Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT00959205
Status:
UNKNOWN
Last Update Posted:
2010-05-20
First Post:
2009-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of CARTO 3D Mapping System Versus Conventional Method in AF and VT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000792', 'term': 'Angiography'}], 'ancestors': [{'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2011-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-05-19', 'studyFirstSubmitDate': '2009-08-13', 'studyFirstSubmitQcDate': '2009-08-13', 'lastUpdatePostDateStruct': {'date': '2010-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fluoroscopic time', 'timeFrame': '24weeks', 'description': 'Total duration of procedure using fluoroscopy on , in minute'}, {'measure': 'Procedural duration', 'timeFrame': '24weeks', 'description': 'Time from after puncture to catheter remover'}], 'secondaryOutcomes': [{'measure': 'Ablation time', 'timeFrame': '24weeks', 'description': 'Time from to Ablation'}, {'measure': 'Procedural Success', 'timeFrame': '24weeks', 'description': 'Achievement of the procedure endpoint for each arrhythmia'}, {'measure': 'Clinical Success', 'timeFrame': '24weeks', 'description': '* 3 months freedom from recurrence of target arrhythmia\n* \\> 6 months freedom from recurrence of target arrhythmia'}, {'measure': 'Radiation dose', 'timeFrame': '24weeks', 'description': 'Calculated dose (in Gray) to the patient as recorded in the laboratory log'}, {'measure': 'Morphology of ablation', 'timeFrame': '24weeks', 'description': 'Number of Gap and the distance from the ostia of the pulmonary veins (In conventional group)'}, {'measure': 'Complications', 'timeFrame': '24weeks', 'description': '* procedure and device related adverse event requiring any intervention to prevent permanent medical intervention\n* Important complications are reported individually'}, {'measure': 'Cost Effectiveness', 'timeFrame': '24weeks'}, {'measure': 'Survival Rate', 'timeFrame': '24weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of electroanatomic imaging compared to conventional method in patients with VT.', 'detailedDescription': 'To evaluate the efficacy and safety of electroanatomic imaging (CARTO) compared to conventional fluoroscopically guided activation mapping (Conventional) method in patients with Atrial Fibrillation and Substrate-dependent Ventricular Tachycardia To evaluate cost-effectiveness of CARTO 3D image system compared to conventional method in the same study subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with AF or substrate-dependent VT\n\nExclusion Criteria:\n\n* administering with anticoagulants'}, 'identificationModule': {'nctId': 'NCT00959205', 'acronym': 'CARTOAF&VT', 'briefTitle': 'The Efficacy and Safety of CARTO 3D Mapping System Versus Conventional Method in AF and VT', 'organization': {'class': 'OTHER', 'fullName': 'Korea University'}, 'officialTitle': 'Phase Ⅳ Study of CARTO 3D Mapping System vs Conventional Method in AF & VT', 'orgStudyIdInfo': {'id': '2009_KU_CARTO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Angiography', 'description': 'Conventional fluoroscopically guided activation mapping', 'interventionNames': ['Device: Angiography']}, {'type': 'EXPERIMENTAL', 'label': 'CARTO 3D', 'description': 'CARTO (3D Electroanatomic imaging)', 'interventionNames': ['Device: CARTO 3D']}], 'interventions': [{'name': 'CARTO 3D', 'type': 'DEVICE', 'description': 'CARTO (3D Electroanatomic imaging)', 'armGroupLabels': ['CARTO 3D']}, {'name': 'Angiography', 'type': 'DEVICE', 'otherNames': ['Celsius'], 'description': 'Conventional fluoroscopically guided activation mapping', 'armGroupLabels': ['Angiography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '136-705', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea medical center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital/Internal Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': "Seoul St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Kim Young-Hoon, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea medical center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Young-Hoon Kim', 'oldOrganization': 'Korea medical center'}}}}