Autonomous Robotics for Transcatheter Cardiac Procedures

NCT ID: NCT04787757

Last Updated: 2025-08-17

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

COMPLETED

Total Enrollment

401 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-15

Study Completion Date

2024-06-21

Brief Summary

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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.

Detailed Description

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Conditions

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Mitral Valve Disease Heart Valve Diseases Structural Heart Abnormality

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Percutaneous cardiac procedures

Patients undergoing percutaneous cardiac procedures

Percutaneous cardiac procedure

Intervention Type PROCEDURE

Collection and analysis of intraprocedural information to provide artificial intelligence algorithms

Interventions

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Percutaneous cardiac procedure

Collection and analysis of intraprocedural information to provide artificial intelligence algorithms

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Politecnico di Milano

OTHER

Sponsor Role collaborator

Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

OTHER

Sponsor Role collaborator

KU Leuven

OTHER

Sponsor Role collaborator

SwissVortex

UNKNOWN

Sponsor Role collaborator

Artiness SRL

INDUSTRY

Sponsor Role collaborator

FBGS

UNKNOWN

Sponsor Role collaborator

IRCCS Ospedale San Raffaele

OTHER

Sponsor Role collaborator

Università Vita-Salute San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Giovanni Landoni

MD, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Università Vita-Salute San Raffaele

Milan, MI, Italy

Site Status

Countries

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Italy

References

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Munafo R, Saitta S, Tondi D, Ingallina G, Denti P, Maisano F, Agricola E, Votta E. Automatic 4D mitral valve segmentation from transesophageal echocardiography: a semi-supervised learning approach. Med Biol Eng Comput. 2025 Jan 11. doi: 10.1007/s11517-024-03275-w. Online ahead of print.

Reference Type BACKGROUND
PMID: 39797996 (View on PubMed)

Other Identifiers

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ARTERY/08/2021

Identifier Type: -

Identifier Source: org_study_id

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