Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2026-01-05 @ 11:46 AM
Study NCT ID:
NCT03237858
Status:
COMPLETED
Last Update Posted:
2024-03-27
First Post:
2017-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multiple Cardiac Sensors for the Management of Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'JOE.HOBBS@BSCI.COM', 'phone': '612-206-4703', 'title': 'Joe Hobbs, Clinical Trial Manager', 'organization': 'Boston Scientific'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Patients that were included in Phase I of MANAGE-HF were required to meet inclusion and exclusion criteria. This included evidence of worsened heart failure prior to enrollment, patients with severe kidney impairment or short life expectancy were excluded. Thus, the results are limited to the population that was studied. Furthermore, the small sample size and lack of a control group severely limits the interpretation of the results.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collected for all enrolled subjects from the time of consent until the last Phase I subject had completed their 12-month visit', 'description': 'Manage-HF Phase II was not started, the study was closed after Phase I', 'eventGroups': [{'id': 'EG000', 'title': 'MANAGE-HF Phase I', 'description': 'MANAGE-HF Phase I was an open label, non-randomized single arm study', 'otherNumAtRisk': 200, 'deathsNumAtRisk': 200, 'otherNumAffected': 104, 'seriousNumAtRisk': 200, 'deathsNumAffected': 19, 'seriousNumAffected': 100}], 'otherEvents': [{'term': 'Pulse Generator', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'RA Lead', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'RV Lead', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiovascular-HF', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 227, 'numAffected': 82}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiovascular-Non-HF', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 83, 'numAffected': 51}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 59, 'numAffected': 30}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Pulse Generator', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'RA Lead', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'RV Lead', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiovascular-HF', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 92, 'numAffected': 50}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiovascular-Non-HF', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 79, 'numAffected': 55}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 130, 'numAffected': 63}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Manage-HF Phase I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MANAGE-HF Phase I', 'description': 'Number of participants contributing to the knowledge of the clinical integration of HeartLogic and the alert management process'}], 'classes': [{'categories': [{'measurements': [{'value': '191', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Data was collected from the time of consent until the last Phase I subject had completed their 12-month visit', 'description': 'Phase-I was a single arm non-randomized study used to evaluate and optimize HeartLogic clinical integration and alert management. Phase-I had no outcome measures.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Manage-HF Phase II was not started, the trial was closed after phase I'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MANAGE-HF Phase I', 'description': 'Two hundred subjects were enrolled in Phase I of MANAGE-HF. One hundred forty-four subjects were followed until the last patient enrolled completed his or her12-month visit.\n\nThirty-seven subjects withdrew and 19 subjects died.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '144'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}]}]}], 'recruitmentDetails': 'Manage-HF Phase I began recruitment in August of 2017 and completed recruitment in May of 2019. Last Patient Last visit for Phase I occurred in July of 2020. MANAGE HF Phase I was determined to be sufficient by FDA on January 31, 2023, and phase II was not started.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'MANAGE-HF Phase I', 'description': 'Two hundred subjects were enrolled in Phase I of MANAGE-HF. One hundred forty-four subjects were followed until the last patient enrolled completed his or her12-month visit.\n\nThirty-seven subjects withdrew and 19 subjects died.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67', 'spread': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '129', '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': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '142', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '171', 'groupId': 'BG000'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Heart Failure Hospitalization', 'classes': [{'categories': [{'measurements': [{'value': '112', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ischemic Heart Disease', 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Dilated Cardiomyopathy', 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Idiopathic Cardiomyopathy', 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Valvular disease', 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Valvular surgery', 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Thoracic surgery', 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous Myocardial Infarction', 'classes': [{'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'CABG', 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'QRS duration (ms)', 'classes': [{'categories': [{'measurements': [{'value': '135', 'spread': '31', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'LVEF (%)', 'classes': [{'categories': [{'measurements': [{'value': '25.6', 'spread': '9.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'RVEF (%)', 'classes': [{'categories': [{'measurements': [{'value': '49.3', 'spread': '12.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Chronic Obstructive Pulmonary Disease', 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Asthma', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pulmonary hypertension', 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pulmonary diseases other', 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Peripheral Vascular Disease', 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Renal dysfunction', 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hypertension', 'classes': [{'categories': [{'measurements': [{'value': '144', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'There were 200 subjects enrolled and 191 completed the baseline visit. Demographics, medical history, physical assessment, heart failure assessment, and blood labs were taken at the baseline visit.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-01', 'size': 1051538, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-06T13:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-29', 'studyFirstSubmitDate': '2017-07-20', 'resultsFirstSubmitDate': '2023-11-21', 'studyFirstSubmitQcDate': '2017-07-31', 'lastUpdatePostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-29', 'studyFirstPostDateStruct': {'date': '2017-08-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Manage-HF Phase I', 'timeFrame': 'Data was collected from the time of consent until the last Phase I subject had completed their 12-month visit', 'description': 'Phase-I was a single arm non-randomized study used to evaluate and optimize HeartLogic clinical integration and alert management. Phase-I had no outcome measures.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['heart failure', 'diagnostics', 'heart sounds', 'CRT-D', 'ICD', 'remote monitoring'], 'conditions': ['Heart Failure, Congestive']}, 'referencesModule': {'references': [{'pmid': '35460884', 'type': 'DERIVED', 'citation': 'Hernandez AF, Albert NM, Allen LA, Ahmed R, Averina V, Boehmer JP, Cowie MR, Chien CV, Galvao M, Klein L, Kwan B, Lam CSP, Ruble SB, Stolen CM, Stein K; MANAGE-HF Study. Multiple cArdiac seNsors for mAnaGEment of Heart Failure (MANAGE-HF) - Phase I Evaluation of the Integration and Safety of the HeartLogic Multisensor Algorithm in Patients With Heart Failure. J Card Fail. 2022 Aug;28(8):1245-1254. doi: 10.1016/j.cardfail.2022.03.349. Epub 2022 Apr 21.'}, {'pmid': '35129007', 'type': 'DERIVED', 'citation': 'Heggermont WA, Van Bockstal K. HeartlogicTM: ready for prime time? Expert Rev Med Devices. 2022 Feb;19(2):107-111. doi: 10.1080/17434440.2022.2038133. Epub 2022 Feb 12. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/35460884/', 'label': 'Multiple cArdiac seNsors for mAnaGEment of Heart Failure (MANAGE-HF) - Phase I Evaluation of the Integration and Safety of the HeartLogic Multisensor Algorithm in Patients With Heart Failure'}]}, 'descriptionModule': {'briefSummary': 'The MANAGE-HF study is a multi-center, global, prospective, open label, multi-phase trial intended to evaluate the clinical efficacy of the HeartLogic heart failure diagnostic feature.', 'detailedDescription': "Phase I of the MANAGE-HF trial is not randomized, and is intended to evaluate the clinical integration of HeartLogic for managing patients with heart failure. There are no endpoints.\n\nPhase II of the MANAGE-HF trial will assess the clinical effectiveness of remote monitoring of heart failure patients with implanted CRT-D or ICD cardiac devices that contain the diagnostic feature HeartLogic. This feature uses S1 and S3 heart sounds, night time heart rate, thoracic impedance, and respiration to alert clinicians when a patient's heart failure is worsening. The MANAGE-HF study will compare remote monitoring using HeartLogic alerts to drive heart failure care against patients with remote monitoring but without HeartLogic alerts."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject is age 18 or above, or of legal age to give informed consent\n2. Implanted with an cardiac resynchronization therapy defibrillator (CRT-D) or implantable cardioverter-defibrillator (ICD) device that has HeartLogic\n3. Current symptomatic heart failure or New York Heart Association Class II or III at the time of enrollment\n4. Remotely monitored by LATITUDE 5.0 (or future versions)\n5. Willing and capable of participating in all study visits and complying with medication/treatment requirements associated with this clinical study at an approved clinical study center.\n6. Meet at least one of the three following conditions:\n\n * At least one documented hospitalization with a primary diagnosis of worsening for heart failure during the 12 months prior to enrollment; or\n * Unscheduled outpatient visit with IV diuretic therapy for acute worsening of HF during 90 days prior to enrollment; or\n * N-terminal-pro brain natriuretic peptide (NT-proBNP) greater than 600 pg/mL or brain natriuretic peptide (BNP) greater than 150 pg/mL at any time during 90 days prior to enrollment\n\nExclusion Criteria:\n\n1. The subject is unable to sign or refuses to sign the patient informed consent\n2. Symptomatic heart failure at rest or New York Heart Association Class IV at the time of enrollment\n3. The subject is implanted with unipolar right atrial or right ventricular leads\n4. Subject has received or is scheduled to receive a heart transplant or ventricular assist device within the next 6 months\n5. Subject is pregnant or planning to become pregnant during the study\n6. Subject is enrolled in any other concurrent study (without prior written approval from Boston Scientific, excluding registries)\n7. Glomerular filtration rate \\<25 mL/min who are non-responsive to diuretic therapy or are on chronic renal dialysis\n8. Regularly scheduled intravenous heart failure therapy (for example inotropes or diuretics)\n9. A life expectancy of less than 12 months per clinician discretion\n10. APPLICABLE TO PHASE II ONLY: Subject enrolled in Phase I of MANAGE-HF\n11. APPLICABLE TO PHASE II ONLY: Subject has been managed with HeartLogic Alerts ON at anytime within the past 6 months.'}, 'identificationModule': {'nctId': 'NCT03237858', 'acronym': 'MANAGE-HF', 'briefTitle': 'Multiple Cardiac Sensors for the Management of Heart Failure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Multiple Cardiac Sensors for the Management of Heart Failure', 'orgStudyIdInfo': {'id': '92125179'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'HeartLogic ON', 'description': 'ICD and CRT-D devices with HeartLogic alerts turned ON', 'interventionNames': ['Device: HeartLogic ON']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'HeartLogic OFF', 'description': 'ICD and CRT-D devices with HeartLogic alerts turned OFF', 'interventionNames': ['Device: HeartLogic OFF']}], 'interventions': [{'name': 'HeartLogic ON', 'type': 'DEVICE', 'description': 'Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned OFF', 'armGroupLabels': ['HeartLogic ON']}, {'name': 'HeartLogic OFF', 'type': 'DEVICE', 'description': 'Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned ON', 'armGroupLabels': ['HeartLogic OFF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Heart Center Research, LLC', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Cardiology Associates of Northeast Arkansas', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California Hospital', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Cardiovascular Consultants', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Memorial Hospital', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46805', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Parkview Hospital, Inc.', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '46250', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Community Health Network', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '71105', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Advanced Cardiovascular Specialists', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '56320', 'city': 'Cold Spring', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Centra Care Heart and Vascular Center', 'geoPoint': {'lat': 45.4558, 'lon': -94.42888}}, {'zip': '55102', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'United Heart and Vascular', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '03102', 'city': 'Manchester', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Catholic Medical Center', 'geoPoint': {'lat': 42.99564, 'lon': -71.45479}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Strong Memorial Hospital of the University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Rex Hospital', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Lindner Center for Research and Education at Christ Hosp', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Bethesda North Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97477', 'city': 'Springfield', 'state': 'Oregon', 'country': 'United States', 'facility': 'PeaceHealth Sacred Heart Medical Center', 'geoPoint': {'lat': 44.04624, 'lon': -123.02203}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Milton S Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19067', 'city': 'Yardley', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Cardiology Consultants of Philadelphia', 'geoPoint': {'lat': 40.24566, 'lon': -74.846}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '38138', 'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Stern Cardiovascular', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'zip': '77702', 'city': 'Beaumont', 'state': 'Texas', 'country': 'United States', 'facility': 'Southeast Texas Clinical Research Center', 'geoPoint': {'lat': 30.08605, 'lon': -94.10185}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Sentara Norfolk General Hospital', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '44277', 'city': 'Nantes', 'country': 'France', 'facility': "L'Hôpital privé du Confluent", 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'CHU Pontchaillou', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '97080', 'city': 'Würzburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Würzburg AöR', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}], 'overallOfficials': [{'name': 'Adrian Hernandez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}