Structural Heart DiseasesINTELICENCT06344494
Cardiac Interventional ICE Imaging Trial
A study testing Arch EchoTM Intracardiac Ultrasound catheter and ultrasound system and SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system in people with Structural Heart Diseases and Atrial Septal Defect, run by ICE Intelligent Healthcare Co., Ltd at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Structural Heart Diseases, Atrial Septal Defect, Patent Foramen Ovale
- What is being tested?
- Arch EchoTM Intracardiac Ultrasound catheter and ultrasound system and SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 4 sitesChina
- Study dates
- May 2024to May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Requirement for ICE imaging of the heart;
- Requirement for ICE imaging of great vessels;
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Beijing Anzhen Hospital, Capital Medical University
Beijing, Bejing, 100011
Deyong Long, MD, PhD, 64412431 ext. 0086010, dragon2008@vip.sina.com
Ribo Tang, MD, PhD
The First Hospital Of Jilin University
Changchun, Jilin, 130021
Shuyan Li, MD, PhD, 88782222 ext. 00860431, shuyanli1992@163.com
Shuyan Li, MD, PhD
The First People's Hospital of Changzhou
Changzhou, Jiangsu, 213004
Ling Yang, MD, 68873108 ext. 00860519, Yangling369@czfph.com
Ling Yang, MD
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200081
Songwen Chen, MD, PhD, 18017638339 ext. 0086
Songwen Chen, MD, PhD
About this study
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.
Read the 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.
- Conditions
- Structural Heart Diseases, Atrial Septal Defect, Patent Foramen Ovale, Arrhythmias, Cardiac, Atrial Fibrillation, Supraventricular Tachycardia
- Being tested
- Arch EchoTM Intracardiac Ultrasound catheter and ultrasound system, SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system
- Keywords
- Intracardiac echocardiography
- Medical subject headings
- Heart Septal Defects, Atrial, Foramen Ovale, Patent, Arrhythmias, Cardiac, Atrial Fibrillation, Tachycardia, Supraventricular, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arch EchoTM Intracardiac Ultrasound catheter and ultrasound systemDevice
Novel ICE catheter and combined ultrasound system
SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 systemDevice
Commercially available devices
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Subjects will undergo planned intracardiac interventional procedures utilizing the Arch EchoTM Intracardiac Ultrasound catheter and combined ultrasound system. Receives: Device: Arch EchoTM Intracardiac Ultrasound catheter and ultrasound system |
| Control group | Active comparator | Subjects will undergo planned intracardiac interventional procedures utilizing the SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system. Receives: Device: SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months
Secondary outcomes (4)
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.
Measured: Up to 48 hours
Procedure success
Interventional procedure success rate.
Measured: 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.
Measured: Up to 24 hours
Procedure time
The time from vascular puncture to completion.
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study startMay 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Structural Heart DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ICE Intelligent Healthcare Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Deyong Long, MD, PhD, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344494
- Sponsor's protocol ID
- INTELICE-CTP-2401
- Acronym
- INTELICE
- Status last verified
- Mar 2024
- First submitted
- 14 Mar 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cardiac Intervention Imaging Clinical Trial of an Intracardiac Ultrasound Catheter and Ultrasound System
- ClinicalTrials.gov ID
- NCT06344494
- Acronym / sponsor ID
- INTELICE / INTELICE-CTP-2401
- Conditions
- Structural Heart Diseases, Atrial Septal Defect, Patent Foramen Ovale, Arrhythmias, Cardiac, Atrial Fibrillation, Supraventricular Tachycardia
- Keywords
- Intracardiac echocardiography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- ICE Intelligent Healthcare Co., LtdIndustry (pharma, biotech, devices)
- Study start
- May 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Arch EchoTM Intracardiac Ultrasound catheter and ultrasound systemSubjects will undergo planned intracardiac interventional procedures utilizing the Arch EchoTM Intracardiac Ultrasound catheter and combined ultrasound system. |
| Control group | Active comparator | Device: SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 systemSubjects will undergo planned intracardiac interventional procedures utilizing the SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arch EchoTM Intracardiac Ultrasound catheter and ultrasound systemNovel ICE catheter and combined ultrasound system | Device | Experimental group |
| SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 systemCommercially available devices | Device | Control group |
Primary outcome
Image quality
Time frame: 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.
4 secondary outcomes
Image quality
Time frame: Up to 48 hours
Procedure success
Time frame: Up to 24 hours
Technical success
Time frame: Up to 24 hours
Procedure time
Time frame: Up to 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deyong Long, MD, PhD principal investigator
Beijing Anzhen Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arch EchoTM Intracardiac Ultrasound catheter and ultrasound system and SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system in people with Structural Heart Diseases and Atrial Septal Defect, run by ICE Intelligent Healthcare Co., Ltd at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deyong Long, MD, PhD (64412431 ext. 0086010, dragon2008@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image quality (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.