NCT06344494

Cardiac Interventional ICE Imaging Trial

The Cardiac Intervention Imaging Clinical Trial of an Intracardiac Ultrasound Catheter and Ultrasound System

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: ICE Intelligent Healthcare Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This randomized controlled trial will enroll adult patients undergoing cardiac interventions, who will be randomly assigned to either the experimental device group or the control group. The main endpoint of the INTELICE trial is the image quality rate of intracardiac echocardiography, which will be evaluated by three experienced sonographers from the core laboratory, while the operator's image quality assessment serves as a secondary endpoint. In addition, secondary endpoints include clinical success rate, technical success rate, procedure time, and evaluation for the experimental devices.

Conditions

• Structural Heart Diseases
• Atrial Septal Defect
• Patent Foramen Ovale
• Arrhythmias, Cardiac
• Atrial Fibrillation
• Supraventricular Tachycardia
• Valve Disease, Heart

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-05-01
• Completion: 2026-05-01
• First posted: 2024-04-03
• Last updated: 2024-04-04

Locations

4 sites across 1 country: China