Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-29 @ 6:20 PM
Study NCT ID:
NCT00367757
Status:
COMPLETED
Last Update Posted:
2019-01-30
First Post:
2006-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
STAR-AF:Substrate Versus Trigger Ablation for Reduction of Atrial Fibrillation Trial
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': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-28', 'studyFirstSubmitDate': '2006-08-22', 'studyFirstSubmitQcDate': '2006-08-22', 'lastUpdatePostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom from atrial fibrillation at 3 months post-first ablation procedure off antiarrhythmic medications.', 'timeFrame': '3 months'}, {'measure': 'Freedom from atrial fibrillation at 6 and 12 months post-first ablation procedure off antiarrhythmic medications.', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Freedom from atrial fibrillation on or off antiarrhythmic medications at 3, 6 and 12 months post-first ablation procedure.', 'timeFrame': '12 months'}, {'measure': 'Freedom from atrial fibrillation and other atrial arrhythmias at 3, 6 and 12 months post-first ablation procedure.', 'timeFrame': '12 months'}, {'measure': 'Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, and death.', 'timeFrame': '12 months'}, {'measure': 'Procedure duration at ablation.', 'timeFrame': 'At intervention'}, {'measure': 'Fluoroscopy time at ablation.', 'timeFrame': 'At intervention'}, {'measure': 'Quality of life measurements (SF-36) at baseline, 3, 6 and 12 months post-first procedure.', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['paroxysmal atrial fibrillation', 'persistent atrial fibrillation', 'high burden of atrial fibrillation', 'atrial fibrillation ablation', 'Pulmonary vein isolation', 'AF trigger', 'complex fractionated electrograms', 'CFE', 'CFAE', 'complex fractionated atrial electrograms', 'refractory antiarrhythmic medication', 'PVAI', 'Ensite NavX', 'NavX', 'CoolPath catheter', 'irrigated ablation catheter', 'high burden of paroxysmal or persistent atrial fibrillation', 'candidates for AF ablation', 'symptomatic AF', 'AF is refractory to at least one antiarrhythmic medication'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '20215126', 'type': 'DERIVED', 'citation': 'Verma A, Mantovan R, Macle L, De Martino G, Chen J, Morillo CA, Novak P, Calzolari V, Guerra PG, Nair G, Torrecilla EG, Khaykin Y. Substrate and Trigger Ablation for Reduction of Atrial Fibrillation (STAR AF): a randomized, multicentre, international trial. Eur Heart J. 2010 Jun;31(11):1344-56. doi: 10.1093/eurheartj/ehq041. Epub 2010 Mar 9.'}]}, 'descriptionModule': {'briefSummary': 'Patient Population: Patients with AF that is symptomatic and refractory to at least one antiarrhythmic medication. Patients must have AF that is paroxysmal (\\>4 episodes within 6 months, two episodes \\>6 hours within 1 year) or persistent (sustained episode \\<6 months terminated by cardioversion or drug).\n\nPurpose: To compare a trigger-based technique (pulmonary vein isolation) to a substrate-based technique (high-frequency, fractionated EGMs) to a combined approach for AF ablation', 'detailedDescription': 'Interventions: Patients will be randomized to either wide circumferential pulmonary vein isolation ("trigger") or ablation of high-frequency, fractionated electrograms during AF ("substrate"), or a hybrid approach combining trigger and substrate. Both techniques will be performed with NavX mapping system and a standardized ablation catheter. Endpoint of PVI will be isolation of all four PVs documented by circular catheter. Endpoint for substrate-based ablation will be termination and noninducibility of AF. Up to 2 procedures will be allowed within 6 months. A 2 month blanking period will be allowed after each procedure during which early recurrences will not be counted.\n\nOutcomes:\n\n* Recurrence of atrial fibrillation or other atrial tachycardia at 3, 6, and 12 months post-initial procedure.\n* Recurrence will be defined by symptoms and/or ECG/Holter data showing AF \\> 2 mins\n* Occurrence of adverse events in each group post-procedure.\n* Quality of life assessment at 6 and 12 months post-initial procedure.\n\nFollowup:\n\n* 3, 6, and 12 months post-initial procedure.\n* Clinical data, ECG, Holter, loop recorder at baseline and at each visit.\n* QOL at baseline, 3, 6 and 12 months post-initial procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients age 18 or greater.\n* "high burden" of paroxysmal atrial fibrillation or persistent atrial fibrillation\n* candidates for AF ablation based on AF that is symptomatic and refractory to at least one antiarrhythmic medication.\n* At least one episode of AF must have been documented by ECG or Holter within 12 months of randomization in the trial.\n* continuous anticoagulation with warfarin (INR 2-3) for \\>4 weeks prior to the ablation.\n* Patients must be able and willing to provide written informed consent to participate in the clinical trial.\n\nExclusion Criteria:\n\n* chronic atrial fibrillation.\n* Patients with AF felt to be secondary to an obvious reversible cause.\n* inadequate anticoagulation as defined in the inclusion criteria.\n* left atrial thrombus or spontaneous echo contrast on TEE prior to procedure.\n* contraindications to systemic anticoagulation with heparin or coumadin.\n* previously undergone atrial fibrillation ablation.\n* left atrial size \\> 55 mm.\n* Patients who are or may potentially be pregnant'}, 'identificationModule': {'nctId': 'NCT00367757', 'briefTitle': 'STAR-AF:Substrate Versus Trigger Ablation for Reduction of Atrial Fibrillation Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Open, Prospective, Randomized Trial Comparing Trigger vs Substrate vs Hybrid Approaches for AF Ablation', 'orgStudyIdInfo': {'id': 'AF06002AF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'PVI group', 'description': 'Trigger-based ablation guided by pulmonary vein antrum isolation', 'interventionNames': ['Procedure: Ablate AF triggers via PVI']}, {'type': 'OTHER', 'label': 'CFAE group', 'description': 'Substrate-based ablation using an approach targeting CFAEs', 'interventionNames': ['Procedure: Substrate via CFAEs']}, {'type': 'OTHER', 'label': 'Combined group', 'description': 'Combined trigger and substrate based approach', 'interventionNames': ['Procedure: Combined approach for AF ablation']}], 'interventions': [{'name': 'Ablate AF triggers via PVI', 'type': 'PROCEDURE', 'description': 'Trigger-based ablation guided by pulmonary vein antrum isolation', 'armGroupLabels': ['PVI group']}, {'name': 'Substrate via CFAEs', 'type': 'PROCEDURE', 'description': 'Substrate-based ablation using an approach targeting CFAEs', 'armGroupLabels': ['CFAE group']}, {'name': 'Combined approach for AF ablation', 'type': 'PROCEDURE', 'description': 'Combined trigger and substrate based approach', 'armGroupLabels': ['Combined group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L3Y 2P9', 'city': 'Newmarket', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Southlake Regional Health Centre', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'zip': 'H1T 1C8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Heaert Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'L8L 2X2', 'city': 'Hamilton', 'country': 'Canada', 'facility': 'McMaster University', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'V8R 4R2', 'city': 'Victoria', 'country': 'Canada', 'facility': 'Victoria Cardiac Arrhythmia Trials Inc - Royal Jubilee', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': '70124', 'city': 'Bari', 'state': 'Apulia', 'country': 'Italy', 'facility': 'Clinica Santa Maria', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '31100', 'city': 'Treviso', 'country': 'Italy', 'facility': "Ospedale Regionale Ca'Foncello", 'geoPoint': {'lat': 45.66673, 'lon': 12.2416}}, {'zip': '5021', 'city': 'Bergen', 'state': 'Haukeland', 'country': 'Norway', 'facility': 'Haukeland Universitetssykehus', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'zip': '28007', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital General Universitario Gregorio Marañón', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Atul Verma, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southlake Regional health Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}