Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Septal Defect, Patent Foramen Ovale, Structural Heart Diseases, Supraventricular Tachycardia, Valve Disease, Heart
Conditions
Keywords
Intracardiac echocardiography
Brief 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.
Interventions
DEVICEArch EchoTM Intracardiac Ultrasound catheter and ultrasound system
Novel ICE catheter and combined ultrasound system
DEVICESOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system
Commercially available devices
Sponsors
ICE Intelligent Healthcare Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years, ≤90 years, of any gender. * Subjects deemed suitable for the utilization of ICE catheters during cardiac interventional procedures, as determined by investigators: 1. Requirement for ICE imaging of the heart; 2. Requirement for ICE imaging of great vessels; 3. Requirement for ICE imaging of other intracardiac devices. * Subjects themselves or their guardians must possess the ability to comprehend the purpose of this study, demonstrate adequate compliance with the protocol, and sign the informed consent form.
Exclusion criteria
* Anticipated vascular access (e.g., femoral vein, inferior vena cava, subclavian vein, internal jugular vein) cannot meet the procedure needs. * PLT \<100\*109/L or INR \>1.5. * Intracardiac blood clots or severe peripheral vascular disease (e.g., deep vein thrombosis, aneurysm, atherosclerosis). * Sepsis, pyemia, or severe systemic infection. * NYHA Class IV. * History of cardiac or related cardiac areas surgery within 6 months. * Inability to tolerate post procedure oral anticoagulants or antiplatelet drugs. * Inability to tolerate or cooperate with the procedure. * Pregnant or lactating women, women with a positive pregnancy test result within 7 days before enrollment. * Participation in other clinical trials of drugs, biological agents or devices within 3 months before screening. * Other exclusive circumstances determined by the investigators, where the subject is deemed unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Image quality | Up to 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Image quality | Up to 48 hours | 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. |
| Procedure success | Up to 24 hours | Interventional procedure success rate. |
| Technical success | Up to 24 hours | 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. |
| Procedure time | Up to 24 hours | The time from vascular puncture to completion. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Device performance | Up to 24 hours | Device performance evaluation by the investigator. The assessment will primarily focus on catheter parameters including deliverability, deflectability, compatibility, etc. A scoring system will be employed, where 5 points indicate the highest level of satisfaction, 3 points signify meeting the minimum requirements, and 1 or 2 points indicate dissatisfaction. |
Countries
China
Contacts
Primary ContactDeyong Long, MD, PhD
Outcome results
None listed