Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-02-22 @ 7:05 AM
Study NCT ID:
NCT02059369
Status:
COMPLETED
Last Update Posted:
2017-04-11
First Post:
2013-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ablation of Complex Fractionated Electrograms With or Without Additional Linear Lesions for Persistent Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D012008', 'term': 'Recurrence'}], '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': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-10', 'studyFirstSubmitDate': '2013-05-23', 'studyFirstSubmitQcDate': '2014-02-07', 'lastUpdatePostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom from atrial arrhythmia', 'timeFrame': '12 months', 'description': 'Documented freedom from atrial arrhythmia (AF or AT) recurrence'}], 'secondaryOutcomes': [{'measure': 'Procedural and safety data', 'timeFrame': '12 months', 'description': 'Duration of procedure, ablation time, fluoroscopy time and complications'}, {'measure': 'Number and result of reablation procedure', 'timeFrame': '12 months', 'description': 'Number of redo procedures, results and type of recurrent arrhythmia'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atrial fibrillation', 'Recurrence', 'CFAE', 'linear ablation'], 'conditions': ['Atrial Fibrillation', 'Recurrence']}, 'descriptionModule': {'briefSummary': 'While there is a consensus to perform pulmonary vein isolation (PVI) as a cornerstone for paroxysmal and persistent atrial fibrillation (AF), different additional ablation approaches are used for substrate modification: linear lesions, ablation of complex fractionated atrial electrograms (CFAE) or a combination of both. The aim of this study is to determine whether there is a difference in terms of freedom from arrhythmia recurrence between PVI with CFAE ablation in combination or not with linear lesions in patients with persistent AF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with symptomatic persistent AF\n* After PVI +CFAE ablation, no termination into sinusrhythm or atrial tachycardia\n\nExclusion Criteria:\n\n* Left atrial thrombus'}, 'identificationModule': {'nctId': 'NCT02059369', 'acronym': 'ADLINE', 'briefTitle': 'Ablation of Complex Fractionated Electrograms With or Without Additional Linear Lesions for Persistent Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Deutsches Herzzentrum Muenchen'}, 'officialTitle': 'Ablation of Complex Fractionated Electrograms With or Without Additional Linear Lesions for Persistent Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'GER-EP-013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CFAE ablation', 'description': 'Intervention: Complex fractionated atrial electrograms (CFAE) Ablation', 'interventionNames': ['Procedure: PVI+CFAE+DCC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CFAE + Lines', 'description': 'CFAE Ablation followed by linear lesions (anterior and Roof line)', 'interventionNames': ['Procedure: PVI, CFAE, anterior and roof line, DCC']}], 'interventions': [{'name': 'PVI+CFAE+DCC', 'type': 'PROCEDURE', 'description': 'pulmonary vein Isolation (PVI), CFAE for substrate modification and direct current cardioversion (DCC) if AF persists', 'armGroupLabels': ['CFAE ablation']}, {'name': 'PVI, CFAE, anterior and roof line, DCC', 'type': 'PROCEDURE', 'description': 'PVI, CFAE ablation. If AF persists linear lesions (anterior and roof line), cardioversion if AF persists', 'armGroupLabels': ['CFAE + Lines']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80636', 'city': 'Munich', 'country': 'Germany', 'facility': 'Deutsches Herzzentrum München', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Deutsches Herzzentrum Muenchen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}