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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
130
Novel ICE catheter and combined ultrasound system
Commercially available devices
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
Image quality
The image quality will be assessed by three cardiac sonographers. Sonographers will score based on image parameters such as image clarity, penetration, temporal and spatial resolution, blood flow, etc. The evaluation with utilize a 1-5 scale scoring system. A score of 5 indicates that the images are excellent and suitable for clinical needs, while a score of 4 suggests good quality. 3 indicates that the image has flaws but still meets the clinical needs. Scores of 1 and 2 signify poor or bad image quality, which can affect clinical diagnosis and treatment.
Time frame: Up to 6 months
Image quality
Adequate image quality will be assessed by the operators using the same evaluation criteria as the sonographers. However, the operator's responses are simplified and not encompass all different modes of ultrasound.
Time frame: Up to 48 hours
Procedure success
Interventional procedure success rate.
Time frame: Up to 24 hours
Technical success
Success delivery of ICE catheters to the target position. The operator aims to visualize a particular heart structure and requires the ICE catheter to be positioned at a specific site, such as the right atrium, right ventricular including outflow tract or left atrium, etc. The determination of whether the catheter has been successfully delivered to target locations is made by the operators.
Time frame: Up to 24 hours
Procedure time
The time from vascular puncture to completion.
Time frame: Up to 24 hours
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