Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-01-04 @ 7:57 AM
Study NCT ID:
NCT02274857
Status:
COMPLETED
Last Update Posted:
2020-02-07
First Post:
2014-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kristin.ruffner@abbott.com', 'phone': '651-756-6717', 'title': 'Clinical Program Director', 'organization': 'Abbott'}, 'certainAgreement': {'otherDetails': 'All manuscripts should be submitted to the sponsor for review and comment prior to submission to the publisher.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Standard PVI Ablation', 'description': 'Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent AF.\n\nStandard PVI Ablation: Standard PVI procedure without FIRMap.', 'otherNumAtRisk': 179, 'deathsNumAtRisk': 179, 'otherNumAffected': 0, 'seriousNumAtRisk': 179, 'deathsNumAffected': 1, 'seriousNumAffected': 19}, {'id': 'EG001', 'title': 'FIRM-guided Procedure and PVI', 'description': 'FIRM-guided procedure followed by standard catheter ablation including PVI.\n\nFIRM-Guided Procedure and PVI: FIRM-guided procedure followed by conventional ablation including PVI.', 'otherNumAtRisk': 171, 'deathsNumAtRisk': 171, 'otherNumAffected': 0, 'seriousNumAtRisk': 171, 'deathsNumAffected': 2, 'seriousNumAffected': 28}], 'seriousEvents': [{'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arteriovenous fistula operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroparesis postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericarditis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericardial disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericardial hemmorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peritoneal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vessel puncture site hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Freedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard PVI Ablation', 'description': 'Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent AF.\n\nStandard PVI Ablation: Standard PVI procedure without FIRMap.'}, {'id': 'OG001', 'title': 'FIRM-guided Procedure and PVI', 'description': 'FIRM-guided procedure followed by standard catheter ablation including PVI.\n\nFIRM-Guided Procedure and PVI: FIRM-guided procedure followed by conventional ablation including PVI.'}], 'classes': [{'categories': [{'measurements': [{'value': '92.7', 'groupId': 'OG000'}, {'value': '88.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2179', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7-10 days of the Procedure', 'unitOfMeasure': '% of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) group, defined as subject randomized to a treatment group who had a mapping and/or ablation catheter inserted'}, {'type': 'PRIMARY', 'title': 'Single-procedure Freedom From AF/AT Recurrence at 3 Month Post Index Procedure.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard PVI Ablation', 'description': 'Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent AF.\n\nStandard PVI Ablation: Standard PVI procedure without FIRMap.'}, {'id': 'OG001', 'title': 'FIRM-guided Procedure and PVI', 'description': 'FIRM-guided procedure followed by standard catheter ablation including PVI.\n\nFIRM-Guided Procedure and PVI: FIRM-guided procedure followed by conventional ablation including PVI.'}], 'classes': [{'categories': [{'measurements': [{'value': '76.9', 'groupId': 'OG000'}, {'value': '71.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2782', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '3-month follow up', 'unitOfMeasure': '% of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT: each subject randomized to a treatment group who had a mapping and/or ablation catheter inserted Per Protocol: those subjects in the ITT group who completed all follow-up visits and had no major protocol deviations'}, {'type': 'PRIMARY', 'title': 'Single-procedure Freedom From AF/AT Recurrence at 3 to 12 Months Post Index Procedure.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard PVI Ablation', 'description': 'Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent AF.\n\nStandard PVI Ablation: Standard PVI procedure without FIRMap.'}, {'id': 'OG001', 'title': 'FIRM-guided Procedure and PVI', 'description': 'FIRM-guided procedure followed by standard catheter ablation including PVI.\n\nFIRM-Guided Procedure and PVI: FIRM-guided procedure followed by conventional ablation including PVI.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.5', 'groupId': 'OG000'}, {'value': '69.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7266', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '3-12 months post study treatment', 'unitOfMeasure': '% of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT group, defined as each subject randomized to a treatment group who had a mapping and/or ablation catheter inserted'}, {'type': 'PRIMARY', 'title': 'Freedom From Procedure-related SAEs (Including Those Related to Any Repeat Procedures) Within 12-months of the Initial Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard PVI Ablation', 'description': 'Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent AF.\n\nStandard PVI Ablation: Standard PVI procedure without FIRMap.'}, {'id': 'OG001', 'title': 'FIRM-guided Procedure and PVI', 'description': 'FIRM-guided procedure followed by standard catheter ablation including PVI.\n\nFIRM-Guided Procedure and PVI: FIRM-guided procedure followed by conventional ablation including PVI.'}], 'classes': [{'categories': [{'measurements': [{'value': '146', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3522', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 to 12 months post study treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT group, defined as each subject randomized to a treatment group who had a mapping and/or ablation catheter inserted'}, {'type': 'SECONDARY', 'title': 'Evaluate the Acute Effectiveness of FIRM-guided Procedures in Eliminating the Source of Arrhythmia as Shown by: No Evidence of the Source in FIRMap Post-op, OR Reduction of Electrogram Amplitude to < 0.2 Millivolts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FIRM-guided Procedure and PVI', 'description': 'FIRM-guided procedure followed by standard catheter ablation including PVI.\n\nFIRM-Guided Procedure and PVI: FIRM-guided procedure followed by conventional ablation including PVI.'}], 'classes': [{'categories': [{'measurements': [{'value': '86.1', 'groupId': 'OG000', 'lowerLimit': '79.7', 'upperLimit': '91.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately post procedure', 'unitOfMeasure': '% of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard PVI Ablation', 'description': 'Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent atrial fibrillation (AF).\n\nStandard PVI Ablation: Standard PVI procedure without Focal Impulse and Rotor Modulation Mapping Catheter (FIRMap).'}, {'id': 'FG001', 'title': 'FIRM-guided Procedure and PVI', 'description': 'Focal Impulse and Rotor Modulation (FIRM)-guided procedure followed by standard catheter ablation including PVI.\n\nFIRM-Guided Procedure and PVI: FIRM-guided procedure followed by conventional ablation including PVI.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '179'}, {'groupId': 'FG001', 'numSubjects': '171'}]}, {'type': 'Completed Per Protocol', 'comment': 'Per protocol are subjects in ITT group who completed all follow-ups with no major deviations.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '114'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '159'}, {'groupId': 'FG001', 'numSubjects': '165'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Trial screen failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'BG000'}, {'value': '171', 'groupId': 'BG001'}, {'value': '350', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard PVI Ablation', 'description': 'Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent AF.\n\nStandard PVI Ablation: Standard PVI procedure without FIRMap.'}, {'id': 'BG001', 'title': 'FIRM-guided Procedure and PVI', 'description': 'FIRM-guided procedure followed by standard catheter ablation including PVI.\n\nFIRM-Guided Procedure and PVI: FIRM-guided procedure followed by conventional ablation including PVI.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.7', 'spread': '8.7', 'groupId': 'BG000'}, {'value': '64.2', 'spread': '8.4', 'groupId': 'BG001'}, {'value': '63.4', 'spread': '8.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '253', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '167', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '327', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '159', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '31.12', 'spread': '5.63', 'groupId': 'BG000'}, {'value': '31.17', 'spread': '5.59', 'groupId': 'BG001'}, {'value': '31.15', 'spread': '5.60', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'NYHA Classification', 'classes': [{'title': 'Class I', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}]}, {'title': 'Class II', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}]}, {'title': 'Class III', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'The New York Heart Association Functional Classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina.\n\nClass I = no limitation of physical activity. Class II = slight limitation Class III = marked limitation Class IV = unable to carry on any physical activity without discomfort.', 'unitOfMeasure': 'category'}, {'title': 'Largest Left Atrial Diameter', 'classes': [{'categories': [{'measurements': [{'value': '45.63', 'spread': '9.63', 'groupId': 'BG000'}, {'value': '48.07', 'spread': '7.65', 'groupId': 'BG001'}, {'value': '46.82', 'spread': '8.80', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'LV Ejection Fraction', 'classes': [{'categories': [{'measurements': [{'value': '54.5', 'spread': '8.9', 'groupId': 'BG000'}, {'value': '53.8', 'spread': '8.0', 'groupId': 'BG001'}, {'value': '54.2', 'spread': '8.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Prior and concomitant antiarrhythmic drugs (AAD)', 'classes': [{'title': 'Class I AAD', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}, {'title': 'Class 2 AAD', 'categories': [{'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '221', 'groupId': 'BG002'}]}]}, {'title': 'Class 3 AAD', 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}]}, {'title': 'Class 4 AAD', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Prior and concomitant use of AADs refers to the types of pharmacological therapies a participant has been on or is on in order to treat their arrhythmia. Participants may be on more than one type of AAD.\n\nClass 1 AAD = Sodium Channel Blockers Class 2 AAD = Beta-Adrenoceptor Antagonist Class 3 AAD = Potassium Channel Blockers Class 4 AAD = Calcium Channel Blockers', 'unitOfMeasure': 'participants'}, {'title': 'Hospitalizations for Cardiac Arrhythmias within 6 months of screening', 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Treated for atrial fibrillation in the 6 months prior to enrollment', 'classes': [{'categories': [{'measurements': [{'value': '85.4', 'groupId': 'BG000'}, {'value': '88.9', 'groupId': 'BG001'}, {'value': '87.1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': '%'}, {'title': 'History of significant past and/or concomitant diseases or past surgeries', 'classes': [{'title': 'Cardiovascular', 'categories': [{'measurements': [{'value': '72.1', 'groupId': 'BG000'}, {'value': '67.8', 'groupId': 'BG001'}, {'value': '70.0', 'groupId': 'BG002'}]}]}, {'title': 'CNS/Neurological', 'categories': [{'measurements': [{'value': '10.6', 'groupId': 'BG000'}, {'value': '11.7', 'groupId': 'BG001'}, {'value': '11.1', 'groupId': 'BG002'}]}]}, {'title': 'Dermatologic', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'BG000'}, {'value': '4.7', 'groupId': 'BG001'}, {'value': '4.9', 'groupId': 'BG002'}]}]}, {'title': 'Drug Allergy', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'BG000'}, {'value': '1.8', 'groupId': 'BG001'}, {'value': '2.6', 'groupId': 'BG002'}]}]}, {'title': 'Endocrine/Metabolic', 'categories': [{'measurements': [{'value': '37.4', 'groupId': 'BG000'}, {'value': '30.4', 'groupId': 'BG001'}, {'value': '34.0', 'groupId': 'BG002'}]}]}, {'title': 'Eyes/Ears/Nose/Throat', 'categories': [{'measurements': [{'value': '11.2', 'groupId': 'BG000'}, {'value': '12.9', 'groupId': 'BG001'}, {'value': '12.0', 'groupId': 'BG002'}]}]}, {'title': 'Gastrointestinal', 'categories': [{'measurements': [{'value': '18.4', 'groupId': 'BG000'}, {'value': '23.4', 'groupId': 'BG001'}, {'value': '20.9', 'groupId': 'BG002'}]}]}, {'title': 'Genitourinary', 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'BG000'}, {'value': '12.9', 'groupId': 'BG001'}, {'value': '10.9', 'groupId': 'BG002'}]}]}, {'title': 'Hematologic', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'BG000'}, {'value': '4.1', 'groupId': 'BG001'}, {'value': '4.6', 'groupId': 'BG002'}]}]}, {'title': 'Hepatic', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'BG000'}, {'value': '2.9', 'groupId': 'BG001'}, {'value': '2.6', 'groupId': 'BG002'}]}]}, {'title': 'Immunological', 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'BG000'}, {'value': '4.7', 'groupId': 'BG001'}, {'value': '4.3', 'groupId': 'BG002'}]}]}, {'title': 'Malignancy', 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'BG000'}, {'value': '5.3', 'groupId': 'BG001'}, {'value': '5.4', 'groupId': 'BG002'}]}]}, {'title': 'Musculoskeletal', 'categories': [{'measurements': [{'value': '26.3', 'groupId': 'BG000'}, {'value': '28.1', 'groupId': 'BG001'}, {'value': '27.1', 'groupId': 'BG002'}]}]}, {'title': 'Psychiatric', 'categories': [{'measurements': [{'value': '7.3', 'groupId': 'BG000'}, {'value': '5.8', 'groupId': 'BG001'}, {'value': '6.6', 'groupId': 'BG002'}]}]}, {'title': 'Renal', 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'BG000'}, {'value': '11.1', 'groupId': 'BG001'}, {'value': '10.0', 'groupId': 'BG002'}]}]}, {'title': 'Respiratory', 'categories': [{'measurements': [{'value': '24.0', 'groupId': 'BG000'}, {'value': '22.8', 'groupId': 'BG001'}, {'value': '23.4', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '21.2', 'groupId': 'BG000'}, {'value': '26.3', 'groupId': 'BG001'}, {'value': '23.7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': '%'}, {'title': 'Subjects that had LV Ejection Fraction Measured', 'classes': [{'categories': [{'measurements': [{'value': '170', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-08-05', 'size': 276605, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-12-19T15:24', 'hasProtocol': False}, {'date': '2014-06-17', 'size': 2508816, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-12-19T15:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 350}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-03', 'studyFirstSubmitDate': '2014-10-22', 'resultsFirstSubmitDate': '2020-01-06', 'studyFirstSubmitQcDate': '2014-10-23', 'lastUpdatePostDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-03', 'studyFirstPostDateStruct': {'date': '2014-10-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure', 'timeFrame': 'Within 7-10 days of the Procedure'}, {'measure': 'Single-procedure Freedom From AF/AT Recurrence at 3 Month Post Index Procedure.', 'timeFrame': '3-month follow up'}, {'measure': 'Single-procedure Freedom From AF/AT Recurrence at 3 to 12 Months Post Index Procedure.', 'timeFrame': '3-12 months post study treatment'}, {'measure': 'Freedom From Procedure-related SAEs (Including Those Related to Any Repeat Procedures) Within 12-months of the Initial Procedure', 'timeFrame': '3 to 12 months post study treatment'}], 'secondaryOutcomes': [{'measure': 'Evaluate the Acute Effectiveness of FIRM-guided Procedures in Eliminating the Source of Arrhythmia as Shown by: No Evidence of the Source in FIRMap Post-op, OR Reduction of Electrogram Amplitude to < 0.2 Millivolts', 'timeFrame': 'Immediately post procedure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Focal Impulse and Rotor Modulation Mapping Catheter (FIRMap)', 'Rotor', 'FIRM-guided procedure', 'REAFFIRM'], 'conditions': ['Persistent Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The study is a prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM procedures followed by conventional ablation including PVI versus a standard PVI procedure for the treatment of persistent atrial fibrillation (AF).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* At least two (2) documented episodes of persistent atrial fibrillation during prior 3 months\n* Refractory, intolerant, or contraindicated to Class I or III anti-arrhythmic medications\n* Left atrial diameter \\< 6.0 cm\n\nKey Exclusion Criteria:\n\n* Previous AF Ablation\n* Presence of structural heart disease\n* New York Heart Association (NYHA) Class IV.\n* Ejection fraction \\< 35%.\n* History of myocardial infarction (MI) within the past three months.'}, 'identificationModule': {'nctId': 'NCT02274857', 'acronym': 'REAFFIRM', 'briefTitle': 'Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures (REAFFIRM)', 'orgStudyIdInfo': {'id': 'REAFFIRM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard PVI Ablation', 'description': 'Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent AF.', 'interventionNames': ['Procedure: Standard PVI Ablation']}, {'type': 'EXPERIMENTAL', 'label': 'FIRM-guided Procedure and PVI', 'description': 'FIRM-guided procedure followed by standard catheter ablation including PVI.', 'interventionNames': ['Procedure: FIRM-Guided Procedure and PVI']}], 'interventions': [{'name': 'Standard PVI Ablation', 'type': 'PROCEDURE', 'otherNames': ['Pulmonary vein isolation', 'Ablation', 'Arrhythmia', 'Persistent atrial fibrillation', 'Mapping'], 'description': 'Standard PVI procedure without FIRMap.', 'armGroupLabels': ['Standard PVI Ablation']}, {'name': 'FIRM-Guided Procedure and PVI', 'type': 'PROCEDURE', 'otherNames': ['Pulmonary vein isolation', 'Ablation', 'Arrhythmia', 'Persistent atrial fibrillation', 'Mapping', 'FIRMap'], 'description': 'FIRM-guided procedure followed by conventional ablation including PVI.', 'armGroupLabels': ['FIRM-guided Procedure and PVI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Heart Rhythm Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92658', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Hoag Memorial Hospital Presbyterian', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loyola University Medical Center', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University - Krannert Institute of Cardiology', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'St. Vincent Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack UMC', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Medical College at Cornell University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'city': 'Wilkes-Barre', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger Wyoming Valley Medical Center', 'geoPoint': {'lat': 41.24591, 'lon': -75.88131}}, {'zip': '32545', 'city': 'Bad Oeynhausen', 'state': 'Minden-Lübbecke', 'country': 'Germany', 'facility': 'Herz- und Diabeteszentrum Bad Oeynhausen', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}, {'zip': '12683', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Unfallkrankenhaus Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '96450', 'city': 'Coburg', 'country': 'Germany', 'facility': 'Klinikum Coburg GmbH', 'geoPoint': {'lat': 50.25937, 'lon': 10.96384}}, {'zip': '01099', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Karlsruhe', 'country': 'Germany', 'facility': 'Städtisches Klinikum Karlsruhe gGmbH', 'geoPoint': {'lat': 49.00937, 'lon': 8.40444}}, {'zip': '04289', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Leipzig Heart Institute GmbH', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '14471', 'city': 'Potsdam', 'country': 'Germany', 'facility': 'Kardiologische Gemeinschaftspraxis am Park Sanssouci', 'geoPoint': {'lat': 52.39886, 'lon': 13.06566}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'overallOfficials': [{'name': 'Johannes Brachmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum Coburg GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}