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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Subjects will undergo planned intracardiac interventional procedures utilizing the Arch EchoTM Intracardiac Ultrasound catheter and combined ultrasound system. |
|
| Control group | Active Comparator | Subjects will undergo planned intracardiac interventional procedures utilizing the SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arch EchoTM Intracardiac Ultrasound catheter and ultrasound system | Device | Novel ICE catheter and combined ultrasound system |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 48 hours |
| Procedure success |
| Measure | Description | Time Frame |
|---|---|---|
| Device performance | 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. | Up to 24 hours |
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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deyong Long, MD, PhD | Contact | 64412431 | 0086010 | dragon2008@vip.sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Deyong Long, MD, PhD | Beijing Anzhen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University | Beijing | Bejing | 100011 | China |
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| SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system | Device | Commercially available devices |
|
Interventional procedure success rate. |
| 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. | Up to 24 hours |
| Procedure time | The time from vascular puncture to completion. | Up to 24 hours |
| The First People's Hospital of Changzhou | Changzhou | Jiangsu | 213004 | China |
|
| The First Hospital Of Jilin University | Changchun | Jilin | 130021 | China |
|
| Shanghai General Hospital | Shanghai | Shanghai Municipality | 200081 | China |
|
| ID | Term |
|---|---|
| D006344 | Heart Septal Defects, Atrial |
| D054092 | Foramen Ovale, Patent |
| D001145 | Arrhythmias, Cardiac |
| D001281 | Atrial Fibrillation |
| D013617 | Tachycardia, Supraventricular |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013610 | Tachycardia |
| D000075224 | Cardiac Conduction System Disease |
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