Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:18 PM
Study NCT ID:
NCT03518658
Status:
COMPLETED
Last Update Posted:
2021-05-06
First Post:
2018-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
BlueSync Field Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001919', 'term': 'Bradycardia'}, {'id': 'D010358', 'term': 'Patient Participation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}, {'id': 'D055991', 'term': 'Health Records, Personal'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D008499', 'term': 'Medical Records'}, {'id': 'D011996', 'term': 'Records'}, {'id': 'D003625', 'term': 'Data Collection'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'keith.holloman@medtronic.com', 'phone': '763-526-1545', 'title': 'Keith Holloman', 'organization': 'CRHF Clinical'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Not Collected', 'description': 'Not Collected', 'eventGroups': [{'id': 'EG000', 'title': 'Evaluation Group', 'description': 'Adverse events were not collected in the evaluation.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group (Historical)', 'description': 'Adverse events are not available from the control group since the data of these patients is extracted from the Medtronic de-identified CareLink™ database.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Chronic CareLink Transmission Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '128607', 'groupId': 'OG001'}, {'value': '979', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Evaluation Group', 'description': 'Patients implanted with a pacemaker or CRT-P device who will be using remote monitoring via the MyCareLink Heart App\n\nEvaluation Group: Patient receiving exposure to the MyCareLink Heart App during device pairing\n\nOf the 257 enrolled patients, one patient was not available in CareLink database, 4 patients left evaluation early which resulted in data loss, 5 patients had no transmissions scheduled between 1 and 12 months, and 2 subjects had scheduled transmissions completed with another monitor than MyCareLink Heart App.'}, {'id': 'OG001', 'title': 'Control Group (Historical)', 'description': 'Patients with low power implantable devices and CareLink Monitor 2490 (Excluding wireless model 2490C)\n\nControl Group: Patients receiving exposure to the CareLink Monitor 2490 (Excluding wireless model 2490C)\n\nThe enrolled patients in the evaluation were compared to a historical control group from the Medtronic de-identified CareLink™ database. The following inclusion criteria were used to select the analysis group from CareLink comparable to the BlueSync™ field evaluation : a) \\> 18 years of age at implant; b) Patient activated (first received CareLink transmission with CareLink 2490 monitor) in CareLink from 1 Jan 2016 to 1 December 2018; c) Patient followed for at least one year after activation with a minimum of one scheduled transmission in this year, d) US patients, e) Patient did not perform transmission with another monitor for at least one year after activation.'}, {'id': 'OG002', 'title': 'Matched Control Group (Historical)', 'description': "Individual matching was performed using a greedy algorithm to create a matched control group comparable to the evaluation group. The matched control subjects were chosen from the historical control group with low power implantable devices and CareLink Monitor 2490 (excluding 2490C monitor).\n\nSubjects were matched exactly based on age (± 2 years), gender, and number of device chambers (single, dual or triple). For the evaluation group patients' age at screening was used while for the historical control cohort, age at implant was available. A range of two years was chosen since age at implant and age at screening should be within two years for the evaluation group with most patients having zero years between screening and implant."}], 'classes': [{'categories': [{'measurements': [{'value': '94.6', 'groupId': 'OG000', 'lowerLimit': '91.8', 'upperLimit': '96.6'}, {'value': '60.0', 'groupId': 'OG001', 'lowerLimit': '59.7', 'upperLimit': '60.2'}, {'value': '56.3', 'groupId': 'OG002', 'lowerLimit': '53.7', 'upperLimit': '58.9'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '34.7', 'ciLowerLimit': '32.4', 'ciUpperLimit': '37.0', 'pValueComment': 'The threshold for statistical significance was 0.025.', 'statisticalMethod': 'Generalized estimating equation model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '38.3', 'ciLowerLimit': '34.8', 'ciUpperLimit': '41.9', 'pValueComment': 'The threshold for statistical significance was 0.025.', 'statisticalMethod': 'Generalized estimating equation model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Scheduled transmissions between 1 and 12 months after enrollment/CareLink activation', 'description': 'To assess CareLink transmission compliance (adherence to scheduled transmission), the primary objective is to compare the percentages of the CareLink quarterly scheduled transmissions that are completed within the prescribed window during the 12-month follow-up after the baseline visit in the CareLink Database between the evaluation patients who use the MyCareLink Heart™ (MCL) app and patients with low power devices and CareLink monitors 2490 (excluding wireless model 2490C). For both patient groups, all scheduled transmissions between 1 and 12 months after enrollment/CareLink activation were included.\n\nThe results reflect the total percentage of completed transmissions pooled across subjects taking into account that there were several transmissions per subject. A correlated data method was required for the analysis. A 95% confidence interval based on generalized estimating equations for binomial distribution was calculated for the percentage of completed scheduled transmissions.', 'unitOfMeasure': 'Percentage of completed transmissions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Acute CareLink Transmission Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Evaluation Group', 'description': 'Patients implanted with a pacemaker or CRT-P device who will be using remote monitoring via the MyCareLink Heart App\n\nEvaluation Group: Patient receiving exposure to the MyCareLink Heart App during device pairing'}], 'classes': [{'categories': [{'measurements': [{'value': '95.1', 'groupId': 'OG000', 'lowerLimit': '92', 'upperLimit': '97'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Scheduled transmissions in the first month after enrollment', 'description': 'To assess acute CareLink transmission compliance (adherence to scheduled transmission), the secondary objective is to characterize the percentage of the CareLink bi-weekly scheduled transmissions that are completed within the prescribed window during the 1-month follow-up after the baseline visit in the CareLink Database via the MCL Heart™ app. All scheduled transmissions within the first month after enrollment were included in the analysis.\n\nThe results reflect the total percentage of completed transmissions pooled across all subjects taking into account that there were several transmissions per subject. A correlated data method was required for the analysis since there were several transmissions per subject. A two-sided 95% confidence interval based on generalized estimating equations (GEE) for binomial distribution was calculated for the percentage of completed scheduled transmissions.', 'unitOfMeasure': 'Percentage of completed transmissions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'In total, 215 patients had at least one scheduled transmission within the first month, and were available for analysis. Of the 257 enrolled patients, one patient was not available in CareLink, four patients left the evaluation early which resulted in data loss within CareLink, 37 patients had no scheduled transmission in the first month.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Evaluation Group', 'description': 'Patients implanted with a pacemaker or CRT-P device who will be using remote monitoring via the MyCareLink Heart App\n\nEvaluation Group: Patient receiving exposure to the MyCareLink Heart App during device pairing'}, {'id': 'FG001', 'title': 'Control Group (Historical)', 'description': 'Patients with low power implantable devices and CareLink Monitor 2490 (Excluding wireless model 2490C)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Number of patients completing device pairing survey', 'groupId': 'FG000', 'numSubjects': '257'}, {'groupId': 'FG001', 'numSubjects': '128607'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Number of patients completing annual survey', 'groupId': 'FG000', 'numSubjects': '206'}, {'groupId': 'FG001', 'numSubjects': '128607'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': "Historical Controls were not considered enrolled in this study. The patients' data was extracted from Medtronic de-identified CareLink™ database."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '128607', 'groupId': 'BG001'}, {'value': '128864', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Evaluation Group', 'description': 'Patients implanted with a pacemaker or CRT-P device who will be using remote monitoring via the MyCareLink Heart App'}, {'id': 'BG001', 'title': 'Control Group (Historical)', 'description': 'Patients with low power implantable devices and CareLink Monitor 2490 (Excluding wireless model 2490C)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '128607', 'groupId': 'BG001'}, {'value': '128864', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '26485', 'groupId': 'BG001'}, {'value': '26594', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '102072', 'groupId': 'BG001'}, {'value': '102220', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '128607', 'groupId': 'BG001'}, {'value': '128864', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '64.7', 'spread': '15.6', 'groupId': 'BG000'}, {'value': '72.2', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '72.2', 'spread': '11.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '128256', 'groupId': 'BG001'}, {'value': '128513', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '61604', 'groupId': 'BG001'}, {'value': '61713', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '66652', 'groupId': 'BG001'}, {'value': '66800', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'For the control group, the gender information was not available for all subjects in the CareLink database. Gender was unknown for 351 subjects in the control group.'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '128607', 'groupId': 'BG001'}, {'value': '128864', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '152', 'groupId': 'BG000'}, {'value': '128607', 'groupId': 'BG001'}, {'value': '128759', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '128607', 'groupId': 'BG001'}, {'value': '128864', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '128607', 'groupId': 'BG001'}, {'value': '128864', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}, {'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '128607', 'groupId': 'BG001'}, {'value': '128864', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education', 'classes': [{'title': 'Less Than High School', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '128607', 'groupId': 'BG001'}, {'value': '128864', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'This information is not available in CareLink database.', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG002'}]}]}, {'title': 'High School', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '128607', 'groupId': 'BG001'}, {'value': '128864', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'This information is not available in CareLink database.', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG002'}]}]}, {'title': 'Bachelor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '128607', 'groupId': 'BG001'}, {'value': '128864', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'This information is not available in CareLink database.', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG002'}]}]}, {'title': 'Master', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '128607', 'groupId': 'BG001'}, {'value': '128864', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'This information is not available in CareLink database.', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG002'}]}]}, {'title': 'PhD/Doctorate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '128607', 'groupId': 'BG001'}, {'value': '128864', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'This information is not available in CareLink database.', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Patients enrolled in the BlueSync Field Evaluation'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-04', 'size': 689545, 'label': 'Study Protocol: Version 1', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-01-29T08:19', 'hasProtocol': True}, {'date': '2017-07-18', 'size': 532936, 'label': 'Study Protocol: Version 2', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-01-29T08:22', 'hasProtocol': True}, {'date': '2017-07-19', 'size': 607478, 'label': 'Study Protocol: Version 3', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-01-29T08:23', 'hasProtocol': True}, {'date': '2019-12-13', 'size': 568033, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-03-05T05:24', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 257}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2019-12-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-13', 'studyFirstSubmitDate': '2018-04-20', 'resultsFirstSubmitDate': '2021-01-29', 'studyFirstSubmitQcDate': '2018-05-07', 'lastUpdatePostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-13', 'studyFirstPostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Chronic CareLink Transmission Success', 'timeFrame': 'Scheduled transmissions between 1 and 12 months after enrollment/CareLink activation', 'description': 'To assess CareLink transmission compliance (adherence to scheduled transmission), the primary objective is to compare the percentages of the CareLink quarterly scheduled transmissions that are completed within the prescribed window during the 12-month follow-up after the baseline visit in the CareLink Database between the evaluation patients who use the MyCareLink Heart™ (MCL) app and patients with low power devices and CareLink monitors 2490 (excluding wireless model 2490C). For both patient groups, all scheduled transmissions between 1 and 12 months after enrollment/CareLink activation were included.\n\nThe results reflect the total percentage of completed transmissions pooled across subjects taking into account that there were several transmissions per subject. A correlated data method was required for the analysis. A 95% confidence interval based on generalized estimating equations for binomial distribution was calculated for the percentage of completed scheduled transmissions.'}], 'secondaryOutcomes': [{'measure': 'Acute CareLink Transmission Success', 'timeFrame': 'Scheduled transmissions in the first month after enrollment', 'description': 'To assess acute CareLink transmission compliance (adherence to scheduled transmission), the secondary objective is to characterize the percentage of the CareLink bi-weekly scheduled transmissions that are completed within the prescribed window during the 1-month follow-up after the baseline visit in the CareLink Database via the MCL Heart™ app. All scheduled transmissions within the first month after enrollment were included in the analysis.\n\nThe results reflect the total percentage of completed transmissions pooled across all subjects taking into account that there were several transmissions per subject. A correlated data method was required for the analysis since there were several transmissions per subject. A two-sided 95% confidence interval based on generalized estimating equations (GEE) for binomial distribution was calculated for the percentage of completed scheduled transmissions.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['remote monitoring', 'transmission compliance', 'patient engagement'], 'conditions': ['Bradycardia']}, 'descriptionModule': {'briefSummary': 'The purpose of this field evaluation is to collect and evaluate information related to CareLink transmission compliance as well as patient perceived benefit of BlueSync™ and the health care provider perception of the value of BlueSync™ and satisfaction with BlueSync™.', 'detailedDescription': 'The primary goal is to learn how many CareLink quarterly scheduled transmissions are completed within a prescribed time period to assess CareLink scheduled transmission compliance. The evaluation will also assess adoption to remote monitoring, patient perceived benefit of BlueSync™ (how patients interact with the smart device application) and health care provider perception of the value of BlueSync™ and satisfaction with BlueSync™ (benefits experienced by clinicians that use BlueSync™).\n\nThis clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CRF 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CRF 11.24 and 11.44).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients at hospitals and clinics specializing in the implant and followup of pacemakers and CRT-P devices using remote monitoring', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient will be/has been implanted with an Azure™ or Percepta™, Serena™, Solara™ CRT-P device compatible with BlueSync™ (both new and replacement devices are allowed)\n* Patient must own a smart device (Smartphone or tablet) that meets system requirements and be willing to use during evaluation period\n* Patient must be able to complete the required 12-month follow-up after enrollment\n* Patients must be of legal age according to local law\n\nExclusion Criteria:\n\n* Patient unwilling to complete required surveys during 12-month evaluation period'}, 'identificationModule': {'nctId': 'NCT03518658', 'briefTitle': 'BlueSync Field Evaluation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Rhythm and Heart Failure'}, 'officialTitle': 'BlueSync Field Evaluation', 'orgStudyIdInfo': {'id': 'BlueSync Field Evaluation'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Evaluation Group', 'description': 'Patients implanted with a pacemaker or CRT-P device who will be using remote monitoring via the MyCareLink Heart App', 'interventionNames': ['Other: Evaluation Group']}, {'label': 'Control Group', 'description': 'Patients with low power implantable devices and CareLink Monitor 2490 (Excluding wireless model 2490C)', 'interventionNames': ['Other: Control Group (Historical)']}], 'interventions': [{'name': 'Evaluation Group', 'type': 'OTHER', 'description': 'Patient receiving exposure to the MyCareLink Heart App during device pairing', 'armGroupLabels': ['Evaluation Group']}, {'name': 'Control Group (Historical)', 'type': 'OTHER', 'description': "Patients receiving exposure to the CareLink Monitor 2490 (Excluding wireless model 2490C). The patients' data will be extracted from Medtronic de-identified CareLink™ database.", 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Universithy', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '06102', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford Hosital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '32114', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Daytona Heart Group', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '32822', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Cardiovascular Institutes of Orland0', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '56303', 'city': 'Saint Cloud', 'state': 'Minnesota', 'country': 'United States', 'facility': 'CentraCare', 'geoPoint': {'lat': 45.5608, 'lon': -94.16249}}, {'zip': '07450', 'city': 'Ridgewood', 'state': 'New Jersey', 'country': 'United States', 'facility': 'The Valley Hospital', 'geoPoint': {'lat': 40.97926, 'lon': -74.11653}}, {'zip': '27401', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Cone Health', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43213', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Mount Carmel', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '37934', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'East Tennessee Consultants', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'CHI Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Istituto clinico Città Studi', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '37024', 'city': 'Negrar', 'country': 'Italy', 'facility': 'Ospedale Sacro Cuore', 'geoPoint': {'lat': 45.52918, 'lon': 10.93899}}, {'city': 'Rome', 'country': 'Italy', 'facility': 'Provincia Religiosa San Pietro Di Roma', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': 'B71 4HJ', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Sandwell and West Birmingham Hospitals', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'M139WC', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester Royal Infirmary', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'SO166YD', 'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'Southampton', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'city': 'Stoke-on-Trent', 'country': 'United Kingdom', 'facility': 'University Hospital of North Midlands NHS Trust', 'geoPoint': {'lat': 53.00415, 'lon': -2.18538}}], 'overallOfficials': [{'name': 'Khaldoun Trajki, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There are not plans to share IPD with other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Rhythm and Heart Failure', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}