Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-29 @ 4:51 AM
Study NCT ID:
NCT01229306
Status:
UNKNOWN
Last Update Posted:
2013-05-03
First Post:
2010-10-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Repeat Ablation Procedure in Patients With Relapse of 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-05-02', 'studyFirstSubmitDate': '2010-10-26', 'studyFirstSubmitQcDate': '2010-10-26', 'lastUpdatePostDateStruct': {'date': '2013-05-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom of atrial arrhythmias'}], 'secondaryOutcomes': [{'measure': 'Quality of life, number of reconnected pulmonary veins, safety'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ablation', 'Paroxysmal Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Catheter ablation with isolation of the pulmonary veins has proven to be an effective treatment option in patients with paroxysmal atrial fibrillation. In patients who have a relapse of paroxysmal atrial fibrillation after one ablation procedure the investigators compare the reisolation of all pulmonary veins to reisolation plus an anterior left atrial line.', 'detailedDescription': 'Catheter ablation with isolation of the pulmonary veins has proven to be an effective treatment option in patients with paroxysmal atrial fibrillation. In patients who have a relapse of paroxysmal atrial fibrillation after one ablation procedure we compare the reisolation of all pulmonary veins to reisolation plus an anterior left atrial line.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* relapse of atrial fibrillation\n\nExclusion Criteria:\n\n* contraindication for ablation'}, 'identificationModule': {'nctId': 'NCT01229306', 'briefTitle': 'Repeat Ablation Procedure in Patients With Relapse of Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Deutsches Herzzentrum Muenchen'}, 'officialTitle': 'Repeat Ablation Procedure in Patients With Relapse of Paroxysmal Atrial Fibrillation Using Reisolation of Pulmonary Vein Versus Reisolation of Pulmonary Vein With Additional Anterior Line', 'orgStudyIdInfo': {'id': 'GER-EP-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'reisolation of all PV and additional anterior line', 'interventionNames': ['Procedure: Ablation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'reisolation of all pulmonary veins', 'interventionNames': ['Procedure: Ablation']}], 'interventions': [{'name': 'Ablation', 'type': 'PROCEDURE', 'description': 'Ablation of atrial fibrillation', 'armGroupLabels': ['reisolation of all PV and additional anterior line', 'reisolation of all pulmonary veins']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80636', 'city': 'München', 'state': 'Bayer', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Isabel Deisenhofer, MD', 'role': 'CONTACT', 'email': 'deisenhofer@dhm.mhn.de', 'phone': '+49891218', 'phoneExt': '4596'}, {'name': 'Stephanie Fichtner, MD', 'role': 'CONTACT', 'email': 'fichtner@dhm.mhn.de', 'phone': '+49891218', 'phoneExt': '4596'}, {'name': 'Isabel Deisenhofer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Deutsches Herzzentrum', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Deutsches Herzzentrum Muenchen', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Deutsches Herzzentrum München', 'oldOrganization': 'Abteilung Elektrophysiologie'}}}}