Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-29 @ 6:06 PM
Study NCT ID:
NCT04950192
Status:
COMPLETED
Last Update Posted:
2025-01-06
First Post:
2021-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Philips Intracardiac Echocardiography (ICE) Clinical Registry
Sponsor:
Organization:
Raw JSON
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Notwithstanding the foregoing or in the event such multicenter publication is not submitted within twelve (12) months of completion of the Study at all sites or if Sponsor confirms there will be no multicenter publication, Principal Investigator shall furnish Sponsor with a copy of any proposed publication or presentation at least forty-five (45) days', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': "Each subject's adverse event data were collected up to discharge or within 48 hours post procedure", 'description': 'Adverse event reporting does not differ from clinicaltrials.gov', 'eventGroups': [{'id': 'EG000', 'title': 'Prospective Observational', 'description': 'Prospective observational subjects undergoing planned cardiac procedures utilizing image guidance\n\nICE Image guidance: ICE image guidance will be used on all patients undergoing planned cardiac catheterization procedures', 'otherNumAtRisk': 155, 'deathsNumAtRisk': 155, 'otherNumAffected': 0, 'seriousNumAtRisk': 155, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Technical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Prospective Observational', 'description': 'Prospective observational subjects undergoing planned cardiac procedures utilizing image guidance\n\nICE Image guidance: ICE image guidance will be used on all patients undergoing planned cardiac catheterization procedures'}], 'classes': [{'categories': [{'measurements': [{'value': '153', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During procedure', 'description': "Investigator's assessment (Y/N) on successful delivery of VeriSight to the target intracardiac position and sustained device operation during the procedure", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Imaging Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Prospective Observational', 'description': 'Prospective observational subjects undergoing planned cardiac procedures utilizing image guidance\n\nICE Image guidance: ICE image guidance will be used on all patients undergoing planned cardiac catheterization procedures'}], 'classes': [{'categories': [{'measurements': [{'value': '147', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During procedure', 'description': 'Adequate image quality via Likert scale ( Acceptable or better) as determined by the investigator', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Clinical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Prospective Observational', 'description': 'Prospective observational subjects undergoing planned cardiac procedures utilizing image guidance\n\nICE Image guidance: ICE image guidance will be used on all patients undergoing planned cardiac catheterization procedures'}], 'classes': [{'categories': [{'measurements': [{'value': '149', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During procedure', 'description': "Investigator's assessment (Y/N) on adequacy of VeriSight imaging for visualization of major cardiac structures, and guiding procedural intervention, and ability to detect/ assess intra-procedural complications.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Device-related Adverse Event Detection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Prospective Observational', 'description': 'Prospective observational subjects undergoing planned cardiac procedures utilizing image guidance\n\nICE Image guidance: ICE image guidance will be used on all patients undergoing planned cardiac catheterization procedures'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Procedure through 48 hours or discharge, whichever is earlier', 'description': 'Detect device-related adverse events periprocedural through discharge or ≤48 hours post-procedure, whichever is earlier.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Prospective Observational', 'description': 'Prospective observational subjects undergoing planned cardiac procedures utilizing image guidance\n\nICE Image guidance: ICE image guidance will be used on all patients undergoing planned cardiac catheterization procedures'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '155'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '155'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Prospective Observational', 'description': 'Prospective observational subjects undergoing planned cardiac procedures utilizing image guidance\n\nICE Image guidance: ICE image guidance will be used on all patients undergoing planned cardiac catheterization procedures'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '52', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '103', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.1', 'spread': '14.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '67', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '88', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '125', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '112', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '155', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-24', 'size': 907716, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-03-20T12:46', 'hasProtocol': True}, {'date': '2022-09-02', 'size': 551704, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-03-20T12:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 155}, 'targetDuration': '2 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-18', 'studyFirstSubmitDate': '2021-06-25', 'resultsFirstSubmitDate': '2024-03-21', 'studyFirstSubmitQcDate': '2021-06-25', 'lastUpdatePostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-18', 'studyFirstPostDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical Success', 'timeFrame': 'During procedure', 'description': "Investigator's assessment (Y/N) on successful delivery of VeriSight to the target intracardiac position and sustained device operation during the procedure"}, {'measure': 'Imaging Success', 'timeFrame': 'During procedure', 'description': 'Adequate image quality via Likert scale ( Acceptable or better) as determined by the investigator'}, {'measure': 'Clinical Success', 'timeFrame': 'During procedure', 'description': "Investigator's assessment (Y/N) on adequacy of VeriSight imaging for visualization of major cardiac structures, and guiding procedural intervention, and ability to detect/ assess intra-procedural complications."}, {'measure': 'Number of Participants With Device-related Adverse Event Detection', 'timeFrame': 'Procedure through 48 hours or discharge, whichever is earlier', 'description': 'Detect device-related adverse events periprocedural through discharge or ≤48 hours post-procedure, whichever is earlier.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['ICE', 'Image guided therapy', 'Structural Heart', 'Electrophysiology', 'Intracardiac echocardiography', 'Atrial Fibrillation', 'Stroke', 'Ablation', 'Valve Disease'], 'conditions': ['Atrial Fibrillation', 'Stroke', 'Valve Disease, Heart', 'Atrial Septal Defect', 'Patent Foramen Ovale', 'Mitral Valve Disease', 'Tricuspid Valve Disease', 'Aortic Valve Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this observational registry is to report real-world safety and performance of VeriSight for ultrasound guided ICE imaging in percutaneous cardiac intervention procedures when used in standard clinical practice.', 'detailedDescription': 'This is a prospective, multi-center, observational, single-arm registry intended to gather real-world data to report VeriSight ICE catheter performance and safety. It will be conducted in the United States under the approval of one or more recognized institutional review boards and in compliance with Good Clinical Practice guidelines defined in International Standards Organization:14155;2011, the Declaration of Helsinki, and all applicable federal and local laws and regulations. Only on label uses of the VeriSight ICE catheter will be allowed. No specific claims are being validated during this registry, though data analyzed from this protocol are intended to inform of future claims regarding the performance and safety of the VeriSight catheter.\n\nEnrolled patients will be imaged with VeriSight for various types of percutaneous cardiac interventional procedures. Enrolled subjects will be followed until discharge or ≤48 hrs post-procedure. The registry has a planned duration of approximately 24-36 months with interim analysis planned at 100 patients before further enrollment will be considered. Statistical hypotheses are not intended for this registry and descriptive analysis will be conducted. Data from all clinical sites are intended to be pooled for analysis. It is possible that sub-analyses may be conducted to demonstrate VeriSight guidance for target intervention types in structural heart and electrophysiology procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All subjects age 18 and older that are scheduled for and will undergo a planned cardiac interventional percutaneous procedure in which the guidance of ICE is indicated, eligible and willing to sign an informed consent without meeting any of the exclusion criteria set and meeting all the inclusion criteria set forth in the protocol will be included in the population for analyses.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 years of age and willing to provide written, dated and signed, informed consent\n2. Scheduled for a procedure that is within the scope of clinical indication for VeriSight per Instructions for Use (IFU)\n\nExclusion Criteria:\n\n1. Contraindicated for ICE catheter placement or patient considerations that make placement of VeriSight not technically feasible\n2. If alternate access (as needed instead of femoral) is not viable\n3. Known contraindicated conditions include sepsis, major coagulation abnormalities, presence of any intracardiac thrombus, presence of class IV angina or heart failure, deep vein thrombosis, or significant peripheral vascular disease.'}, 'identificationModule': {'nctId': 'NCT04950192', 'briefTitle': 'Philips Intracardiac Echocardiography (ICE) Clinical Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philips Clinical & Medical Affairs Global'}, 'officialTitle': 'The Philips (VeriSight) Intracardiac Echocardiography (ICE) Registry', 'orgStudyIdInfo': {'id': '2019_10745'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prospective Observational', 'description': 'Prospective observational subjects undergoing planned cardiac procedures utilizing image guidance', 'interventionNames': ['Device: ICE Image guidance']}], 'interventions': [{'name': 'ICE Image guidance', 'type': 'DEVICE', 'otherNames': ['Philips VeriSight ICE Catheter'], 'description': 'ICE image guidance will be used on all patients undergoing planned cardiac catheterization procedures', 'armGroupLabels': ['Prospective Observational']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '60208', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Cardiac Arrhythmia Research Foundation', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Rashmi Ram, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Philips Clinical and Medical Affairs'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philips Clinical & Medical Affairs Global', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}