Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-30 @ 9:01 AM
Study NCT ID:
NCT01074034
Status:
COMPLETED
Last Update Posted:
2017-08-01
First Post:
2010-02-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
REASSURE AV Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}, {'id': 'D001919', 'term': 'Bradycardia'}], 'ancestors': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'elke.sommerijns@bsci.com', 'phone': '+32 479 76 71 56', 'title': 'Elke Sommerijns', 'organization': 'Boston Scientific'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from ICF signature until the last follow-up visit (three month follow up visit).', 'description': 'An adverse event is defined as any undesirable clinical occurrence. This can be a subject health related complaint, change in health status, or product issue. A clinical event will not be reported if it existed at enrollment and continued unchanged thereafter unless the event worsened considerably and required additional medical or pharmacological treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'B301 Device', 'description': 'B301 ASSURE Device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device', 'otherNumAtRisk': 211, 'deathsNumAtRisk': 211, 'otherNumAffected': 17, 'seriousNumAtRisk': 211, 'deathsNumAffected': 4, 'seriousNumAffected': 52}], 'otherEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 24, 'numAffected': 17}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Adverse reaction - General', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislodgment - Elevated threshold - RV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislodgment - Unable to capture - RA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea - Heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Early ERI - Random component failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Endocrine', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Extracardiac stimulation - RV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Genitourinary', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Guidewire removal- femoral vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Head, eyes, ears, nose, throat (HEENT)', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematological', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma - Pocket (<=30 days post-implant)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inappropriate tachy therapy - SVT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Integumentary', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intermittent claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Latching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Migration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Multiple heart failure symptoms', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Multiple symptoms', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Multi-system failure - Heart failure', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral edema - Heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary edema - Heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary embolism', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulseless electrical activity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal insufficiency - Heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seroma - Pocket (<=30 days post-implant)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Inappropriate Shock Free Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AV Therapy Assessment Group', 'description': 'appropriate system performance of the atrial and ventricular tachyarrhythmia therapies in the ASSURE device\n\nAV Therapy Assessment-B301 investigational device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device'}], 'classes': [{'categories': [{'measurements': [{'value': '97.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Three months post-implant', 'description': 'Incidences of ventricular shock therapy up to three months post implant. Rescue shocks are intended for the treatment of cardiac arrhythmias detected in the ventricle at rates greater than 220 bpm, including arrhythmias that originate in the atria if they are conducted at rates greater than 220 bpm as this can be life threatening if persistent. Shocks delivered for other reasons will be considered inappropriate shocks.', 'unitOfMeasure': '% of shock free rates', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Conversion Success Rate up to Three Months Post-implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'B301 Device', 'description': 'B301 ASSURE Device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device'}], 'classes': [{'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Three months post-implant', 'description': 'For a pacemaker patient who experiences a spontaneous high rate ventricular arrhythmia, the ASSURE device may provide rescue shocks, a faster and more effective response than external methods of rescue. Successful conversion of an episode is defined by conversion to either; sinus rhythm, sinus tachycardia or atrial pacing by one minute post therapy delivery.', 'unitOfMeasure': '% of conversion rates', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'B301 Device', 'description': 'B301 ASSURE Device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '211'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '205'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'AV Therapy Assessment Group', 'description': 'AV Therapy Assessment group, Atrial ATP and Atrial Therapy Suite (ATS)\n\nAV Therapy Assessment-B301 investigational device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device\n\nVentricular tachyarrhythmia rescue shock feature\n\nAV Therapy Assessment-B301 investigational device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.7', 'spread': '10.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '87', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '124', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '211', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 211}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-05', 'studyFirstSubmitDate': '2010-02-22', 'resultsFirstSubmitDate': '2017-03-17', 'studyFirstSubmitQcDate': '2010-02-22', 'lastUpdatePostDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-17', 'studyFirstPostDateStruct': {'date': '2010-02-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inappropriate Shock Free Rate', 'timeFrame': 'Three months post-implant', 'description': 'Incidences of ventricular shock therapy up to three months post implant. Rescue shocks are intended for the treatment of cardiac arrhythmias detected in the ventricle at rates greater than 220 bpm, including arrhythmias that originate in the atria if they are conducted at rates greater than 220 bpm as this can be life threatening if persistent. Shocks delivered for other reasons will be considered inappropriate shocks.'}], 'secondaryOutcomes': [{'measure': 'Conversion Success Rate up to Three Months Post-implant', 'timeFrame': 'Three months post-implant', 'description': 'For a pacemaker patient who experiences a spontaneous high rate ventricular arrhythmia, the ASSURE device may provide rescue shocks, a faster and more effective response than external methods of rescue. Successful conversion of an episode is defined by conversion to either; sinus rhythm, sinus tachycardia or atrial pacing by one minute post therapy delivery.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sudden Cardiac Death', 'Bradycardia']}, 'descriptionModule': {'briefSummary': 'Long term follow-up to monitor safety for patients implanted with a B301 ASSURE device.', 'detailedDescription': 'The Guidant ASSURE device is a fully featured pacemaker with additional atrial and ventricular tachyarrhythmia therapy features. The REASSURE AV study is a clinical evaluation to support approval of these features. This clinical study is intended to provide adequate performance data on two atrial tachyarrhythmia management features, namely the ATS and atrial ATP. In addition data will be collected to verify that the ventricular tachyarrhythmia rescue shock feature performs as intended in the clinical setting in combination with other pacemaker functions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient is willing and capable of providing informed consent at an approved clinical investigational center, and able to attend the investigational center as required by the protocol\n* Patient is implanted with an investigational B301 device as part of the REASSURE AV study\n\nExclusion Criteria:\n\n\\* None'}, 'identificationModule': {'nctId': 'NCT01074034', 'acronym': 'REASSURE', 'briefTitle': 'REASSURE AV Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Clinical Research Evaluation of the ASSURE Device Atrial and Ventricular Tachyarrhythmia Therapies Registry', 'orgStudyIdInfo': {'id': 'G040067'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AV Therapy Assessment group', 'description': 'appropriate system performance of the atrial and ventricular tachyarrhythmia therapies in the ASSURE device', 'interventionNames': ['Device: AV Therapy Assessment-B301 investigational device']}], 'interventions': [{'name': 'AV Therapy Assessment-B301 investigational device', 'type': 'DEVICE', 'description': 'Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device', 'armGroupLabels': ['AV Therapy Assessment group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Alaska Heart Institute', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'city': 'Larkspur', 'state': 'California', 'country': 'United States', 'facility': 'Northern California Heart Care', 'geoPoint': {'lat': 37.93409, 'lon': -122.53525}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Regional Hospital', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Heart and Vascular Institute', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'St. Joseph Hospital', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'city': 'Downers Grove', 'state': 'Illinois', 'country': 'United States', 'facility': 'Good Samaritan Hospital', 'geoPoint': {'lat': 41.80892, 'lon': -88.01117}}, {'city': 'Merrionette Park', 'state': 'Illinois', 'country': 'United States', 'facility': 'Heart Care Research Foundation', 'geoPoint': {'lat': 41.6842, 'lon': -87.70033}}, {'city': 'Hobart', 'state': 'Indiana', 'country': 'United States', 'facility': 'St. Mary Medical Center', 'geoPoint': {'lat': 41.53226, 'lon': -87.25504}}, {'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Mercy Hospital Medical Center', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Central Baptist Hospital', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Louisville Cardiology Medical Group', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Medical Center Cardiologist Research', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'city': 'Owensboro', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Owensboro Mercy Health System', 'geoPoint': {'lat': 37.77422, 'lon': -87.11333}}, {'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Foundation Hospital', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lahey Clinic Medical Center', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Baystate Medical Center', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'city': 'Duluth', 'state': 'Minnesota', 'country': 'United States', 'facility': "Saint Mary's Duluth Clinic", 'geoPoint': {'lat': 46.78327, 'lon': -92.10658}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Anthony's Medical Center", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Sunrise Hospital & Medical Center', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'city': 'Browns Mills', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Deborah Heart and Lung Center', 'geoPoint': {'lat': 39.97261, 'lon': -74.58293}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Christ Hospital - Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Hillcrest Medical Center', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'city': 'Abington', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abington Memorial Hospital', 'geoPoint': {'lat': 40.12067, 'lon': -75.11795}}, {'city': 'West Reading', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Reading Hospital and Medical Center', 'geoPoint': {'lat': 40.3337, 'lon': -75.94743}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor University Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Center For Cardiac Arrhythmias', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Fairfax Hospital', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Sentara Norfolk General Hospital', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Chippenham Medical Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}