Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-03-04 @ 12:32 PM
Study NCT ID:
NCT01651702
Status:
WITHDRAWN
Last Update Posted:
2017-04-13
First Post:
2012-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Carto Versus Ensite 3D Electroanatomical Mapping Systems for Arrhythmias Ablations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Poor recruit rate', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-12', 'studyFirstSubmitDate': '2012-07-23', 'studyFirstSubmitQcDate': '2012-07-26', 'lastUpdatePostDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedure duration', 'timeFrame': 'Procedure duration - average expected 2.5 hours', 'description': 'Average procedure duration (needle to catheters withdrawal)'}], 'secondaryOutcomes': [{'measure': 'Fluoroscopy time', 'timeFrame': 'Procedures will be evaluated for the fluoro time, expected average 30 min', 'description': 'Average fluro time in each of groups.'}, {'measure': 'Procedure success', 'timeFrame': 'Patients will be followed for one year for recurrency of arrhythmia', 'description': 'Recurrency of the arrhythmia assessed by blinded electrophysiologist'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Arrhythmia', 'Electroanatomical mapping'], 'conditions': ['Arrhythmias']}, 'descriptionModule': {'briefSummary': 'Three dimensional anatomical mapping is an established method facilitating ablation of cardiac arrhythmias. The most commonly used systems are CARTO® System (Biosense Webster, Inc., Diamond Bar, CA, USA) and EnSite NavX™ (St. Jude Medical, Inc., St. Paul, MN, USA). These two systems has been compared in only a few studies. Recent technical advances resulted in the development of new versions of both systems. To the best of the investigators knowledge no studies have been performed for direct comparison of the newer versions of these two systems. The aim of the study to compare two systems for the use in the ablation of complex arrhythmias.', 'detailedDescription': "Background:\n\nThree dimensional anatomical mapping is an established method facilitating ablation of cardiac arrhythmias. It is nowadays an excepted method especially for complex arrhythmias such as atrial fibrillation and ventricular tachycardia.\n\nThe most commonly used systems are CARTO® System (Biosense Webster, Inc., Diamond Bar, CA, USA) and EnSite NavX™ (St. Jude Medical, Inc., St. Paul, MN, USA). These mapping systems have helped to decrease procedural complexity, procedure time, and improve safety. The EnSite NavX system uses impedance measurements between the individual catheter electrodes and the patches placed on the patient's chest and abdomen. The CARTO system utilizes magnetic location technology to provide accurate visualization of the magnet sensor-equipped catheter tip.\n\nThese two systems has been compared in only a few studies. Different results have been found in simple ablations versus more complex ablation of atrial fibrillation. Recent technical advances resulted in the development of new versions of both systems. Carto Express version allows quicker mapping and reconstruction of heart cavities and great vessels geometry as compared to previous versions of Carto XP. EnSite Velocity system incorporates more precise catheter visualization, and allows quicker mapping as compared to previous version of EnSite.\n\nTo the best of the investigators knowledge no studies have been performed for direct comparison of the newer versions of these two systems.\n\nStudy design Prospective single-center non-randomized open label comparison study. Primary objective Comparison of Carto Express system vs. EnSite Velocity system for ablation of complex arrhythmias.\n\nEnd points:\n\n1. Procedure duration.\n2. Fluoroscopy time\n3. Procedure success -will be measured in terms of the 1-year recurrent arrhythmia rate Study population Patients planned for ablation of complex arrhythmia."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18- 80.\n2. Ability to sign informed consent.\n3. History of one of the following arrhythmias requiring the use of 3D electroanatomical mapping:\n\n * Symptomatic paroxysmal or persistent atrial fibrillation with failed treatment of at least two anti-arrhythmic drugs.\n * Ischemic ventricular tachycardia necessitating ablation as per decision of electrophysiologist.\n * Symptomatic atrial tachycardia after failed medical treatment.\n * Symptomatic idiopathic ventricular tachycardia.\n\nExclusion Criteria:\n\n1. Unstable patients not allowing performing procedure more than 2 hours\n2. Patients planned for one of the two systems compared for whatever reason Ex. procedure planned with NAVX system Array Balloon).'}, 'identificationModule': {'nctId': 'NCT01651702', 'briefTitle': 'Comparison of Carto Versus Ensite 3D Electroanatomical Mapping Systems for Arrhythmias Ablations', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'Comparative Study of Two 3D Electroanatomical Mapping Systems for Ablations of Different Complex Arrhythmias', 'orgStudyIdInfo': {'id': '0067-12-RMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Carto', 'description': 'Patients in whom Carto system will be used', 'interventionNames': ['Device: Carto']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ensite', 'description': 'Patients in whom Ensite system will be used', 'interventionNames': ['Device: Ensite']}], 'interventions': [{'name': 'Carto', 'type': 'DEVICE', 'description': 'Group of patients where Carto Express system will be used for electroanatomical mapping.', 'armGroupLabels': ['Carto']}, {'name': 'Ensite', 'type': 'DEVICE', 'description': 'Group of patients where Ensite Velocity system will be used for electroanatomical mapping.', 'armGroupLabels': ['Ensite']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gregory Golovchiner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rabin Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Invistigator', 'investigatorFullName': 'Gregory Golovchiner, MD', 'investigatorAffiliation': 'Rabin Medical Center'}}}}