protocolSection identificationModule nctId: NCT06344494, orgStudyIdInfo id: INTELICE-CTP-2401, briefTitle: Cardiac Interventional ICE Imaging Trial, acronym: INTELICE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: ICE Intelligent Healthcare Co., Ltd, class: INDUSTRY, 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., conditionsModule conditions: Structural Heart Diseases, conditions: Atrial Septal Defect, conditions: Patent Foramen Ovale, conditions: Arrhythmias, Cardiac, conditions: Atrial Fibrillation, conditions: Supraventricular Tachycardia, conditions: Valve Disease, Heart, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: Arch EchoTM Intracardiac Ultrasound catheter and ultrasound system, interventions name: SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system, outcomesModule primaryOutcomes measure: Image quality, secondaryOutcomes measure: Image quality, secondaryOutcomes measure: Procedure success, secondaryOutcomes measure: Technical success, secondaryOutcomes measure: Procedure time, otherOutcomes measure: Device performance, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Anzhen Hospital, Capital Medical University, city: Beijing, state: Bejing, zip: 100011, country: China, contacts name: Deyong Long, MD, PhD, role: CONTACT, phone: 64412431, phoneExt: 0086010, email: dragon2008@vip.sina.com, contacts name: Ribo Tang, MD, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, locations facility: The First People's Hospital of Changzhou, city: Changzhou, state: Jiangsu, zip: 213004, country: China, contacts name: Ling Yang, MD, role: CONTACT, phone: 68873108, phoneExt: 00860519, email: Yangling369@czfph.com, contacts name: Ling Yang, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Bo Qian, MD, role: SUB_INVESTIGATOR, geoPoint lat: 31.77359, lon: 119.95401, locations facility: The First Hospital Of Jilin University, city: Changchun, state: Jilin, zip: 130021, country: China, contacts name: Shuyan Li, MD, PhD, role: CONTACT, phone: 88782222, phoneExt: 00860431, email: shuyanli1992@163.com, contacts name: Shuyan Li, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Hongbo Meng, role: SUB_INVESTIGATOR, geoPoint lat: 43.88, lon: 125.32278, locations facility: Shanghai General Hospital, city: Shanghai, state: Shanghai, zip: 200081, country: China, contacts name: Songwen Chen, MD, PhD, role: CONTACT, phone: 18017638339, phoneExt: 0086, contacts name: Songwen Chen, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Juan Sun, role: SUB_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False