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NOT YET RECRUITING
NCT06344494
NA

Cardiac Interventional ICE Imaging Trial

Sponsor: ICE Intelligent Healthcare Co., Ltd

View on ClinicalTrials.gov

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

Interventions

DEVICE

Arch EchoTM Intracardiac Ultrasound catheter and ultrasound system

Novel ICE catheter and combined ultrasound system

DEVICE

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