NCT04787757

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
401

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 26, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 9, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

March 15, 2021

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2024

Completed
Last Updated

August 17, 2025

Status Verified

August 1, 2025

Enrollment Period

3.2 years

First QC Date

February 26, 2021

Last Update Submit

August 12, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Percutaneous cardiac procedures

Patients undergoing percutaneous cardiac procedures

Procedure: Percutaneous cardiac procedure

Interventions

Collection and analysis of intraprocedural information to provide artificial intelligence algorithms

Percutaneous cardiac procedures

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Candidates to percutaneous cardiac defects repair

You may qualify if:

  • adult patients
  • patients admitted to hospital undergoing percutaneous cardiac procedure
  • patients able to give informed consent

You may not qualify if:

  • age \<18 years
  • refuse to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università Vita-Salute San Raffaele

Milan, MI, 20132, Italy

Location

Related Publications (1)

  • 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.

    PMID: 39797996BACKGROUND

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Associate Professor

Study Record Dates

First Submitted

February 26, 2021

First Posted

March 9, 2021

Study Start

March 15, 2021

Primary Completion

May 21, 2024

Study Completion

June 21, 2024

Last Updated

August 17, 2025

Record last verified: 2025-08

Locations