Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
130 participants
INTERVENTIONAL
2024-05-31
2026-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Experimental group
Subjects will undergo planned intracardiac interventional procedures utilizing the Arch EchoTM Intracardiac Ultrasound catheter and combined ultrasound system.
Arch EchoTM Intracardiac Ultrasound catheter and ultrasound system
Novel ICE catheter and combined ultrasound system
Control group
Subjects will undergo planned intracardiac interventional procedures utilizing the SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system.
SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system
Commercially available devices
Interventions
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Arch EchoTM Intracardiac Ultrasound catheter and ultrasound system
Novel ICE catheter and combined ultrasound system
SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system
Commercially available devices
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
90 Years
ALL
No
Sponsors
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ICE Intelligent Healthcare Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Deyong Long, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Beijing Anzhen Hospital
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Songwen Chen, MD, PhD
Role: primary
Other Identifiers
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INTELICE-CTP-2401
Identifier Type: -
Identifier Source: org_study_id
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