Ignite Creation Date:
2025-12-24 @ 12:54 PM
Ignite Modification Date:
2025-12-24 @ 12:54 PM
Study NCT ID:
NCT01585961
Status:
COMPLETED
Last Update Posted:
2015-01-26
First Post:
2012-03-14
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
NAVISTAR® THERMOCOOL® SF Catheter: Observational Study
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017115', 'term': 'Catheter Ablation'}], 'ancestors': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}, {'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eharris8@its.jnj.com', 'phone': '909-839-7376', 'title': 'Ellen Harris, Project Manager, Clinical Operations', 'organization': 'Biosense Webster'}, 'certainAgreement': {'otherDetails': "There is an agreement between the Principal Investigator (PI)/Institution and the Sponsor (or its agents) that restricts the PI's rights to discuss, present, or publish trial results after the trial is completed. Please contact Biosense Webster for additional information.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Procedure through 7 days post-procedure', 'eventGroups': [{'id': 'EG000', 'title': 'Catheter Ablation', 'description': 'These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.\n\nCatheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.', 'otherNumAtRisk': 508, 'otherNumAffected': 79, 'seriousNumAtRisk': 508, 'seriousNumAffected': 63}], 'otherEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Catheter site hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Catheter site hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fluid Overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sick sinus syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Catheter site hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Device difficult to use (foley)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Subdural hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'International normalized ratio decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Electrocardiogram ST segment depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematocrit decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient global amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Femoral artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Intra-abdominal hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Fluoroscopy Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Catheter Ablation', 'description': 'These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.\n\nCatheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.4', 'spread': '21.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 (procedure)', 'description': 'The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total time.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset of Safety Population with non-missing endpoint data.'}, {'type': 'PRIMARY', 'title': 'Total Procedure Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '507', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Catheter Ablation', 'description': 'These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.\n\nCatheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.'}], 'classes': [{'categories': [{'measurements': [{'value': '169.8', 'spread': '82.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 (procedure)', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset of Safety Population with non-missing endpoint data.'}, {'type': 'PRIMARY', 'title': 'Acute Procedural Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '508', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Catheter Ablation', 'description': 'These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.\n\nCatheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.'}], 'classes': [{'categories': [{'measurements': [{'value': '488', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 (procedure)', 'description': 'Confirmation of entrance and/or exit block across all targeted pulmonary veins.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'Mean Number of Radiofrequency (RF) Applications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '489', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Catheter Ablation', 'description': 'These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.\n\nCatheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.0', 'spread': '35.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 (procedure)', 'description': 'RF applications is defined as the number of times RF energy is delivered during the procedure.', 'unitOfMeasure': 'number of applications', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset of Safety Population with non-missing endpoint data.'}, {'type': 'SECONDARY', 'title': 'Total Radiofrequency (RF) Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '505', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Catheter Ablation', 'description': 'These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.\n\nCatheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.9', 'spread': '37.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 (procedure)', 'description': 'Total RF time is defined as the total time that RF energy is delivered during the procedure.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset of Safety Population with non-missing endpoint data.'}, {'type': 'SECONDARY', 'title': 'Fluid Volume Delivered Via Ablation Catheter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Catheter Ablation', 'description': 'These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.\n\nCatheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.'}], 'classes': [{'categories': [{'measurements': [{'value': '974.2', 'spread': '481.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 (procedure)', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset of Safety Population with non-missing endpoint data.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Repeat Ablations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '508', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Catheter Ablation', 'description': 'These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.\n\nCatheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.'}], 'classes': [{'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Post-procedure AF Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '470', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Catheter Ablation', 'description': 'These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.\n\nCatheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.'}], 'classes': [{'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 Month Visit', 'description': 'Symptoms attributed to paroxysmal atrial fibrillation reported at 12 month visit', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset of Safety Population with non-missing endpoint data.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Lost Work Days, Related to AF, at 12 Month Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '477', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Catheter Ablation', 'description': 'These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.\n\nCatheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 Month Visit', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset of Safety Population with non-missing endpoint data.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Inpatient Hospital Visit(s) Related to Atrial Fibrillation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '489', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Catheter Ablation', 'description': 'These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.\n\nCatheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.'}], 'classes': [{'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 Month Visit', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population with Utilization Data'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Outpatient Emergency Visits Related to Atrial Fibrillation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '489', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Catheter Ablation', 'description': 'These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.\n\nCatheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 Month Visit', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population with Utilization Data'}, {'type': 'SECONDARY', 'title': 'Change in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Catheter Ablation', 'description': 'These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.\n\nCatheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.0', 'spread': '23.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening to 12 Month Visit', 'description': 'Change is calculated as 12 month overall AFEQT score minus score at screening. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). Therefore a positive change in score corresponds to improvement in AF symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset of Safety Population with non-missing AFEQT data at 12 months.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Catheter Ablation', 'description': 'These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.\n\nCatheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '511'}]}, {'type': 'Safety', 'achievements': [{'comment': 'Patients ablated with study catheter', 'groupId': 'FG000', 'numSubjects': '508'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '478'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Decision to use non-study catheter', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'Ablation cancelled for slow-heal wound', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Catheter Ablation', 'description': 'These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.\n\nCatheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '265', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '246', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.0', 'spread': '11.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '194', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '317', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '494', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '477', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '511', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Enrolled patients'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 511}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-20', 'studyFirstSubmitDate': '2012-03-14', 'resultsFirstSubmitDate': '2015-01-13', 'studyFirstSubmitQcDate': '2012-04-25', 'lastUpdatePostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-01-20', 'studyFirstPostDateStruct': {'date': '2012-04-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Fluoroscopy Time', 'timeFrame': 'Day 0 (procedure)', 'description': 'The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total time.'}, {'measure': 'Total Procedure Time', 'timeFrame': 'Day 0 (procedure)'}, {'measure': 'Acute Procedural Success', 'timeFrame': 'Day 0 (procedure)', 'description': 'Confirmation of entrance and/or exit block across all targeted pulmonary veins.'}], 'secondaryOutcomes': [{'measure': 'Mean Number of Radiofrequency (RF) Applications', 'timeFrame': 'Day 0 (procedure)', 'description': 'RF applications is defined as the number of times RF energy is delivered during the procedure.'}, {'measure': 'Total Radiofrequency (RF) Time', 'timeFrame': 'Day 0 (procedure)', 'description': 'Total RF time is defined as the total time that RF energy is delivered during the procedure.'}, {'measure': 'Fluid Volume Delivered Via Ablation Catheter', 'timeFrame': 'Day 0 (procedure)'}, {'measure': 'Number of Patients With Repeat Ablations', 'timeFrame': '1 year'}, {'measure': 'Post-procedure AF Symptoms', 'timeFrame': '12 Month Visit', 'description': 'Symptoms attributed to paroxysmal atrial fibrillation reported at 12 month visit'}, {'measure': 'Number of Subjects With Lost Work Days, Related to AF, at 12 Month Visit', 'timeFrame': '12 Month Visit'}, {'measure': 'Number of Patients With Inpatient Hospital Visit(s) Related to Atrial Fibrillation', 'timeFrame': '12 Month Visit'}, {'measure': 'Number of Patients With Outpatient Emergency Visits Related to Atrial Fibrillation', 'timeFrame': '12 Month Visit'}, {'measure': 'Change in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score', 'timeFrame': 'Screening to 12 Month Visit', 'description': 'Change is calculated as 12 month overall AFEQT score minus score at screening. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). Therefore a positive change in score corresponds to improvement in AF symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Symptomatic paroxysmal', 'Atrial fibrillation', 'Observational', 'Acute procedural outcomes', 'Ablation', 'Drug refractory', 'Arrhythmia Recurrent', 'Symptomatic'], 'conditions': ['Atrial Fibrillation', 'Paroxysmal Arrhythmia']}, 'descriptionModule': {'briefSummary': 'This is a prospective, interventional, observational, unblinded, single-arm, multicenter registry of younger and older subjects with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation.', 'detailedDescription': 'This study is to measure the "real-world" acute procedural outcomes (procedural efficiency, acute safety, and effectiveness at one year) associated with use of the NAVISTAR® THERMOCOOL® SF Catheter in a clinical setting in subjects with drug refractory, recurrent symptomatic paroxysmal atrial fibrillation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Older and younger patients with drug refractory, symptomatic paroxysmal atrial fibrillation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation\n* Age 18 years or older\n* Patients must be able and willing to provide written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause\n* Previous ablation for atrial fibrillation\n* Episodes of atrial fibrillation that last longer than 30 days and are terminated via cardioversion\n* Uncontrolled heart failure, or NYHA Class III or IV heart failure\n* Documented intra-atrial thrombus or other abnormality on pre-ablation echocardiogram\n* Contraindication to anticoagulation\n* Stroke, cardiac surgery, unstable angina, myocardial infarction or percutaneous coronary intervention within the past 3 months\n* Awaiting cardiac transplantation\n* Heart disease in which corrective surgery is anticipated within 6 months\n* Enrollment in investigational drug, biologic or device study\n* Subjects unwilling to comply with protocol or follow-up requirements\n* Patients who are pregnant'}, 'identificationModule': {'nctId': 'NCT01585961', 'acronym': 'SFAF', 'briefTitle': 'NAVISTAR® THERMOCOOL® SF Catheter: Observational Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biosense Webster, Inc.'}, 'officialTitle': 'NAVISTAR® THERMOCOOL® SF Catheter: Observational Study in a Younger and Older Drug Refractory, Recurrent, Symptomatic Paroxysmal AF Population', 'orgStudyIdInfo': {'id': 'ThermoCool SF Phase IV'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Catheter Ablation', 'description': 'These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and have provided written informed consent to participate in the study, including consent to undergo catheter ablation with the study device.', 'interventionNames': ['Device: Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter)']}], 'interventions': [{'name': 'Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter)', 'type': 'DEVICE', 'description': 'Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.', 'armGroupLabels': ['Catheter Ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Heart Center Research, LLC', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Alaska Heart Institute, LLC', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Heart Hospital', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Scottsdale Healthcare Research Institute', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Clinical Research', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego Cardiac Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '33462', 'city': 'Atlantis', 'state': 'Florida', 'country': 'United States', 'facility': 'JFK Medical Center', 'geoPoint': {'lat': 26.5909, 'lon': -80.10088}}, {'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital Memorial Medical Center', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '32204', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': "St. Vincent's Ambulatory Care, Inc.", 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33774', 'city': 'Largo', 'state': 'Florida', 'country': 'United States', 'facility': 'Largo Medical Center', 'geoPoint': {'lat': 27.90979, 'lon': -82.78842}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital - Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa General Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "St. Joseph's Hospital of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '31419', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Cardiology Associates of Savannah', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60007', 'city': 'Elk Grove Village', 'state': 'Illinois', 'country': 'United States', 'facility': 'Alexian Brothers Medical Center', 'geoPoint': {'lat': 42.00392, 'lon': -87.97035}}, {'zip': '62701', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Prairie Education and Research Cooperative', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '46804', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Lutheran Medical Group, LLC', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '55242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospital & Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Hospitals', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Central Baptist Hospital', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '40207', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Baptist Hospital', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Cardiovascular Research Foundation of Louisiana', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '20912', 'city': 'Takoma Park', 'state': 'Maryland', 'country': 'United States', 'facility': 'Washington Adventist Hospital', 'geoPoint': {'lat': 38.97789, 'lon': -77.00748}}, {'zip': '55102', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'United Heart and Vascular Clinic', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Luke's Mid American Heart Institute", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '68506', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Bryan LGH Heart Institute', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '68131', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'The Cardiac Center of Creighton University', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '07960', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Morristown Medical Center', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore University Hospital', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Presbyterian Hospital, Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Bethesda North Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43214', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Riverside Methodist Hospital', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43701', 'city': 'Zanesville', 'state': 'Ohio', 'country': 'United States', 'facility': 'Genesis Healthcare Systems', 'geoPoint': {'lat': 39.94035, 'lon': -82.01319}}, {'zip': '18901', 'city': 'Doylestown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Central Bucks Specialists, LTD', 'geoPoint': {'lat': 40.31011, 'lon': -75.12989}}, {'zip': '19141', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Albert Einstein Medical Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Centennial Heart', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37232-8802', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Heart and Vascular Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor All Saints Medical Center', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '76501', 'city': 'Grapevine', 'state': 'Texas', 'country': 'United States', 'facility': 'Plaza Medical Center', 'geoPoint': {'lat': 32.93429, 'lon': -97.07807}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Heart Institute at St. Luke's Episcopal Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Cardiac Study Center', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '54301', 'city': 'Green Bay', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Bellin Memorial Hospital, Inc.', 'geoPoint': {'lat': 44.51916, 'lon': -88.01983}}], 'overallOfficials': [{'name': 'Gery Tomassoni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central Baptist Hospital'}, {'name': 'Scott Pollak, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Florida Hospital - Orlando'}, {'name': 'Andy Tran, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Scottsdale Healthcare Research Institute'}, {'name': 'Saumil Oza, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Vincent's Ambulatory Care, Inc."}, {'name': 'Steven Compton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alaska Heart Institute, LLC'}, {'name': 'Anshul Patel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Joseph's Hospital of Atlanta"}, {'name': 'Robert Fishel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'JFK Medical Center'}, {'name': 'Kenneth Civello, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiovascular Research Foundation of Louisiana'}, {'name': 'Gaurang Gandhi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bethesda North Hospital'}, {'name': 'Alexandru Costea, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cincinnati'}, {'name': 'Sreedhar Billakanty, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riverside Methodist Hospital'}, {'name': 'H. James Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Florida Hospital Memorial Medical Center'}, {'name': 'John Harding, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central Bucks Specialists, Ltd.'}, {'name': 'Mohammed Khan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexian Brothers Medical Center'}, {'name': 'Vijay Jayachandran, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor All Saints Medical Center'}, {'name': 'Sree Karanam, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lutheran Medical Group, LLC'}, {'name': 'M. Craig Delaughter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Plaza Medical Center'}, {'name': 'Mohammad Jazayeri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bellin Memorial Hospital, Inc.'}, {'name': 'Abdi Rasekh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Texas Heart Institute at St. Luke's Episcopal Hospital"}, {'name': 'Scott Allison, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heart Center Research, LLC'}, {'name': 'Alexander Mazur, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa Hospital & Clinics'}, {'name': 'Dhanunjaya Lakkireddy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Hospitals'}, {'name': 'Alan Wimmer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Luke's Hospital Mid American Heart Institute"}, {'name': 'Ali Hamzei, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Scripps Clinical Research'}, {'name': 'Shalin Shah, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Largo Medical Center'}, {'name': 'Michael Kutayli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bryan LGH Heart Institute'}, {'name': 'John Mandrola, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baptist Hospital'}, {'name': 'Stuart Beldner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'North Shore University Hospital'}, {'name': 'Joshua Moss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}, {'name': 'Greg Bashian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centennial Heart'}, {'name': 'Patrick Whalen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt Heart and Vascular Institute'}, {'name': 'Angelo Biviano, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York Presbyterian Hospital, Columbia University Medical Center'}, {'name': 'Hussam Abuissa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cardiac Center of Creighton University'}, {'name': 'Sumeet Mainigi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albert Einstein Medical Center'}, {'name': 'Charles Athill, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Diego Cardiac Center'}, {'name': 'Edward Gerstenfeld, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSF Medical Center'}, {'name': 'Michael Chisner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiology Associates of Savannah'}, {'name': 'Vijendra Swarup, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Arizona Heart Hospital'}, {'name': 'Ziad Issa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prairie Education and Research Cooperative'}, {'name': 'Tariq Salam, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiac Study Center'}, {'name': 'Sung Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington Adventist Hospital'}, {'name': 'M. 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