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Cardiac Interventional ICE Imaging Trial
Sponsor: ICE Intelligent Healthcare Co., Ltd
Summary
The INTELICE trial is a prospective, multicenter, 1:1 randomized controlled non-inferiority study. It aims to compare a novel intracardiac echography (ICE) catheter and combined ultrasound system with existing commercial ones. The evaluation will be conducted on patients undergoing planned intracardiac interventional process.
Official title: The Cardiac Intervention Imaging Clinical Trial of an Intracardiac Ultrasound Catheter and Ultrasound System
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
130
Start Date
2024-05
Completion Date
2026-05
Last Updated
2024-04-04
Healthy Volunteers
No
Conditions
Interventions
Arch EchoTM Intracardiac Ultrasound catheter and ultrasound system
Novel ICE catheter and combined ultrasound system
SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system
Commercially available devices
Locations (4)
Beijing Anzhen Hospital, Capital Medical University
Beijing, Bejing, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
The First Hospital Of Jilin University
Changchun, Jilin, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China