Atrial Fibrillation Clinical Trial
Official title:
The Cardiac Intervention Imaging Clinical Trial of an Intracardiac Ultrasound Catheter and Ultrasound System
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.
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. ;
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