Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
Study NCT ID:
NCT03604432
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2018-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Prophylactic Maze to Prevent Atrial Fibrillation in Adult Cardiac Surgery
Sponsor:
Organization:
Raw JSON
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Failure'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Contusion'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Anemia'}, {'term': 'Post op Afib', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'post op Afib'}, {'term': 'Elevated Creatine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Elevated Creatine'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Bradycardia'}], 'seriousEvents': [{'term': 'Post op Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Afib'}, {'term': 'Acute Kidney Injury/ Acute Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'AKI'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Resp. 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Infection/ Pneu'}, {'term': 'Covid 19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Covid-19'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Anemia'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Atrial flutter'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 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'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Documented Post-operative Atrial Fibrillation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Elective cardiac surgery only'}, {'id': 'OG001', 'title': 'Treatment Group', 'description': 'Elective cardiac surgery plus prophylactic maze procedure\n\npropylactic maze: Prophylactic limited left sided maze procedure for subjects in the treatment arm'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of index surgical procedure to date of discharge, on average 1 week.', 'description': 'Per the STS registry definition of occurrence of postoperative atrial fibrillation that requires treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Requiring Antiarrhythmic Medications in the Treatment Group Versus Control Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Elective cardiac surgery only'}, {'id': 'OG001', 'title': 'Treatment Group', 'description': 'Elective cardiac surgery plus prophylactic maze procedure\n\npropylactic maze: Prophylactic limited left sided maze procedure for subjects in the treatment arm'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'immediately after procedure/surgery up to discharge from the hospital, average 1 week', 'description': 'the utilization of antiarrhythmic medication required to manage postoperative atrial fibrillation will be recorded', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Adverse Events Related to Use of the Radiofrequency Device or Left Atrial Appendage Amputation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Elective cardiac surgery only'}, {'id': 'OG001', 'title': 'Treatment Group', 'description': 'Elective cardiac surgery plus prophylactic maze procedure\n\npropylactic maze: Prophylactic limited left sided maze procedure for subjects in the treatment arm'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during the procedure/surgery, up to 8 hours', 'description': 'record and describe any patient related morbidity or adverse outcome related to the radiofrequency pulmonary vein isolation or left atrial appendage removal', 'unitOfMeasure': 'percentage of events', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Requiring Anticoagulants Medications in the Treatment Group Versus Control Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Elective cardiac surgery only'}, {'id': 'OG001', 'title': 'Treatment Group', 'description': 'Elective cardiac surgery plus prophylactic maze procedure\n\npropylactic maze: Prophylactic limited left sided maze procedure for subjects in the treatment arm'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'immediately after procedure/surgery up to discharge from the hospital, on average 1 week', 'description': 'the utilization of anticoagulant medications required to manage postoperative atrial fibrillation will be recorded', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Group', 'description': 'Elective cardiac surgery only'}, {'id': 'FG001', 'title': 'Treatment Group', 'description': 'Elective cardiac surgery plus prophylactic maze procedure\n\nprophylactic maze: Prophylactic limited left sided maze procedure for subjects in the treatment arm'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, 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'75', 'groupId': 'BG000', 'lowerLimit': '71', 'upperLimit': '79'}, {'value': '75', 'groupId': 'BG001', 'lowerLimit': '71', 'upperLimit': '79'}, {'value': '75', 'groupId': 'BG002', 'lowerLimit': '71', 'upperLimit': '79'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-17', 'size': 760939, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-06-22T10:39', 'hasProtocol': True}, {'date': '2021-04-07', 'size': 793147, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-06-22T10:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-14', 'studyFirstSubmitDate': '2018-06-19', 'resultsFirstSubmitDate': '2023-09-06', 'studyFirstSubmitQcDate': '2018-07-19', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-10-14', 'studyFirstPostDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Documented Post-operative Atrial Fibrillation', 'timeFrame': 'From date of index surgical procedure to date of discharge, on average 1 week.', 'description': 'Per the STS registry definition of occurrence of postoperative atrial fibrillation that requires treatment.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Requiring Antiarrhythmic Medications in the Treatment Group Versus Control Group', 'timeFrame': 'immediately after procedure/surgery up to discharge from the hospital, average 1 week', 'description': 'the utilization of antiarrhythmic medication required to manage postoperative atrial fibrillation will be recorded'}, {'measure': 'Percentage of Adverse Events Related to Use of the Radiofrequency Device or Left Atrial Appendage Amputation.', 'timeFrame': 'during the procedure/surgery, up to 8 hours', 'description': 'record and describe any patient related morbidity or adverse outcome related to the radiofrequency pulmonary vein isolation or left atrial appendage removal'}, {'measure': 'Number of Participants Requiring Anticoagulants Medications in the Treatment Group Versus Control Group', 'timeFrame': 'immediately after procedure/surgery up to discharge from the hospital, on average 1 week', 'description': 'the utilization of anticoagulant medications required to manage postoperative atrial fibrillation will be recorded'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'This study will look at performing a prophylactic limited left sided maze procedure during concomitant adult cardiac surgery to prevent the common occurrence of postoperative atrial fibrillation.', 'detailedDescription': 'This is a prospective, single site, randomized, small feasibility study using a FDA approved device for a new indication. Subjects undergoing a CABG, AVR, or CABG/AVR will be randomized 1 to 1 to a control or treatment group. The control group will undergo their index cardiac surgery procedure only. The treatment group will undergo their index cardiac procedure along with a limited left sided maze procedure. The maze procedure will be done with the Atricure synergy ablation system. This is an FDA approved device that will be used for this new indication.\n\nThe left sided limited maze procedure will consist of pulmonary vein isolation and removal of the left atrial appendage.\n\nA total of 60 subjects will be enrolled in this study at a single site.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective cardiac surgery\n* AVR\n* CABG\n* AVR/CABG\n\nExclusion Criteria:\n\n* History of AF/Aflutter\n* Less common cardiac surgeries:\n* aortic root replacement\n* aortic dissections\n* myxoma\n* pericardectomies\n* off-pump procedures\n* redo procedures\n* Subjects with existing pacemakers, AICD\n* Vulnerable population\n* Emergent surgery\n* Currently participating in investigational drug or device study.\n* Subjects currently on antiarrhythmic drugs Class I and III including amiodarone.'}, 'identificationModule': {'nctId': 'NCT03604432', 'acronym': 'PREVENT-AF', 'briefTitle': 'Prophylactic Maze to Prevent Atrial Fibrillation in Adult Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Corewell Health West'}, 'officialTitle': 'Prophylactic Limited Left Sided Maze Procedure to Prevent Post-operative Atrial Fibrillation in Adult Cardiac Surgery Patients', 'orgStudyIdInfo': {'id': '2018-157'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Electric cardiac surgery only'}, {'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'Elective cardiac surgery plus prophylactic maze procedure', 'interventionNames': ['Device: propylactic maze']}], 'interventions': [{'name': 'propylactic maze', 'type': 'DEVICE', 'otherNames': ['Atricure synergy ablation system'], 'description': 'Prophylactic limited left sided maze procedure for subjects in the treatment arm', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Spectrum Health Hospitals', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}], 'overallOfficials': [{'name': 'Charles L Willekes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corewell Health West'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corewell Health West', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiothoracic Surgeon', 'investigatorFullName': 'Charles Willekes', 'investigatorAffiliation': 'Corewell Health West'}}}}