Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-29 @ 9:47 AM
Study NCT ID:
NCT00779857
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2008-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
AtriCure Exclusion of the LAA in Patients Undergoing Concomitant Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002546', 'term': 'Ischemic Attack, Transient'}], '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'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002545', 'term': 'Brain Ischemia'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jlucky@atricure.com', 'phone': '1-513-755-4101', 'title': 'Jim Lucky', 'organization': 'AtriCure, Inc.'}, 'certainAgreement': {'otherDetails': 'The Sponsor can review communications prior to public release and can embargo communication regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the tim submitted to the sponsor for review. The sponsor can redact or modify the proposed publication to remove any language the sponsor believes would be detrimental to intellectual property or inaccurately reflect the results of the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.', 'description': 'An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.', 'eventGroups': [{'id': 'EG000', 'title': 'AtriCure LAA Exclusion System', 'description': 'AtriCure LAA Exclusion System\n\nAtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System', 'otherNumAtRisk': 70, 'otherNumAffected': 63, 'seriousNumAtRisk': 70, 'seriousNumAffected': 35}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 32, 'numAffected': 32}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 30, 'numAffected': 28}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrioventricular Block Complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Failure Congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post Procedural Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heparin-Induced Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrioventricular Block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrioventricular Block Complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Failure Congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Low Cardiac Output Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinoatrial Block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ventricular Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ventricular Septal Defect Acquired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'General Physical Health Deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bile Duct Stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bacteriaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Incision Site Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Drug Administration Error', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Drug Toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Operative Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post Procedural Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Toxic Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Traumatic Lung Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ejection Fraction Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Phrenic Nerve Paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mental Status Changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleuritic Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aortic Dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Device Related Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AtriCure LAA Exclusion System', 'description': 'AtriCure LAA Exclusion System\n\nAtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.0001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Discharge/30 days Post Procedure', 'description': 'The primary safety endpoint is the rate of device related serious adverse events within 30 days post-procedure or hospital discharge, whichever is later, compared with the rates for serious adverse events for LAA exclusion reported in the peer review literature. The safety endpoint was determined based on an independent review of all reported adverse events by an independent cardiac surgeon that was not an investigator in the study.', 'unitOfMeasure': 'Number of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis population is all patients enrolled in the trial. All available data, regardless of whether data are derived within specified time windows will be included in the analysis. Patients who do not complete the entire course of treatment will be included.'}, {'type': 'PRIMARY', 'title': 'Percent of Patients With Complete Occlusion of the Left Atrial Appendage.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AtriCure LAA Exclusion System', 'description': 'AtriCure LAA Exclusion System\n\nAtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System'}], 'classes': [{'categories': [{'measurements': [{'value': '95.1', 'groupId': 'OG000', 'lowerLimit': '88', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 Months Post Procedure', 'description': 'The primary efficacy endpoint is defined as the complete exclusion of the LAA defined by lack of fluid communication between the LA and LAA at both intra-operative (TEE) and 3 month (CT) evaluations and intra-operative verification of completeness of LAA exclusion.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis population for the efficacy endpoint is all patients enrolled into the trial who complete the intended treatment and the required post procedure and follow-up efficacy endpoint assessments (completers). All available data, regardless of whether data are derived within specified time windows, will be included in this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AtriCure LAA Exclusion System', 'description': 'AtriCure LAA Exclusion System\n\nAtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '70 patients treated', 'groupId': 'FG000', 'numSubjects': '70'}]}, {'type': '30 Day Post Procedure', 'achievements': [{'comment': '2 missed Visit', 'groupId': 'FG000', 'numSubjects': '68'}]}, {'type': '3 Month Post Procedure', 'achievements': [{'comment': '3 month follow-up, 65 of the subjects were available for evaluation.', 'groupId': 'FG000', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '12 Month Post procedure, 64 subjects available for evaluation', 'groupId': 'FG000', 'numSubjects': '64'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Missed Visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Treatment subjects were recruited from the routine clinical referral base of one or more surgeons at each investigational site.', 'preAssignmentDetails': 'Subjects were screened for enrollment and consented prior to being brought to the OR with the potential that they may not be eligible based on some criteria evaluated in OR (i.e. left atrial size assessed by TEE).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'AtriCure LAA Exclusion System', 'description': 'AtriCure LAA Exclusion System\n\nAtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '62', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.1', 'spread': '8.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '70 patients treated with AtriClip LAA Exclusion System'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-31', 'studyFirstSubmitDate': '2008-10-23', 'resultsFirstSubmitDate': '2013-02-11', 'studyFirstSubmitQcDate': '2008-10-23', 'lastUpdatePostDateStruct': {'date': '2013-06-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-05-31', 'studyFirstPostDateStruct': {'date': '2008-10-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Device Related Serious Adverse Events', 'timeFrame': 'Discharge/30 days Post Procedure', 'description': 'The primary safety endpoint is the rate of device related serious adverse events within 30 days post-procedure or hospital discharge, whichever is later, compared with the rates for serious adverse events for LAA exclusion reported in the peer review literature. The safety endpoint was determined based on an independent review of all reported adverse events by an independent cardiac surgeon that was not an investigator in the study.'}, {'measure': 'Percent of Patients With Complete Occlusion of the Left Atrial Appendage.', 'timeFrame': '3 Months Post Procedure', 'description': 'The primary efficacy endpoint is defined as the complete exclusion of the LAA defined by lack of fluid communication between the LA and LAA at both intra-operative (TEE) and 3 month (CT) evaluations and intra-operative verification of completeness of LAA exclusion.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['left atrial appendage', 'laa', 'atrial fibrillation', 'afib', 'af', 'stroke', 'tia'], 'conditions': ['Left Atrial Appendage Exclusion']}, 'referencesModule': {'references': [{'pmid': '21906756', 'type': 'DERIVED', 'citation': 'Ailawadi G, Gerdisch MW, Harvey RL, Hooker RL, Damiano RJ Jr, Salamon T, Mack MJ. Exclusion of the left atrial appendage with a novel device: early results of a multicenter trial. J Thorac Cardiovasc Surg. 2011 Nov;142(5):1002-9, 1009.e1. doi: 10.1016/j.jtcvs.2011.07.052. Epub 2011 Sep 8.'}]}, 'descriptionModule': {'briefSummary': 'Prospective, non-randomized trial to evaluate the safety and efficacy of the LAA Exclusion Device (Clip) for the exclusion of the LAA via epicardial tissue approximation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject is greater than or equal to 18 years of age.\n2. Subject has any one of the following risk factors and is thought to benefit from LAA occlusion:\n\n * CHADS score \\> 2\n * Age \\> 75 years\n * Hypertension and age \\> 65 years\n * Previous stroke\n * History of atrial fibrillation (any classification)\n3. Subject is scheduled to undergo elective non-endoscopic cardiac surgical procedure(s) including cardiac surgery for one or more of the following: Mitral valve repair or replacement, Aortic valve repair or placement, Tricuspid valve repair or replacement, Coronary artery bypass procedures, concomitant surgical (ablation or cut-and-sew) Maze procedure, patent foramen ovale (PFO), atrial septal defect (ASD) repair with the device deployed while on or prepared for cardio-pulmonary bypass support.\n4. Subject is willing and able to provide written informed consent.\n5. Subject has a life expectancy of at least 1 year.\n6. Subject is willing and able to return for scheduled follow-up visits.\n\nExclusion Criteria:\n\n1. Previous cardiac surgery\n2. Thrombus in the LAA/LA which cannot be evacuated prior to placement of the Clip.\n3. Patients requiring surgery other than CABG and/or cardiac valve and/or surgical maze procedure and/or PFO closure and/or ASD repair.\n4. NYHA Class IV heart failure symptoms\n5. Need for emergent cardiac surgery (i.e. cardiogenic shock)\n6. Creatinine \\>200 µmol/L\n7. LAA is not appropriate for exclusion based on intraoperative evaluations\n8. Current diagnosis of active systemic infection\n9. Renal failure requiring dialysis or hepatic failure\n10. A known drug and/or alcohol addiction\n11. Mental impairment or other conditions which may not allow the subject to understand the nature, significance and scope of the study\n12. Pregnancy or desire to get pregnant within 12-months of the study treatment\n13. Preoperative need for an intra-aortic balloon pump or intravenous inotropes\n14. Patients who have been treated with thoracic radiation\n15. Patients in current chemotherapy\n16. Patients on long term treatment with steroids not including intermittent use of inhaled steroids for respiratory diseases.\n17. Patients with known connective tissue disorders'}, 'identificationModule': {'nctId': 'NCT00779857', 'acronym': 'EXCLUDE', 'briefTitle': 'AtriCure Exclusion of the LAA in Patients Undergoing Concomitant Cardiac Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'AtriCure, Inc.'}, 'officialTitle': 'Exclusion of the Left Atrial Appendage With the AtriClip LAA Exclusion Device in Patients Undergoing Concomitant Cardiac Surgery', 'orgStudyIdInfo': {'id': 'CP2008-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AtriCure LAA Exclusion System', 'description': 'AtriCure LAA Exclusion System', 'interventionNames': ['Device: AtriCure LAA Exclusion System']}], 'interventions': [{'name': 'AtriCure LAA Exclusion System', 'type': 'DEVICE', 'description': 'Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System', 'armGroupLabels': ['AtriCure LAA Exclusion System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31201', 'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'facility': 'Macon Medical Center', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'zip': '45237', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'St. Francis Heart Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '49506', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Spectrum Health', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '43213', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Mount Carmel East Hospital', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Heart Hospital', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Michael Mack, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor Heart Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AtriCure, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}