Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2026-03-03 @ 7:21 PM
Study NCT ID:
NCT02481206
Status:
TERMINATED
Last Update Posted:
2021-01-19
First Post:
2015-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Wearable Cardioverter Defibrillator in Hemodialysis Patients (WED-HED) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}, {'id': 'D017180', 'term': 'Tachycardia, Ventricular'}], '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': 'D013610', 'term': 'Tachycardia'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mosz@zoll.com', 'phone': '724-968-3333', 'title': 'Director of Clinical Affairs', 'organization': 'Zoll'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'An unanticipated adverse device effect is any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.', 'eventGroups': [{'id': 'EG000', 'title': 'Wearable Cardioverter Defibrillator', 'description': 'End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months, in addition to conventional treatment.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 5, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment during hemodialysis initiation will be applied to this arm.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Discomfort', 'notes': 'Discomfort with wearing the device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Frequent false alarms', 'notes': 'study withdrawal due to self-terminating arrhythmia alarms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Experiencing Sudden Cardiac Death (SCD) Mortality as Assessed by Intention-to-Treat Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Wearable Cardioverter Defibrillator', 'description': 'End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months, in addition to conventional treatment.'}, {'id': 'OG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment during hemodialysis initiation will be applied to this arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'This is an intention to treat analysis of SCD, with subjects analyzed by randomization assignment regardless of treatment crossovers or noncompliance. For witnessed deaths, SCD will be defined as an unexpected, non-traumatic, non-self-inflicted fatality in otherwise stable subjects who die within one hour of the onset of the terminal symptoms (dialysis noncompliance or withdrawal subjects excluded). Subjects dying more than one hour after a sudden cardiac arrest from a ventricular arrhythmia will be designated as non-sudden death due to ventricular arrhythmia. For unwitnessed deaths, if the subject is found dead within 24 hours of being well the death will be designated as SCD. If more than 24 hours has passed the death will be designated as indeterminate.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Wearable Cardioverter Defibrillator', 'description': 'End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months, in addition to conventional treatment.'}, {'id': 'OG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment during hemodialysis initiation will be applied to this arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'All cause mortality', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sudden Cardiac Death (SCD) Mortality Assessed by As-treated Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'units': 'patient months', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Wearable Cardioverter Defibrillator Used', 'description': 'Time during which a wearable defibrillator was actually worn, whether in the intention to treat wearable defibrillator arm or the control arm (crossovers). All other time will be analyzed as part of the control group.'}, {'id': 'OG001', 'title': 'Wearable Cardioverter Defibrillator Not Used', 'description': 'Time during which a wearable defibrillator was not worn, whether in the intention to treat wearable defibrillator arm (crossovers) or the control arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.088'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0.012'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'This is an as-treated analysis of SCD. For witnessed deaths, SCD will be defined as an unexpected, non-traumatic, non-self-inflicted fatality in otherwise stable subjects who die within one hour of the onset of the terminal symptoms (dialysis noncompliance or withdrawal subjects excluded). Subjects dying more than one hour after a sudden cardiac arrest from a ventricular arrhythmia will be designated as non-sudden death due to ventricular arrhythmia. For unwitnessed deaths, if the subject is found dead within 24 hours of being well the death will be designated as SCD. If more than 24 hours has passed the death will be designated as indeterminate.', 'unitOfMeasure': 'patient months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'patient months', 'denomUnitsSelected': 'patient months', 'populationDescription': 'To allow for crossovers, the analysis unit is patient months. Note: There were crossover months in the treatment group that were included in the control group for this as-treated analysis. That is, since all WCD users had months during which they did not use a WCD, they are also counted in the WCD not used group.'}, {'type': 'SECONDARY', 'title': 'Clinical Status of Sudden Cardiac Arrest (SCA) Survivors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Wearable Cardioverter Defibrillator', 'description': 'End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months, in addition to conventional treatment.'}, {'id': 'OG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment during hemodialysis initiation will be applied to this arm.'}], 'timeFrame': '48 hours after SCA', 'description': 'This is an intention to treat analysis of the clinical status of participants who experience an SCA and survive at least 48 hours, as determined by the Glasgow Coma Scale (numeric scale is 3 to 14, higher is better).', 'reportingStatus': 'POSTED', 'populationDescription': 'Study participants from both arms who experienced SCA.'}, {'type': 'SECONDARY', 'title': 'Incidence of Potentially Life Threatening Arrhythmias', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}, {'units': 'patient-months', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Wearable Cardioverter Defibrillator', 'description': 'End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months, in addition to conventional treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.098'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'In the Wearable Cardioverter Defibrillator arm, determine the incidence of potentially life-threatening arrhythmias while the device was worn. Life-threatening arrhythmias are defined as ventricular tachycardia over 150 beats per minute and ventricular fibrillation (VTVF).', 'unitOfMeasure': 'VTVF per patient-month', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'patient-months', 'denomUnitsSelected': 'patient-months', 'populationDescription': 'All subjects using a wearable cardioverter defibrillator were included (treatment group assignment and crossovers from control group assignment). Only months with wearable cardioverter defibrillator use were used for calculations.'}, {'type': 'SECONDARY', 'title': 'Risk of Inappropriate Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}, {'units': 'patient months', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Wearable Cardioverter Defibrillator', 'description': 'End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months, in addition to conventional treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.098'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Device reported inappropriate shocks/treatments during patient wear time in experimental device wearing arm', 'unitOfMeasure': 'inappropriate shocks per patient month', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'patient months', 'denomUnitsSelected': 'patient months', 'populationDescription': 'All subjects using a wearable cardioverter defibrillator were included (treatment group assignment and crossovers from control group assignment). Only months with wearable cardioverter defibrillator use were used for calculations.'}, {'type': 'SECONDARY', 'title': 'Compliance With Wearable Cardioverter Defibrillator Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Wearable Cardioverter Defibrillator', 'description': 'End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months, in addition to conventional treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '.23', 'spread': '.33', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'In the group randomized to receive a Wearable Cardioverter Defibrillator, the device recorded time of use will be used to determine compliance measured as a % of time available for use.', 'unitOfMeasure': 'Percentage of time available for use', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All trial participants who were randomized to wear a wearable cardioverter defibrillator.'}, {'type': 'SECONDARY', 'title': 'Kidney Disease Quality of Life 36-item Short Form Survey (KDQOL-36) As Assessed by As-treated Analysis at 2 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Wearable Cardioverter Defibrillator', 'description': 'End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months, in addition to conventional treatment.'}, {'id': 'OG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment during hemodialysis initiation will be applied to this arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.6', 'spread': '10.6', 'groupId': 'OG000'}, {'value': '82.7', 'spread': '9.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 months', 'description': 'A self completed questionnaire, the KDQOL-36 has five scales scored from 0 to 100, with higher numbers considered better (i.e., better health related quality of life). For reporting the total score, the 5 scales were averaged for each subject, creating a 0 to 100 range with higher scores considered better.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects completing the KDQOL-36 at 2 months.'}, {'type': 'SECONDARY', 'title': 'Kidney Disease Quality of Life 36-item Short Form Survey (KDQOL-36) As Assessed by As-treated Analysis at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Wearable Cardioverter Defibrillator', 'description': 'End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months, in addition to conventional treatment.'}, {'id': 'OG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment during hemodialysis initiation will be applied to this arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.9', 'spread': '12.4', 'groupId': 'OG000'}, {'value': '83.4', 'spread': '11.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'A self completed questionnaire, the KDQOL-36 has five scales scored from 0 to 100, with higher numbers considered better (i.e., better health related quality of life). For reporting the total score, the 5 scales were averaged for each subject, creating a 0 to 100 range with higher scores considered better.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects completing the KDQOL-36 at 6 months.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Wearable Cardioverter Defibrillator', 'description': 'End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months, in addition to conventional treatment.'}, {'id': 'FG001', 'title': 'Conventional Treatment', 'description': 'End Stage Renal Disease (ESRD) patients beginning hemodialysis will get conventional treatment only.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment for the study began on 30-Jun-2015 and ended 15-Feb-2017. Subjects beginning or anticipated to begin dialysis were recruited from kidney clinics and dialysis centers.', 'preAssignmentDetails': 'Since the sudden death rate is highest early after initiating hemodialysis, subjects could be enrolled from 1 month before starting dialysis to 2 months after. All subjects had to have a left ventricular ejection fraction over 50%. Subjects were shown a wearable defibrillator and were anticipated to be able to use it prior to enrollment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Wearable Cardioverter Defibrillator', 'description': 'End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months, in addition to conventional treatment.'}, {'id': 'BG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment during hemodialysis initiation will be applied to this arm.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '59.3', 'spread': '8.6', 'groupId': 'BG000'}, {'value': '60.1', 'spread': '9.5', 'groupId': 'BG001'}, {'value': '59.7', 'spread': '9.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data entry error on one subject in 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': 'Hypertension', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of Heart Failure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Missing data on 3 WCD subjects and 1 Control subject'}, {'title': 'Previous Myocardial Infarction', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Missing data on 2 WCD subjects and 3 Control subjects'}, {'title': 'History of Ventricular Arrhythmias', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Missing data on 2 Control subjects'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-04-22', 'size': 8785630, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-07-22T13:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'whyStopped': 'Lack of subject enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-23', 'studyFirstSubmitDate': '2015-06-08', 'resultsFirstSubmitDate': '2019-09-18', 'studyFirstSubmitQcDate': '2015-06-22', 'lastUpdatePostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-23', 'studyFirstPostDateStruct': {'date': '2015-06-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Experiencing Sudden Cardiac Death (SCD) Mortality as Assessed by Intention-to-Treat Analysis', 'timeFrame': '6 months', 'description': 'This is an intention to treat analysis of SCD, with subjects analyzed by randomization assignment regardless of treatment crossovers or noncompliance. For witnessed deaths, SCD will be defined as an unexpected, non-traumatic, non-self-inflicted fatality in otherwise stable subjects who die within one hour of the onset of the terminal symptoms (dialysis noncompliance or withdrawal subjects excluded). Subjects dying more than one hour after a sudden cardiac arrest from a ventricular arrhythmia will be designated as non-sudden death due to ventricular arrhythmia. For unwitnessed deaths, if the subject is found dead within 24 hours of being well the death will be designated as SCD. If more than 24 hours has passed the death will be designated as indeterminate.'}], 'secondaryOutcomes': [{'measure': 'Total Mortality', 'timeFrame': '6 months', 'description': 'All cause mortality'}, {'measure': 'Sudden Cardiac Death (SCD) Mortality Assessed by As-treated Analysis', 'timeFrame': '6 months', 'description': 'This is an as-treated analysis of SCD. For witnessed deaths, SCD will be defined as an unexpected, non-traumatic, non-self-inflicted fatality in otherwise stable subjects who die within one hour of the onset of the terminal symptoms (dialysis noncompliance or withdrawal subjects excluded). Subjects dying more than one hour after a sudden cardiac arrest from a ventricular arrhythmia will be designated as non-sudden death due to ventricular arrhythmia. For unwitnessed deaths, if the subject is found dead within 24 hours of being well the death will be designated as SCD. If more than 24 hours has passed the death will be designated as indeterminate.'}, {'measure': 'Clinical Status of Sudden Cardiac Arrest (SCA) Survivors', 'timeFrame': '48 hours after SCA', 'description': 'This is an intention to treat analysis of the clinical status of participants who experience an SCA and survive at least 48 hours, as determined by the Glasgow Coma Scale (numeric scale is 3 to 14, higher is better).'}, {'measure': 'Incidence of Potentially Life Threatening Arrhythmias', 'timeFrame': '6 months', 'description': 'In the Wearable Cardioverter Defibrillator arm, determine the incidence of potentially life-threatening arrhythmias while the device was worn. Life-threatening arrhythmias are defined as ventricular tachycardia over 150 beats per minute and ventricular fibrillation (VTVF).'}, {'measure': 'Risk of Inappropriate Therapy', 'timeFrame': '6 months', 'description': 'Device reported inappropriate shocks/treatments during patient wear time in experimental device wearing arm'}, {'measure': 'Compliance With Wearable Cardioverter Defibrillator Therapy', 'timeFrame': '6 months', 'description': 'In the group randomized to receive a Wearable Cardioverter Defibrillator, the device recorded time of use will be used to determine compliance measured as a % of time available for use.'}, {'measure': 'Kidney Disease Quality of Life 36-item Short Form Survey (KDQOL-36) As Assessed by As-treated Analysis at 2 Months', 'timeFrame': '2 months', 'description': 'A self completed questionnaire, the KDQOL-36 has five scales scored from 0 to 100, with higher numbers considered better (i.e., better health related quality of life). For reporting the total score, the 5 scales were averaged for each subject, creating a 0 to 100 range with higher scores considered better.'}, {'measure': 'Kidney Disease Quality of Life 36-item Short Form Survey (KDQOL-36) As Assessed by As-treated Analysis at 6 Months', 'timeFrame': '6 months', 'description': 'A self completed questionnaire, the KDQOL-36 has five scales scored from 0 to 100, with higher numbers considered better (i.e., better health related quality of life). For reporting the total score, the 5 scales were averaged for each subject, creating a 0 to 100 range with higher scores considered better.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ventricular Tachycardia'], 'conditions': ['Sudden Cardiac Death', 'Sudden Cardiac Arrest']}, 'descriptionModule': {'briefSummary': 'A multi-center, prospective, randomized controlled clinical trial with 1:1 assignment of treatment and control. This study will evaluate the impact of wearable cardioverter defibrillator use on sudden cardiac death in incident hemodialysis patients. The study will enroll up to 2,600 subjects. A maximum of 200 sites in the USA will be used for enrollment.', 'detailedDescription': 'Objective:\n\nTo study the impact of wearable cardioverter defibrillator (WCD) use on sudden cardiac death in hemodialysis patients.\n\nStudy Population:\n\nParticipants will be patients beginning hemodialysis (\\<2 months from initiation) who are ≥ 50 years old.\n\nIntervention:\n\nA WCD will be used for protection against sudden cardiac death (SCD).\n\nStudy Design:\n\nThe study will be a multi-center, prospective, randomized controlled trial with 1:1 assignment of treatment and control.\n\nStudy Size:\n\nThe study will enroll up to 2,600 subjects. A maximum of 200 sites will be used for enrollment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* End stage renal disease (ESRD) requiring hemodialysis\n* On hemodialysis for ≤ 2 calendar months or scheduled to begin hemodialysis within 1 calendar month\n* ≥50 years of age\n* Documented Ejection Fraction \\> 35% within the previous calendar year\n* \\- If the patient has been hospitalized for a myocardial infarction or heart failure decompensation, the Ejection Fraction measurement must have occurred during the last hospitalization or after discharge\n\nExclusion Criteria:\n\n* Is receiving or will receive hemodialysis due to acute kidney injury and is not expected to receive subsequent chronic hemodialysis therapy\n* Patient has an active ICD\n* Patient has a unipolar pacemaker\n* Patient has physical or mental conditions preventing him/her from interacting with or wearing a Wearable Cardioverter Defibrillator\n* Patient has a chest circumference at the level of the xiphoid of \\< 24 inches\n* Patient has a chest circumference at the level of the xiphoid of \\> 56 inches\n* Patient has an advance directive prohibiting resuscitation\n* Patient has cancer or other terminal disease (excluding ESRD) with expected survival less than 6 months\n* Patient is medically unstable for reasons not specifically related to kidney disease\n* Patient is scheduled for live-donor kidney transplantation within 6 calendar months\n* Patient is unable to consent'}, 'identificationModule': {'nctId': 'NCT02481206', 'acronym': 'WED-HED', 'briefTitle': 'Wearable Cardioverter Defibrillator in Hemodialysis Patients (WED-HED) Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zoll Medical Corporation'}, 'officialTitle': 'Wearable Cardioverter Defibrillator in Hemodialysis Patients (WED-HED) Study', 'orgStudyIdInfo': {'id': '90D0126'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Wearable Cardioverter Defibrillator', 'description': 'End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months', 'interventionNames': ['Device: Wearable Cardioverter Defibrillator']}, {'type': 'NO_INTERVENTION', 'label': 'Conventional Treatment', 'description': 'Conventional Treatment'}], 'interventions': [{'name': 'Wearable Cardioverter Defibrillator', 'type': 'DEVICE', 'otherNames': ['WCD', 'LifeVest'], 'description': 'Wearable Cardioverter Defibrillator', 'armGroupLabels': ['Wearable Cardioverter Defibrillator']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Corona', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.87529, 'lon': -117.56644}}, {'city': 'Downey', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.94001, 'lon': -118.13257}}, {'city': 'Escondido', 'state': 'California', 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{'lat': 42.65837, 'lon': -83.14993}}, {'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Wojciech Zareba, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}, {'name': 'Charles A. Herzog, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chronic Disease Research Group, Hennepin County Medical Center, University of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zoll Medical Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}