Heart Valve Diseases Clinical Trial
— ARTERYOfficial title:
Autonomous Robotics for Transcatheter dEliveRy sYstems
Verified date | January 2024 |
Source | Università Vita-Salute San Raffaele |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Università Vita-Salute San Raffaele | Milano | MI |
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 |
Italy,
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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