Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-02-25 @ 6:33 PM
Study NCT ID:
NCT01661205
Status:
COMPLETED
Last Update Posted:
2017-05-17
First Post:
2012-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dual Epicardial Endocardial Persistent Atrial Fibrillation(AF) Study (Staged DEEP)
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': 'SZink@AtriCure.com', 'phone': '513-755-4562', 'title': 'Vice President, Clinical Operations', 'organization': 'AtriCure, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '24-months', 'eventGroups': [{'id': 'EG000', 'title': 'AtriCure Bipolar System Combined With a Catheter Ablation', 'description': 'Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart\n\nAblation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart', 'otherNumAtRisk': 26, 'otherNumAffected': 16, 'seriousNumAtRisk': 26, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Diaphragmatic paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cardiac tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Device lead damage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Procedural hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Intervertebral disc degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Unresponsive to stimuli', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vocal cord paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Diaphragmatic paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Ankle operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Heart valve operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Pre-specified Safety Endpoints Occurring in the First 30 Days Post-index Procedure or Hospital Discharge, Whichever is Longer.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AtriCure Bipolar System Combined With a Catheter Ablation', 'description': 'Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart\n\nAblation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days post-index procedure or hospital discharge', 'description': 'Pre-specified events include: Death; Myocardial Infarction; Stroke or TIA; Excess bleeding; Pulmonary vein stenosis; atrio-esophagael fistula; phrenic nerve paralysis; Pericardial effusion; Embolisms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of treated subjects. Although 26 subjects were anesthetized only 25 subjects underwent epicardial procedure per protocol. Physician decided not to treat one of the anesthetized subjects. Another case was aborted and converted to open chest cardioversion. Twenty-four patients underwent endocardial catheter procedures.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Absence of Atrial Fibrillation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AtriCure Bipolar System Combined With a Catheter Ablation', 'description': 'Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart\n\nAblation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 month follow-up', 'description': 'Absence of atrial fibrillation (AF) at twelve month follow-up based on continuous 14 day ECG monitoring, while off all Class I and III antiarrhythmic therapy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who are evaluable for primary efficacy endpoint, defined as all subjects in whom the minimally invasive staged epicardial/ endocardial ablation procedure is attempted and in whom the index-EP procedure and required post-procedure and 12 month follow-up efficacy endpoint assessment has been performed.'}, {'type': 'SECONDARY', 'title': 'Number Subjects With Serious Device or Procedure Related Adverse Event Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AtriCure Bipolar System Combined With a Catheter Ablation', 'description': 'Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart\n\nAblation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart'}], 'classes': [{'title': 'Epicardial AF Procedure', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Investigational Device', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 month follow-up', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Acute Procedure Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AtriCure Bipolar System Combined With a Catheter Ablation', 'description': 'Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart\n\nAblation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0', 'description': 'Defined as subject meeting all of the following criteria upon completion of the index-EP procedure\n\n1. Isolation/block of all pulmonary veins (e.g. 4 of 4 veins);\n2. Bi-directional cavotricuspid isthmus block;\n3. Isolation of Box (i.e. no capture outside ablation lines connecting roof and floor lines between right-and-left pulmonary vein isolation lines);\n4. Superior Vena Cava (SVC) isolation, if encircling SVC lesion performed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subject Without Atrial Fibrillation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AtriCure Bipolar System Combined With a Catheter Ablation', 'description': 'Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart\n\nAblation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart'}], 'classes': [{'title': '6-Months Follow-Up', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': '12-Months Follow-Up', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 and 12 month follow-up', 'description': 'AF free with or without the need of antiarrhythmic drugs', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Reinterventions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AtriCure Bipolar System Combined With a Catheter Ablation', 'description': 'Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart\n\nAblation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 month follow-up', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Direct Current (DC) Cardioversion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AtriCure Bipolar System Combined With a Catheter Ablation', 'description': 'Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart\n\nAblation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 month follow-up', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in AF Based on AF Symptoms Checklist Frequency and Severity Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AtriCure Bipolar System Combined With a Catheter Ablation', 'description': 'Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart\n\nAblation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart'}], 'classes': [{'title': 'Checklist Frequency Score', 'categories': [{'measurements': [{'value': '-16.3', 'spread': '8.6', 'groupId': 'OG000'}]}]}, {'title': 'Checklist Severity Score', 'categories': [{'measurements': [{'value': '-12.6', 'spread': '7.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 month follow-up', 'description': 'Change in Atrial Fibrillation Symptom Checklist Frequency and Severity Scores. This is reported as change from Baseline.\n\n1. This scale has 16 items to assess frequency of occurrence on a scale: Never; Rarely; Sometimes; Often; Always. These rating correspond to numerical values of: 1, 2, 3, 4, and 5, respectively. AF Frequency range from 0 to 80 . Higher scores indicating greater symptomatology.\n2. The same items are also used to assess severity on a scale: Mild; Moderate; Severe. Corresponding to 1, 2, and 3, respectively. AF Severity score range from 0 to 48. Higher scores indicating greater symptomatology.\n3. Negative change from baseline compared to 12-months represents an improvement in AF symptomatology .', 'unitOfMeasure': 'percentage of from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AtriCure Bipolar System Combined With a Catheter Ablation', 'description': 'Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart\n\nAblation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'First subject treated on September 11, 2012. A total of 31 subjects consented from 6 sites (4 USA and 2 Europe). One subject was exited from the study prior to intervention and was re-consented. Only 30 unique subjects were enrolled in the study. Twenty-six subjects treated from 5 sites.', 'preAssignmentDetails': 'Five consented subjects were withdrew prior to treatment. Three did not meet the eligibility criteria, 1 subject was withdrawn by the investigator, and 1 subject withdrew consent.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'AtriCure Bipolar System Combined With a Catheter Ablation', 'description': 'Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart\n\nAblation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.7', 'spread': '9.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '21', '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': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '71.0', 'spread': '3.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'inches', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '220.9', 'spread': '35.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Lbs.', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '30.8', 'spread': '3.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Number of Treated Subjects'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-07', 'studyFirstSubmitDate': '2012-07-11', 'resultsFirstSubmitDate': '2017-02-07', 'studyFirstSubmitQcDate': '2012-08-06', 'lastUpdatePostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-07', 'studyFirstPostDateStruct': {'date': '2012-08-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Pre-specified Safety Endpoints Occurring in the First 30 Days Post-index Procedure or Hospital Discharge, Whichever is Longer.', 'timeFrame': '30 days post-index procedure or hospital discharge', 'description': 'Pre-specified events include: Death; Myocardial Infarction; Stroke or TIA; Excess bleeding; Pulmonary vein stenosis; atrio-esophagael fistula; phrenic nerve paralysis; Pericardial effusion; Embolisms.'}, {'measure': 'Number of Subjects With Absence of Atrial Fibrillation', 'timeFrame': '12 month follow-up', 'description': 'Absence of atrial fibrillation (AF) at twelve month follow-up based on continuous 14 day ECG monitoring, while off all Class I and III antiarrhythmic therapy.'}], 'secondaryOutcomes': [{'measure': 'Number Subjects With Serious Device or Procedure Related Adverse Event Rate', 'timeFrame': '12 month follow-up'}, {'measure': 'Number of Subjects With Acute Procedure Success', 'timeFrame': 'Day 0', 'description': 'Defined as subject meeting all of the following criteria upon completion of the index-EP procedure\n\n1. Isolation/block of all pulmonary veins (e.g. 4 of 4 veins);\n2. Bi-directional cavotricuspid isthmus block;\n3. Isolation of Box (i.e. no capture outside ablation lines connecting roof and floor lines between right-and-left pulmonary vein isolation lines);\n4. Superior Vena Cava (SVC) isolation, if encircling SVC lesion performed.'}, {'measure': 'Number of Subject Without Atrial Fibrillation', 'timeFrame': '6 and 12 month follow-up', 'description': 'AF free with or without the need of antiarrhythmic drugs'}, {'measure': 'Number of Subjects With Reinterventions', 'timeFrame': '12 month follow-up'}, {'measure': 'Number of Subjects With Direct Current (DC) Cardioversion', 'timeFrame': '12 month follow-up'}, {'measure': 'Change in AF Based on AF Symptoms Checklist Frequency and Severity Scores', 'timeFrame': '12 month follow-up', 'description': 'Change in Atrial Fibrillation Symptom Checklist Frequency and Severity Scores. This is reported as change from Baseline.\n\n1. This scale has 16 items to assess frequency of occurrence on a scale: Never; Rarely; Sometimes; Often; Always. These rating correspond to numerical values of: 1, 2, 3, 4, and 5, respectively. AF Frequency range from 0 to 80 . Higher scores indicating greater symptomatology.\n2. The same items are also used to assess severity on a scale: Mild; Moderate; Severe. Corresponding to 1, 2, and 3, respectively. AF Severity score range from 0 to 48. Higher scores indicating greater symptomatology.\n3. Negative change from baseline compared to 12-months represents an improvement in AF symptomatology .'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Persistent AF', 'Longstanding Persistent AF', 'Ablation', 'catheter ablation'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and technical feasibility of treating subjects with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation in a minimally invasive thoracoscopic ablation procedure utilizing the AtriCure Bipolar System, with mapping and additional lesion creation/ gap closure (as needed) provided by currently approved catheter technology, when the epicardial and endocardial phases are performed in a staged manner within 1-10 days apart, during the same hospitalization.', 'detailedDescription': 'The purpose of this clinical investigation is to evaluate how safe a less invasive cardiac surgery using the AtriCure Bipolar System in conjunction with a catheter ablation procedure performed approximately 1-10 days after, in treating atrial fibrillation, and how effective is this staged procedure. The AtriCure Bipolar System will be used to perform the less invasive cardiac surgery and a standard electrophysiology catheter, currently available, will be used to perform the catheter ablation procedure. This surgical procedure is considered less invasive because it is done through tiny surgical punctures on the sides of the chest near the ribs instead of one large surgical incision of the breast bone to completely open the chest and access the heart, and it also avoids the need for the heart-lung bypass machine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\> 18 year\n* Patients with symptomatic persistent or longstanding persistent AF refractory to a minimum of one Class I or III antiarrhythmic drug (AAD).\n* Patients with failed catheter ablation attempts are eligible if the patients are symptomatic with persistent or longstanding persistent AF. (catheter ablation procedure must be more than 3 months prior to index procedure)\n* Life expectancy of at least two years\n* Patient will and able to provide informed consent\n* Patient is willing and able to attend the scheduled follow-up visits\n\nExclusion Criteria:\n\n* Prior Cardiothoracic Surgery\n* Patient has NYHA (New York Heart Association) Class IV heart failure\n* Evidence of underlying structural heart disease requiring surgical treatment\n* Surgical procedure within the 30 days prior to the index procedure\n* Ejection fraction \\< 30%\n* Measured left atrial diameter \\> 6.0 cm\n* Renal Failure\n* Stroke within previous 6 months\n* Known carotid artery stenosis greater than 80%\n* Evidence of significant active infection or endocarditis\n* Pregnant woman or women desiring to become pregnant in the next 24 months\n* Presence of thrombus in the left atrium determined by echocardiography\n* History of blood dyscrasia\n* Contraindication to anticoagulation, based on Investigator's opinion\n* Mural thrombus or tumor\n* Moderate to Severe COPD"}, 'identificationModule': {'nctId': 'NCT01661205', 'acronym': 'Staged DEEP', 'briefTitle': 'Dual Epicardial Endocardial Persistent Atrial Fibrillation(AF) Study (Staged DEEP)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AtriCure, Inc.'}, 'officialTitle': 'Feasibility Trial of a Staged Epicardial & Endocardial Approach for Treatment of Patients With Persistent or Long Standing Persistent Atrial Fibrillation With Radiofrequency Ablation', 'orgStudyIdInfo': {'id': 'CP2012-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AtriCure Bipolar System combined with a catheter ablation', 'description': 'Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart', 'interventionNames': ['Device: Ablation procedure staged catheter ablation']}], 'interventions': [{'name': 'Ablation procedure staged catheter ablation', 'type': 'DEVICE', 'description': 'AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart', 'armGroupLabels': ['AtriCure Bipolar System combined with a catheter ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Springs Cardiology/Colorado Cardiac Alliance', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Heart Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Sentara Norfolk Hospital', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academic Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AtriCure, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}