Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2026-01-01 @ 11:21 AM
Study NCT ID:
NCT00556595
Status:
UNKNOWN
Last Update Posted:
2007-11-12
First Post:
2007-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primary Anatomical Versus Primary Electrophysiological Approach in Circumferential Pulmonary Vein Ablation
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2008-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-11-09', 'studyFirstSubmitDate': '2007-11-09', 'studyFirstSubmitQcDate': '2007-11-09', 'lastUpdatePostDateStruct': {'date': '2007-11-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom from atrial tachyarrhythmias at 6-months follow-up', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Comparison of procedural characteristics (duration, fluoroscopy time, ablation time, ablation energy, complications)', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'paroxysmal', 'symptomatic', 'drug-refractory'], 'conditions': ['Paroxysmal Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '14557355', 'type': 'BACKGROUND', 'citation': 'Oral H, Scharf C, Chugh A, Hall B, Cheung P, Good E, Veerareddy S, Pelosi F Jr, Morady F. Catheter ablation for paroxysmal atrial fibrillation: segmental pulmonary vein ostial ablation versus left atrial ablation. Circulation. 2003 Nov 11;108(19):2355-60. doi: 10.1161/01.CIR.0000095796.45180.88. Epub 2003 Oct 13.'}, {'pmid': '17562956', 'type': 'BACKGROUND', 'citation': 'Arentz T, Weber R, Burkle G, Herrera C, Blum T, Stockinger J, Minners J, Neumann FJ, Kalusche D. Small or large isolation areas around the pulmonary veins for the treatment of atrial fibrillation? Results from a prospective randomized study. Circulation. 2007 Jun 19;115(24):3057-63. doi: 10.1161/CIRCULATIONAHA.107.690578. Epub 2007 Jun 11.'}, {'pmid': '15927974', 'type': 'BACKGROUND', 'citation': 'Karch MR, Zrenner B, Deisenhofer I, Schreieck J, Ndrepepa G, Dong J, Lamprecht K, Barthel P, Luciani E, Schomig A, Schmitt C. Freedom from atrial tachyarrhythmias after catheter ablation of atrial fibrillation: a randomized comparison between 2 current ablation strategies. Circulation. 2005 Jun 7;111(22):2875-80. doi: 10.1161/CIRCULATIONAHA.104.491530. Epub 2005 May 31.'}]}, 'descriptionModule': {'briefSummary': 'Randomized comparison between 2 techniques of circumferential pulmonary vein ablation in paroxysmal atrial fibrillation: Primary anatomical ablation with secondary closure of possible electrical gaps versus primary electrophysiological ablation at the sites of atrio-venous electrical breakthroughs with secondary circumferential ablation around the pulmonary vein orifice'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* paroxysmal atrial fibrillation\n* age over 18 years\n\nExclusion Criteria:\n\n* persistent atrial fibrillation\n* reversible cause of atrial fibrillation\n* inability to comply with follow-up'}, 'identificationModule': {'nctId': 'NCT00556595', 'acronym': 'CPVA-PAF', 'briefTitle': 'Primary Anatomical Versus Primary Electrophysiological Approach in Circumferential Pulmonary Vein Ablation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bonn'}, 'officialTitle': 'Circumferential Pulmonary Vein Ablation in Paroxysmal Atrial Fibrillation: Randomized Comparison Between a Primary Anatomical Versus a Primary Electrophysiological Approach', 'orgStudyIdInfo': {'id': 'CPVA-PAF'}, 'secondaryIdInfos': [{'id': 'IRB 160/07'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'primary electrophysiological approach', 'interventionNames': ['Procedure: primary electrophysiological approach']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'primary anatomical approach', 'interventionNames': ['Procedure: primary anatomical approach']}], 'interventions': [{'name': 'primary electrophysiological approach', 'type': 'PROCEDURE', 'description': 'primary ablation of atrio-venous breakthrough sites followed by circumferential ablation around pulmonary vein orifice', 'armGroupLabels': ['1']}, {'name': 'primary anatomical approach', 'type': 'PROCEDURE', 'description': 'primary circumferential ablation around the pulmonary vein orifice followed by ablation of possible conduction gaps', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Lars M Lickfett, MD', 'role': 'CONTACT', 'email': 'lars.lickfett@ukb.uni-bonn.de', 'phone': '*49-228-287-16670'}], 'overallOfficials': [{'name': 'Lars M Lickfett, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Bonn, Department of Cardiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bonn', 'class': 'OTHER'}}}}