Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:54 PM
Study NCT ID:
NCT00873067
Status:
COMPLETED
Last Update Posted:
2014-02-27
First Post:
2009-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Benefit of Complex Fractionated Atrial Electrograms Elimination in Atrial Fibrillation 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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-26', 'studyFirstSubmitDate': '2009-03-31', 'studyFirstSubmitQcDate': '2009-03-31', 'lastUpdatePostDateStruct': {'date': '2014-02-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom from atrial arrhythmias without antiarrhythmic drugs', 'timeFrame': '1-year follow-up'}], 'secondaryOutcomes': [{'measure': 'Freedom form atrial arrhythmias with or without antiarrhythmic drugs', 'timeFrame': '1-year follow-up'}, {'measure': 'Presence of any complications in the acute phase or during follow-up', 'timeFrame': '1-year follow-up'}, {'measure': 'Freedom from atypical atria flutter', 'timeFrame': '1-year follow-up'}, {'measure': 'Increase in radioscopy time and radiofrequency application time', 'timeFrame': '1-year follow-up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Atrial fibrillation', 'Complex fractionated electrograms', 'CFAE'], 'conditions': ['Atrial Fibrillation', 'Catheter Ablation']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate whether performing complex fractionated atrial electrograms ablation improves outcomes in persistent or atrial fibrillation ablation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with persistent (more than 7 days, or less than 7 days needing pharmacologic or electric cardioversion)\n* Presence of atrial fibrillation at the beginning of the procedure\n\nExclusion Criteria:\n\n* Hypo or hyperthyroidism\n* Persistent long-lasting or non-defined duration atrial fibrillation\n* Hypertrophic myocardiopathy\n* Implantable defibrillation or pacemaker implanted\n* Moderate or severe mitral valve disease or mitral prosthetic valve\n* Ejection fraction less than 30%\n* Left atrial anteroposterior diameter more than 50 mm.\n* Previous atrial fibrillation ablation\n* Contraindication to anticoagulation\n* Left atrium thrombus\n* Current infective disease or sepsis\n* Pregnant women\n* Current unstable angor\n* Acute myocardial infarction in last 3 months\n* Atrial fibrillation secondary to ionic disturbance, thyroids disease or secondary to any other reversible or non cardiovascular disease\n* Reduced expectancy of life (less than 12 months)\n* Patient participating in another clinical study that investigates a drug or device\n* Psychologically unstable patient or denies to give informed consent\n* Any cause that contraindicate ablation procedure or antiarrhythmic drug'}, 'identificationModule': {'nctId': 'NCT00873067', 'briefTitle': 'Benefit of Complex Fractionated Atrial Electrograms Elimination in Atrial Fibrillation Ablation', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Benefit of Complex Fractionated Atrial Electrograms Elimination in Atrial Fibrillation Ablation', 'orgStudyIdInfo': {'id': 'HCP/08/207-4495-CFAE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ACVP plus roof line', 'description': 'Standard procedure for atrial fibrillation ablation, including pulmonary vein isolation plus roof line ablation. All ablation lines will be tested.', 'interventionNames': ['Procedure: Standard atrial fibrillation ablation procedure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Additional CFAEs ablation', 'description': 'Atrial fibrillation ablation with pulmonary vein ablation and roof line. In addition, complex fractionated atrial electrograms ablation will be performed, lasting at most 30 minutes.', 'interventionNames': ['Procedure: Additional Complex Fractionated Electrograms ablation']}], 'interventions': [{'name': 'Additional Complex Fractionated Electrograms ablation', 'type': 'PROCEDURE', 'otherNames': ['Complex atrial fractionated electrograms ablation'], 'description': 'Atrial fibrillation ablation with pulmonary vein ablation and roof line. In addition, complex fractionated atrial electrograms ablation will be performed, lasting at most 30 minutes.', 'armGroupLabels': ['Additional CFAEs ablation']}, {'name': 'Standard atrial fibrillation ablation procedure', 'type': 'PROCEDURE', 'otherNames': ['ACVP ablation', 'Roof line'], 'description': 'Standard procedure for persistent atrial fibrillation including circumferential pulmonary vein ablation and roof line, both being tested. No other lines or lesions will be performed.', 'armGroupLabels': ['ACVP plus roof line']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic Universitari de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Lluís Mont, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Clinic Universitary de Barcelona'}, {'name': 'Elena Arbelo, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Clínic Universitari de Barcelona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundacio Clinic Barcelona', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Arrhythmia Unit', 'investigatorFullName': 'Josep Lluis Mont Girbau', 'investigatorAffiliation': 'Hospital Clinic of Barcelona'}}}}