Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2026-03-12 @ 10:42 AM
Study NCT ID:
NCT01693120
Status:
TERMINATED
Last Update Posted:
2025-02-13
First Post:
2012-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Phased Radio Frequency Ablation System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'robert.hokanson@medtronic.com', 'phone': '763.526.2811', 'title': 'Bob Hokanson, Clinical Research Manager', 'organization': 'Medtronic AF Solutions'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study stopped enrolling prematurely due to slow enrollment. Since the achieved sample size is 57% smaller than the planned sample size of 300 evaluable subjects, the study objectives could not be properly evaluated.'}}, 'adverseEventsModule': {'timeFrame': 'All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit', 'eventGroups': [{'id': 'EG000', 'title': 'Ablation', 'description': 'Phased RF ablation\n\nMedtronic Phased RF Ablation System: Phased RF ablation', 'otherNumAtRisk': 129, 'deathsNumAtRisk': 129, 'otherNumAffected': 38, 'seriousNumAtRisk': 129, 'deathsNumAffected': 0, 'seriousNumAffected': 28}], 'otherEvents': [{'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Incision site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Chronotropic incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Tracheobronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Incision site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Tendon injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vascular pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Procedure and/or Device Related Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ablation', 'description': 'Phased RF ablation\n\nMedtronic Phased RF Ablation System: Phased RF ablation'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.175', 'groupIds': ['OG000'], 'paramType': 'rate', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '1.6', 'ciUpperLimit': '4.9', 'groupDescription': 'The null hypothesis was that the procedure or device related stroke rate within 30-days of a Phased RF ablation procedure was 3.5% or greater. The alternative hypothesis was that this rate was less than 3.5%. A sample size of 300 subjects provided 90% power to test the null hypothesis assuming the true stroke rate was 1.0% with a one-sided type I error rate of 0.05', 'statisticalMethod': 'exact binomial test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'A stroke with with a symptom onset date within 30 days of an ablation procedure where at least one Phased RF ablation catheter was deployed into the left atrium considered related to the procedure and/or the investigational device by the independent clinical events committee', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with a Phased RF ablation procedure who did not have a non-investigational catheter placed in the left atrium'}, {'type': 'SECONDARY', 'title': '6-month Post-procedure Effectiveness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ablation', 'description': 'Phased RF ablation\n\nMedtronic Phased RF Ablation System: Phased RF ablation'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '52.6', 'ciLowerLimit': '43.1', 'ciUpperLimit': '62.1', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The goal of the analysis was to compute a two-sided 95% confidence interval around the 6-month effectiveness rate. There was no pre-specified hypothesis.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'For a participant, the 6-month effectiveness defined as meeting all of the following criteria: (1) acute procedural success, (2) greater than 90% reduction in atrial fibrillation/atrial flutter episodes lasting longer than 10 minutes as measured by 48-hour ambulatory ECG, (3) No amiodarone use for 90 days and no class I or class III antiarrhythmic drugs for at least 60 days prior to 6-month ambulatory ECG, and (4) free from direct current cardioversion for at least 60 days prior to the 6-month ambulatory ECG', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 129 subjects with an index Phased RF ablation procedure, 114 were evaluable for the 6-month efficacy objective. There were 15 subjects that were not included in the 6-month efficacy objective; 13 due to study exit prior to the 6-month visit and 2 due to no 6-month ambulatory ECG'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Acute Procedural Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ablation', 'description': 'Phased RF ablation\n\nMedtronic Phased RF Ablation System: Phased RF ablation'}], 'classes': [{'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '90.7', 'ciLowerLimit': '84.3', 'ciUpperLimit': '95.1', 'groupDescription': 'There was no prespecified hypothesis tested.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'There was no prespecified hypothesis tested.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 minutes', 'description': 'Acute procedural success defined as: (1) Only Phased RF ablation catheters used in the left atrium, (2) all targeted pulmonary veins isolated, (3) all complex fractionated atrial electrograms and high frequency intracardiac electrogram amplitudes were mapped and ablated, and (4) sinus rhythm was restored at the end of the ablation procedure (with or without cardioversion)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who underwent a Phased RF study procedure'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Pulmonary Vein Stenosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ablation', 'description': 'Phased RF ablation\n\nMedtronic Phased RF Ablation System: Phased RF ablation'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '0', 'ciUpperLimit': '6.1', 'groupDescription': 'There was no pre-specified hypothesis to test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'There was no pre-specified hypothesis to test'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'Greater than 70 percent reduction in the luminal diameter in any one or more of the pulmonary veins following a Phased RF ablation procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects selected for participation in the pulmonary vein assessment cohort with baseline and 3-month evaluable magnetic resonance imaging scans of the pulmonary veins'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ablation', 'description': 'Phased RF ablation\n\nMedtronic Phased RF Ablation System: Phased RF ablation'}], 'periods': [{'title': 'Enrollment', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '70 subjects exited the study after consent, but prior to undergoing a study ablation procedure.', 'groupId': 'FG000', 'numSubjects': '199'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '129 of the 199 enrolled subjects underwent a Phased RF study procedure', 'groupId': 'FG000', 'numSubjects': '129'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '46'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Study closed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Phased RF Study Procedure and Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '112 of the 129 subjects with a Phased RF procedure completed the 6-month follow-up visit', 'groupId': 'FG000', 'numSubjects': '112'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'The first subject was enrolled on 05 November 2013 and the first Phased RF procedure occurred on 17 December 2013. Enrollment into the VICTORY AF study was closed on 26 June 2016 prior to reaching the target sample size due to slower than expected enrollment rate.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ablation', 'description': 'Phased RF ablation\n\nMedtronic Phased RF Ablation System: Phased RF ablation'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.6', 'spread': '7.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '103', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '123', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Atrial fibrillation type', 'classes': [{'categories': [{'title': 'persistent atrial fibrillation', 'measurements': [{'value': '108', 'groupId': 'BG000'}]}, {'title': 'long-term persistent atrial fibrillation', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The baseline analysis population is the number of subjects that had an ablation attempt with the Phased RF system.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-11-21', 'size': 5002857, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-02-07T00:18', 'hasProtocol': True}, {'date': '2013-07-18', 'size': 1624100, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-02-07T00:20', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Treatment with Phased RF Ablation System'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 199}}, 'statusModule': {'whyStopped': 'The study was stopped solely based on lower than expected enrollment rate.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2017-02-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2012-09-19', 'resultsFirstSubmitDate': '2018-02-07', 'studyFirstSubmitQcDate': '2012-09-21', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-21', 'studyFirstPostDateStruct': {'date': '2012-09-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Procedure and/or Device Related Stroke', 'timeFrame': '30 days', 'description': 'A stroke with with a symptom onset date within 30 days of an ablation procedure where at least one Phased RF ablation catheter was deployed into the left atrium considered related to the procedure and/or the investigational device by the independent clinical events committee'}], 'secondaryOutcomes': [{'measure': '6-month Post-procedure Effectiveness', 'timeFrame': '6 months', 'description': 'For a participant, the 6-month effectiveness defined as meeting all of the following criteria: (1) acute procedural success, (2) greater than 90% reduction in atrial fibrillation/atrial flutter episodes lasting longer than 10 minutes as measured by 48-hour ambulatory ECG, (3) No amiodarone use for 90 days and no class I or class III antiarrhythmic drugs for at least 60 days prior to 6-month ambulatory ECG, and (4) free from direct current cardioversion for at least 60 days prior to the 6-month ambulatory ECG'}, {'measure': 'Number of Participants With Acute Procedural Success', 'timeFrame': '30 minutes', 'description': 'Acute procedural success defined as: (1) Only Phased RF ablation catheters used in the left atrium, (2) all targeted pulmonary veins isolated, (3) all complex fractionated atrial electrograms and high frequency intracardiac electrogram amplitudes were mapped and ablated, and (4) sinus rhythm was restored at the end of the ablation procedure (with or without cardioversion)'}, {'measure': 'Number of Participants With Pulmonary Vein Stenosis', 'timeFrame': '3 months', 'description': 'Greater than 70 percent reduction in the luminal diameter in any one or more of the pulmonary veins following a Phased RF ablation procedure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ablation', 'atrial fibrillation', 'Radio frequency'], 'conditions': ['Persistent Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'VICTORY AF is an IDE, prospective global, multi-center, single arm, controlled, unblinded, investigational clinical study. The purpose of this clinical study is to evaluate the risk of procedure and/or device related strokes in subjects with persistent or long-standing persistent atrial fibrillation (AF) undergoing ablation with the Phased RF System.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of symptomatic persistent or long-standing persistent atrial fibrillation\n* Failure of at least one anti-arrhythmic drug\n\nExclusion Criteria:\n\n* Structural heart disease\n* Prior ablation in left atrium for AF\n* Known sensitivities (or allergy) to heparin, warfarin, contrast media\n* Contraindicated for MRI\n* Invasive cardiovascular procedure performed or planned within 3 month period of ablation procedure'}, 'identificationModule': {'nctId': 'NCT01693120', 'acronym': 'VICTORY-AF', 'briefTitle': 'Evaluation of the Phased Radio Frequency Ablation System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Ablation Solutions'}, 'officialTitle': 'Evaluation of Multielectrode Phased RF Technology in Persistent Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'VICTORY AF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ablation', 'description': 'Phased RF ablation', 'interventionNames': ['Device: Medtronic Phased RF Ablation System']}], 'interventions': [{'name': 'Medtronic Phased RF Ablation System', 'type': 'DEVICE', 'description': 'Phased RF ablation', 'armGroupLabels': ['Ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Cardiovascular - Banner', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Hoag Hospital', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '80528', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'Medical Center of the Rockies', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': "St. Vincent's Ambulatory Care", 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32308', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Tallahassee Research Institute', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Heart Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30501', 'city': 'Gainesville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Northeast Georgia Heart Center', 'geoPoint': {'lat': 34.29788, 'lon': -83.82407}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '50266', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa Heart Center', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Baptist Health Lexington', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '49525', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Spectrum Health Hospitals', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '49855', 'city': 'Marquette', 'state': 'Michigan', 'country': 'United States', 'facility': 'DLP Marquette Physicians Practice', 'geoPoint': {'lat': 46.54354, 'lon': -87.39542}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '55102', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': "HealthEast St Joseph's Hospital", 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '07753', 'city': 'Neptune City', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Jersey Shore University Medical Center', 'geoPoint': {'lat': 40.20011, 'lon': -74.02792}}, {'zip': '28803', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Asheville Cardiology', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'city': 'Doylestown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Doylestown Cardiology - VIAA', 'geoPoint': {'lat': 40.31011, 'lon': -75.12989}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '17822', 'city': 'Wilkes-Barre', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger Wyoming Valley Medical Center', 'geoPoint': {'lat': 41.24591, 'lon': -75.88131}}, {'zip': '75226', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Research Institute - Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "St. Luke's Episcopal Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Research Institute - Plano', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia Medical Center', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Fairfax Hospital', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Medical Center - Cherry Hill', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'L3Y 2P9', 'city': 'Newmarket', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Southlake Regional Health Centre', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'zip': 'H3G 1A4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University Health Centre', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital du Sacre Coeur de Montreal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Debrecen', 'country': 'Hungary', 'facility': 'Debreceni Egyetem', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'city': 'Eindhoven', 'country': 'Netherlands', 'facility': 'Catharina Ziekenhuis', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'St. Antonius Ziekenhuis', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}, {'city': 'Basildon', 'country': 'United Kingdom', 'facility': 'Basildon and Thurrock University Hospitals', 'geoPoint': {'lat': 51.56844, 'lon': 0.45782}}, {'city': 'Blackpool', 'country': 'United Kingdom', 'facility': 'Blackpool, Fylde and Wyre Hospitals', 'geoPoint': {'lat': 53.81667, 'lon': -3.05}}, {'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Newcastle Upon Tyne Hospitals', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'overallOfficials': [{'name': 'John Hummel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Ablation Solutions', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}