Autonomous Robotics for Transcatheter Cardiac Procedures

Completed

• Conditions: Heart Valve Diseases; Mitral Valve Disease; Structural Heart Abnormality
• Interventions: Procedure: Percutaneous cardiac procedure

• Registration Number: NCT04787757
• Lead Sponsor: Università Vita-Salute San Raffaele

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-26
• Study First Submitted QC: 2021-03-04
• Study First Posted: 2021-03-09
• Study Start: 2021-03-15
• Primary Completion: 2024-05-21
• Study Completion: 2024-06-21
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 401

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Percutaneous cardiac procedures	Percutaneous cardiac procedure	Patients undergoing percutaneous cardiac procedures

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Università Vita-Salute San Raffaele; 🇮🇹 Milano, MI, Italy