Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-02-28 @ 3:48 AM
Study NCT ID:
NCT06344494
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Interventional ICE Imaging Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006344', 'term': 'Heart Septal Defects, Atrial'}, {'id': 'D054092', 'term': 'Foramen Ovale, Patent'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D013617', 'term': 'Tachycardia, Supraventricular'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}], 'ancestors': [{'id': 'D006343', 'term': 'Heart Septal Defects'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-02', 'studyFirstSubmitDate': '2024-03-14', 'studyFirstSubmitQcDate': '2024-03-27', 'lastUpdatePostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Device performance', 'timeFrame': 'Up to 24 hours', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Image quality', 'timeFrame': 'Up to 6 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Image quality', 'timeFrame': 'Up to 48 hours', 'description': "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."}, {'measure': 'Procedure success', 'timeFrame': 'Up to 24 hours', 'description': 'Interventional procedure success rate.'}, {'measure': 'Technical success', 'timeFrame': 'Up to 24 hours', 'description': '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.'}, {'measure': 'Procedure time', 'timeFrame': 'Up to 24 hours', 'description': 'The time from vascular puncture to completion.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intracardiac echocardiography'], 'conditions': ['Structural Heart Diseases', 'Atrial Septal Defect', 'Patent Foramen Ovale', 'Arrhythmias, Cardiac', 'Atrial Fibrillation', 'Supraventricular Tachycardia', 'Valve Disease, Heart']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years, ≤90 years, of any gender.\n* Subjects deemed suitable for the utilization of ICE catheters during cardiac interventional procedures, as determined by investigators:\n\n 1. Requirement for ICE imaging of the heart;\n 2. Requirement for ICE imaging of great vessels;\n 3. Requirement for ICE imaging of other intracardiac devices.\n* 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.\n\nExclusion Criteria:\n\n* Anticipated vascular access (e.g., femoral vein, inferior vena cava, subclavian vein, internal jugular vein) cannot meet the procedure needs.\n* PLT \\<100\\*109/L or INR \\>1.5.\n* Intracardiac blood clots or severe peripheral vascular disease (e.g., deep vein thrombosis, aneurysm, atherosclerosis).\n* Sepsis, pyemia, or severe systemic infection.\n* NYHA Class IV.\n* History of cardiac or related cardiac areas surgery within 6 months.\n* Inability to tolerate post procedure oral anticoagulants or antiplatelet drugs.\n* Inability to tolerate or cooperate with the procedure.\n* Pregnant or lactating women, women with a positive pregnancy test result within 7 days before enrollment.\n* Participation in other clinical trials of drugs, biological agents or devices within 3 months before screening.\n* Other exclusive circumstances determined by the investigators, where the subject is deemed unsuitable for enrollment.'}, 'identificationModule': {'nctId': 'NCT06344494', 'acronym': 'INTELICE', 'briefTitle': 'Cardiac Interventional ICE Imaging Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'ICE Intelligent Healthcare Co., Ltd'}, 'officialTitle': 'The Cardiac Intervention Imaging Clinical Trial of an Intracardiac Ultrasound Catheter and Ultrasound System', 'orgStudyIdInfo': {'id': 'INTELICE-CTP-2401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Subjects will undergo planned intracardiac interventional procedures utilizing the Arch EchoTM Intracardiac Ultrasound catheter and combined ultrasound system.', 'interventionNames': ['Device: Arch EchoTM Intracardiac Ultrasound catheter and ultrasound system']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Subjects will undergo planned intracardiac interventional procedures utilizing the SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system.', 'interventionNames': ['Device: SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system']}], 'interventions': [{'name': 'Arch EchoTM Intracardiac Ultrasound catheter and ultrasound system', 'type': 'DEVICE', 'description': 'Novel ICE catheter and combined ultrasound system', 'armGroupLabels': ['Experimental group']}, {'name': 'SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system', 'type': 'DEVICE', 'description': 'Commercially available devices', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100011', 'city': 'Beijing', 'state': 'Bejing', 'country': 'China', 'contacts': [{'name': 'Deyong Long, MD, PhD', 'role': 'CONTACT', 'email': 'dragon2008@vip.sina.com', 'phone': '64412431', 'phoneExt': '0086010'}, {'name': 'Ribo Tang, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Beijing Anzhen Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '213004', 'city': 'Changzhou', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Ling Yang, MD', 'role': 'CONTACT', 'email': 'Yangling369@czfph.com', 'phone': '68873108', 'phoneExt': '00860519'}, {'name': 'Ling Yang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Bo Qian, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "The First People's Hospital of Changzhou", 'geoPoint': {'lat': 31.77359, 'lon': 119.95401}}, {'zip': '130021', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'contacts': [{'name': 'Shuyan Li, MD, PhD', 'role': 'CONTACT', 'email': 'shuyanli1992@163.com', 'phone': '88782222', 'phoneExt': '00860431'}, {'name': 'Shuyan Li, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hongbo Meng', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The First Hospital Of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '200081', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Songwen Chen, MD, PhD', 'role': 'CONTACT', 'phone': '18017638339', 'phoneExt': '0086'}, {'name': 'Songwen Chen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Juan Sun', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Shanghai General Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Deyong Long, MD, PhD', 'role': 'CONTACT', 'email': 'dragon2008@vip.sina.com', 'phone': '64412431', 'phoneExt': '0086010'}], 'overallOfficials': [{'name': 'Deyong Long, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Anzhen Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ICE Intelligent Healthcare Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}