Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-29 @ 12:46 AM
Study NCT ID:
NCT01361295
Status:
COMPLETED
Last Update Posted:
2020-09-02
First Post:
2011-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerebral Embolism (CE) in Catheter Ablation of Atrial Fibrillation (AF)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D020766', 'term': 'Intracranial Embolism'}], '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'}, {'id': 'D002542', 'term': 'Intracranial Embolism and Thrombosis'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-01', 'studyFirstSubmitDate': '2011-05-20', 'studyFirstSubmitQcDate': '2011-05-25', 'lastUpdatePostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cerebral embolism', 'timeFrame': 'Between 24 hours before the ablation and 24 hours after the ablation', 'description': 'Cerebral embolism will be documented with diffusion weighted MRI of the brain before and after ablation.'}], 'secondaryOutcomes': [{'measure': 'Neuropsychological functioning', 'timeFrame': 'Between a week before the ablation until 3 months after the ablation', 'description': 'A decrease in neuropsychological functioning will be assessed with a questionnaire before and after the procedure'}, {'measure': 'Rise in procoagulation', 'timeFrame': 'Between 24 hours before the ablation and 24 hours after the ablation', 'description': 'The procoagulant state will be assessed before, during and after the procedure by measurement of markers of endothelial damage, markers of activated coagulation, markers of fibrinolysis and by measurement of APTT, PT-INR, fibrinogen and thrombin generation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Atrial fibrillation', 'cerebral embolism', 'catheter ablation'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '19549035', 'type': 'BACKGROUND', 'citation': 'Sauren LD, VAN Belle Y, DE Roy L, Pison L, LA Meir M, VAN DER Veen FH, Crijns HJ, Jordaens L, Mess WH, Maessen JG. Transcranial measurement of cerebral microembolic signals during endocardial pulmonary vein isolation: comparison of three different ablation techniques. J Cardiovasc Electrophysiol. 2009 Oct;20(10):1102-7. doi: 10.1111/j.1540-8167.2009.01509.x. Epub 2009 Jun 22.'}, {'pmid': '19933517', 'type': 'BACKGROUND', 'citation': 'Schrickel JW, Lickfett L, Lewalter T, Mittman-Braun E, Selbach S, Strach K, Nahle CP, Schwab JO, Linhart M, Andrie R, Nickenig G, Sommer T. Incidence and predictors of silent cerebral embolism during pulmonary vein catheter ablation for atrial fibrillation. Europace. 2010 Jan;12(1):52-7. doi: 10.1093/europace/eup350.'}, {'pmid': '15133367', 'type': 'BACKGROUND', 'citation': 'Bulava A, Slavik L, Fiala M, Heinc P, Skvarilova M, Lukl J, Krcova V, Indrak K. Endothelial damage and activation of the hemostatic system during radiofrequency catheter isolation of pulmonary veins. J Interv Card Electrophysiol. 2004 Jun;10(3):271-9. doi: 10.1023/B:JICE.0000026924.96281.be.'}, {'pmid': '30898234', 'type': 'DERIVED', 'citation': 'Kece F, Bruggemans EF, de Riva M, Alizadeh Dehnavi R, Wijnmaalen AP, Meulman TJ, Brugman JA, Rooijmans AM, van Buchem MA, Middelkoop HA, Eikenboom J, Schalij MJ, Zeppenfeld K, Trines SA. Incidence and Clinical Significance of Cerebral Embolism During Atrial Fibrillation Ablation With Duty-Cycled Phased-Radiofrequency Versus Cooled-Radiofrequency: A Randomized Controlled Trial. JACC Clin Electrophysiol. 2019 Mar;5(3):318-326. doi: 10.1016/j.jacep.2018.11.008. Epub 2018 Dec 26.'}]}, 'descriptionModule': {'briefSummary': 'Radiofrequency catheter ablation of atrial fibrillation (AF) induces a procoagulant state, which leads to an acute risk for symptomatic cerebral embolism (CE) of approximately 1%. The induction of a procoagulant state has been studied in pulmonary vein isolation (PVI) with a non-cooled tip catheter. The induction of a procoagulant state using a cooled-tip catheter has not been studied yet. Due to the avoidance of high endocardial temperatures, it can be expected that these procedures induce a lower level of procoagulation.\n\nRecent studies showed an 11% incidence of CE on diffusion weighted (DW) MRI in patients undergoing cooled-tip catheter ablation of AF. In this study there will be used to different catheters, the cooled-tip catheter and the PVAC Gold catheter. Since the PVAC Gold catheter is equipped with non-cooled electrodes, the risk of endothelial scarring, local thrombosis and CE may be increased.\n\nThe goal of this study is to determine the effect of two different ablation catheters on the induction of a procoagulant state and the incidence of CE on DW-MRI in patients with AF undergoing PVI.\n\nOur hypothesis is that patients with AF undergoing PVI using the PVAC gold catheter will show a higher rise in procoagulation and a higher incidence of CE on DW-MRI than patients with AF undergoing PVI with the cooled-tip catheter.', 'detailedDescription': 'A total of 70 patients scheduled for a first ablation of paroxysmal AF will be included. Patients will be 1:1 randomized to PVI using the PVAC gold catheter or the cooled-tip catheter. A control group of 20 patients with AF but without undergoing ablation is included for neuropsychological testing.\n\nBefore the procedure, the procoagulant state will be assessed by measuring several markers of endothelial damage, activated coagulation, fibrinolysis and by measurement of fibrinogen and thrombin generation. Measurements will be repeated during and after the procedure.\n\nDocumentation of the formation of CE will be established by performing a DW-MRI before and after the ablation. The proportion of symptomatic CE will be quantified by neuropsychological tests and questionnaires.\n\nFinally, transcranial doppler will be performed during the entire procedure to quantify the number and pattern of cerebral microembolic signals (MES).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* suffering from drug-refractory paroxysmal atrial fibrillation\n* scheduled for first ablation procedure\n\nExclusion Criteria:\n\n* contra-indications for DW-MRI\n* previous AF-ablation\n* minors\n* any patient unable to undergo neuropsychological testing due to mental retardation'}, 'identificationModule': {'nctId': 'NCT01361295', 'acronym': 'CE-AF', 'briefTitle': 'Cerebral Embolism (CE) in Catheter Ablation of Atrial Fibrillation (AF)', 'organization': {'class': 'OTHER', 'fullName': 'Leiden University Medical Center'}, 'officialTitle': 'The Occurrence of Cerebral Embolism (CE) in Catheter Ablation of Atrial Fibrillation (AF) Using Two Different Ablation Catheters', 'orgStudyIdInfo': {'id': 'CE-AF-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PVI with PVAC gold', 'description': 'Patient for pulmonal vein isolation using the PVAC Gold Catheter. Intervention.', 'interventionNames': ['Procedure: PVI with Cooled-RF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PVI with Cooled-RF', 'description': 'Patient for pulmonal vein isolation using the Cooled-RF catheter.', 'interventionNames': ['Procedure: PVI with PVAC gold']}], 'interventions': [{'name': 'PVI with PVAC gold', 'type': 'PROCEDURE', 'otherNames': ['Medtronic AF solutions'], 'description': 'Pulmonary vein isolation using the Medtronic PVAC gold catheter', 'armGroupLabels': ['PVI with Cooled-RF']}, {'name': 'PVI with Cooled-RF', 'type': 'PROCEDURE', 'otherNames': ['CARTO3 system'], 'description': 'Pulmonary vein isolation using the Biosense Webster Navistar Thermocool catheter', 'armGroupLabels': ['PVI with PVAC gold']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leiden', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}], 'overallOfficials': [{'name': 'Serge A. Trines, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiology, LUMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Serge A. Trines', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior cardiologist', 'investigatorFullName': 'Serge A. Trines', 'investigatorAffiliation': 'Leiden University Medical Center'}}}}