Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2025-12-25 @ 4:40 PM
Study NCT ID:
NCT00196157
Status:
UNKNOWN
Last Update Posted:
2009-05-29
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Line Versus Spot Ablation in Persistent Atrial Fibrillation
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 116}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2008-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-05-28', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-19', 'lastUpdatePostDateStruct': {'date': '2009-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sinus rhythm in follow-up', 'timeFrame': 'Sinus rhythm in follow-up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'In this randomized study dealing with the ablative treatment of persistent atrial fibrillation, two ablation strategies are compared: a more anatomically guided linear ablation scheme versus an electrophysiological guided focal ablation strategy aiming at the electrical isolating of the pulmonary veins and ablating areas of fragmented intracardiac electrograms thought to maintain atrial fibrillation.', 'detailedDescription': 'This randomized study deals with two different ablative treatment strategies for persistent atrial fibrillation: a more anatomically guided linear ablation scheme with encircling of the ipsilateral pulmonary veins (PV), a left atrial roof line and an anterior line bridging the anterior mitral anulus to the ostium of the left superior PV versus an electrophysiological guided focal ablation strategy aiming at isolating, electrically, the PV and ablating areas of fragmented intracardiac electrograms thought to maintain atrial fibrillation.\n\nBoth ablation approaches contain isolation of the most common source of triggering foci, i.e., the pulmonary veins and additional modification of the substrate maintaining atrial fibrillation.\n\nThe study endpoint is a combined efficacy/safety analysis. Extensive follow-up with three-monthly 7 days holter ECG is provided.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 18 and 80 years\n* symptomatic persistent (\\> 7 days lasting) atrial fibrillation\n* at least one unsuccessful cardioversion or atrial fibrillation relapse in the first 3 months after cardioversion despite antiarrhythmic drug therapy\n* oral anticoagulation (\\> 4 weeks prior to ablation)\n\nExclusion Criteria:\n\n* moderate to severe valvular heart disease\n* congenital heart disease\n* LV-EF \\< 35%\n* reversible cause for atrial fibrillation (e.g., hyperthyreosis)\n* prior left atrial ablation or Maze operation\n* left atrial thrombus'}, 'identificationModule': {'nctId': 'NCT00196157', 'briefTitle': 'Line Versus Spot Ablation in Persistent Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Deutsches Herzzentrum Muenchen'}, 'officialTitle': 'Linear Anatomically Versus Focal Electrophysiologically Guided Substrate Ablation in Patients With Persistent Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'GE IDE No. C00604'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'linear lesions to ablate persistent atrial fibrillation', 'interventionNames': ['Procedure: linear anatomically oriented ablations']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'focal electrophysiologically guided ablations to treat persistent atrial fibrillation', 'interventionNames': ['Procedure: focal electrophysiological oriented ablations']}], 'interventions': [{'name': 'linear anatomically oriented ablations', 'type': 'PROCEDURE', 'description': 'linear lesions to ablate persistent atrial fibrillation', 'armGroupLabels': ['1']}, {'name': 'focal electrophysiological oriented ablations', 'type': 'PROCEDURE', 'description': 'focal electrophysiologically guided ablations to treat persistent atrial fibrillation', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80636', 'city': 'Munich', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Heidi Estner, MD', 'role': 'CONTACT', 'email': 'estner@dhm.mhn.de', 'phone': '0049 89 1218 2020'}, {'name': 'Heidi Estner, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Deutsches Herzzentrum Muenchen', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'centralContacts': [{'name': 'Heidi Estner, MD', 'role': 'CONTACT', 'email': 'estner@dhm.mhn.de', 'phone': '0049 89 1218 2020'}], 'overallOfficials': [{'name': 'Claus Schmitt, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Deutsches Herzzentrum Muenchen'}, {'name': 'Heidi Estner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Deutsches Herzzentrum Muenchen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Deutsches Herzzentrum Muenchen', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. A. Schömig', 'oldOrganization': 'Deutsches Herzzentrum Munich'}}}}