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NCT04787757 Clinical Trial

Autonomous Robotics for Transcatheter Cardiac Procedures

Heart Valve Diseases Clinical Trial

— ARTERY  

Official title:
Autonomous Robotics for Transcatheter dEliveRy sYstems

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04787757
Other study ID # ARTERY/08/2021
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 15, 2021
Est. completion date September 2024

Study information
Verified date January 2024
Source Università Vita-Salute San Raffaele
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Cardiovascular diseases represent the most common cause of death worldwide. Percutaneous approaches with intravascular catheters are pivotal, since they allow to treat patients with high perioperative risks. However, catheter-based treatments require steep learning curves and are characterized by poor ergonomics and exposure to damaging radiation. ARTERY will offer a radiation-free approach based on shared-autonomy robotic catheters, with increased user engagement and easy interaction. Intraprocedural three-dimensional echocardiography as well as computed tomography images obtained during usual clinical practice will provide artificial intelligence algorithms that will turn catheter navigation to a simple task. Optical and electromagnetic sensing techniques will ensure a superior view upon the cardiovascular anatomy and will guide the autonomous catheter upon the interventionist supervision, who will be able to take over control at any instant.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - adult patients - patients admitted to hospital undergoing percutaneous cardiac procedure - patients able to give informed consent Exclusion Criteria: - age <18 years - refuse to give informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Percutaneous cardiac procedure
Collection and analysis of intraprocedural information to provide artificial intelligence algorithms

Locations
Country Name City State
Italy Università Vita-Salute San Raffaele Milano MI

Sponsors (8)
Lead Sponsor Collaborator
Università Vita-Salute San Raffaele Artiness SRL, FBGS, IRCCS Ospedale San Raffaele, KU Leuven, Politecnico di Milano, Scuola Superiore Di Studi Universitari E Di Perfezionamento Sant'Anna, SwissVortex

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Identification of key procedural elements that will benefit from the technological developments introduced by ARTERY by collecting intraprocedural images Number of patients undergoing percutaneous cardiac procedures Intraoperative period
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