Clincosm LogoSign in Get a demo

ARTERY: Autonomous Robotics for Transcatheter Cardiac Procedures

Sponsor
Università Vita-Salute San Raffaele (Other)
Overall Status
Recruiting
CT.gov ID
NCT04787757
Collaborator
Politecnico di Milano (Other), Scuola Superiore Di Studi Universitari E Di Perfezionamento Sant'Anna (Other), KU Leuven (Other), SwissVortex (Other), Artiness SRL (Industry), FBGS (Other), IRCCS Ospedale San Raffaele (Other)
200
Enrollment
1
Location
35.5
Anticipated Duration (Months)
5.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Percutaneous cardiac procedure

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Autonomous Robotics for Transcatheter dEliveRy sYstems
Actual Study Start Date :
Mar 15, 2021
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Percutaneous cardiac procedures

Patients undergoing percutaneous cardiac procedures

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

Outcome Measures

Primary Outcome Measures

  1. Identification of key procedural elements that will benefit from the technological developments introduced by ARTERY by collecting intraprocedural images [Intraoperative period]

    Number of patients undergoing percutaneous cardiac procedures

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Università Vita-Salute San Raffaele Milano MI Italy 20132

Sponsors and Collaborators

  • Università Vita-Salute San Raffaele
  • Politecnico di Milano
  • Scuola Superiore Di Studi Universitari E Di Perfezionamento Sant'Anna
  • KU Leuven
  • SwissVortex
  • Artiness SRL
  • FBGS
  • IRCCS Ospedale San Raffaele

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Giovanni Landoni, MD, Associate Professor, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier:
NCT04787757
Other Study ID Numbers:
  • ARTERY/08/2021
First Posted:
Mar 9, 2021
Last Update Posted:
Jun 21, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Heart Valve Diseases

Study Results

No Results Posted as of Jun 21, 2022