

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