Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT00746356
Status:
COMPLETED
Last Update Posted:
2019-02-19
First Post:
2008-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Automatic Testing Feature in New ICDs and CRT-Ds
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aoza@sjm.com', 'phone': '818 362 6822', 'title': 'Ashish Oza, Clinical Studies Director', 'phoneExt': '3648', 'organization': 'St. Jude Medical'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '9 months', 'eventGroups': [{'id': 'EG000', 'title': 'All Patients', 'description': 'All patients enrolled in the study', 'otherNumAtRisk': 128, 'otherNumAffected': 33, 'seriousNumAtRisk': 128, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'ecchymosis at implant site', 'notes': 'Adverse events are reported as either a complication or observation (1), defined as an adverse event that requires invasive intervention or an adverse event that can be managed without invasive intervention, respectively.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hematoma', 'notes': '7 observations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'LV lead dislodgement', 'notes': '1 complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'pericardial tamponade', 'notes': '1 complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'erroneous elective replacement alert', 'notes': '3 observations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'high defibrillation thresholds', 'notes': '1 observation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'infection', 'notes': '1 complication, 1 observation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'suspected set screw malfunction', 'notes': '1 complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'suspected generator malfunction', 'notes': '1 complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'elevated pacing thresholds - RA lead', 'notes': '1 observation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'elevated pacing thresholds - RV lead', 'notes': '1 complication, 1 observation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'elevated pacing threshold - LV lead', 'notes': '9 observations, 9 pts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'lead dislodgement/migration - RA lead', 'notes': '2 complications - 2 pts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'lead dislodgement/migration - RV lead', 'notes': '1 complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'lead dislodgement/migration - LV lead', 'notes': '4 complications, 3 pts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'lead insulation damage - RV lead', 'notes': '1 complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'phrenic nerve/diaphragmatic stimulation - LV lead', 'notes': '4 observations, 1 complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'RA and RV lead dislodgement/migration', 'notes': '1 observation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Free of System-related Complications at 3-months Post Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Successfully Implanted With Devices', 'description': 'All participants successfully implanted with an ICD or CRT-D'}], 'classes': [{'categories': [{'measurements': [{'value': '93.6', 'groupId': 'OG000', 'lowerLimit': '89.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months post implant', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2010-11'}, {'type': 'PRIMARY', 'title': 'Atrial AutoCapture (ACap) Confirm Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Dual Chamber ICDs or CRTD Devices', 'description': 'Per protocol, the first 19 participants who successfully completed both an automatic and manual capture threshold'}], 'classes': [{'title': 'Atrial AutoCapture Threshold', 'categories': [{'measurements': [{'value': '0.743', 'spread': '0.357', 'groupId': 'OG000'}]}]}, {'title': 'Manual Capture Threshold', 'categories': [{'measurements': [{'value': '0.737', 'spread': '0.195', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0.0066', 'ciLowerLimit': '-0.25', 'pValueComment': 'P-value was adjusted for multiple efficacy endpoints. If all three primary effectiveness endpoints were met a value of 5% was used, if two were met a value of 2.5% was used, and if one was met a value of 1.67% was used.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.3103', 'groupDescription': 'The null hypothesis was rejected at significance level 1.67% if the mean difference between the automatic test and the manual test was \\<0.25 volts.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'If the data is not normally distributed, then the Wilcoxon signed rank test will be used to perform the two one-sided testing.', 'nonInferiorityComment': 'Sample size was calculated for an 80% power to reject the null hypothesis at 1.67% significance level.'}], 'paramType': 'MEAN', 'timeFrame': '3 months post implant', 'description': 'Atrial AutoCapture Confirm is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the atrial pacing voltage until it determines that the device is no longer capturing the atria. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the atrial pulse voltage and determines the atrial threshold by viewing the EKG.', 'unitOfMeasure': 'Volts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, the first 19 participants who successfully completed both an automatic and manual capture threshold test were included in this analysis.', 'anticipatedPostingDate': '2010-11'}, {'type': 'PRIMARY', 'title': 'Ventricular Autocapture Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Single or Dual Chamber ICDs', 'description': 'Per protocol, the first 38 participants with an ICD who successfully completed both an automatic and manual capture threshold in the right ventricle'}], 'classes': [{'title': 'Automatic Capture Threshold', 'categories': [{'measurements': [{'value': '0.809', 'spread': '0.405', 'groupId': 'OG000'}]}]}, {'title': 'Manual Capture Threshold', 'categories': [{'measurements': [{'value': '0.862', 'spread': '0.442', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0625', 'ciLowerLimit': '-0.25', 'pValueComment': 'P-value was adjusted for multiple efficacy endpoints. If all three primary effectiveness endpoints were met a value of 5% was used, if two were met a value of 2.5% was used and if one was met a value of 1.67% was used.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.0948', 'groupDescription': 'The null hypothesis was rejected at significance level 1.67% if the mean difference between the automatic test and the manual test was \\<0.25 volts.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'If the data is not normally distributed, then the Wilcoxon signed rank test will be used to perform the two one-sided testing.', 'nonInferiorityComment': 'Sample size was calculated for an 80% power to reject the null hypothesis at 1.67% significance level.'}], 'paramType': 'MEAN', 'timeFrame': '3 months post implant', 'description': 'Ventricular AutoCapture is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the ventricular pacing voltage until it determines that the device is no longer capturing the ventricles. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the ventricular pulse voltage and determines the ventricular threshold by viewing the EKG.', 'unitOfMeasure': 'Volts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, the first 38 participants with an ICD who successfully completed both an automatic and manual capture threshold test were included in this analysis.', 'anticipatedPostingDate': '2010-11'}, {'type': 'PRIMARY', 'title': 'Right Ventricular (RV) AutoCapture Effectiveness Endpoint - Difference Between the Automatic and Manual Capture Threshold Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With CRT-D Devices', 'description': 'Per protocol, the first 43 CRT-D participants who successfully completed both an automatic and manual capture threshold in the right ventricle'}], 'classes': [{'title': 'Automatic Capture Threshold', 'categories': [{'measurements': [{'value': '0.739', 'spread': '0.279', 'groupId': 'OG000'}]}]}, {'title': 'Manual Capture Threshold', 'categories': [{'measurements': [{'value': '0.794', 'spread': '0.278', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0556', 'ciLowerLimit': '-0.25', 'pValueComment': 'P-value was adjusted for multiple efficacy endpoints. If all three primary effectiveness endpoints were met a value of 5% was used, if two were met, a value of 2.5% were used and if one was met a value of 1.67% was used.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.0824', 'groupDescription': 'The null hypothesis was rejected at significance level 1.67% if the mean difference between the automatic test and the manual test was \\<0.25 volts.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'If the data is not normally distributed, then the Wilcoxon signed rank test will be used to perform the two one-sided testing.', 'nonInferiorityComment': 'Sample size was calculated for an 80% power to reject the null hypothesis at 1.67% significance level.'}], 'paramType': 'MEAN', 'timeFrame': '3 months post implant', 'description': 'Right Ventricular AutoCapture is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the ventricular pacing voltage until it determines that the device is no longer capturing the ventricles. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the ventricular pulse voltage and determines the ventricular threshold by viewing the EKG.', 'unitOfMeasure': 'Volts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, the first 43 CRT-D participants who successfully completed both an automatic and manual capture threshold in the right ventricle were included in this analysis.', 'anticipatedPostingDate': '2010-11'}, {'type': 'PRIMARY', 'title': 'Left Ventricular (LV) AutoCapture Effectiveness Endpoint - Difference Between the Automatic and Manual Capture Threshold Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With CRT-D Devices', 'description': 'Per protocol, the first 43 CRT-D participants who successfully completed both an automatic and manual threshold in the left ventricle.'}], 'classes': [{'title': 'Automatic Capture Threshold', 'categories': [{'measurements': [{'value': '1.458', 'spread': '0.631', 'groupId': 'OG000'}]}]}, {'title': 'Manual Capture Threshold', 'categories': [{'measurements': [{'value': '1.456', 'spread': '0.618', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0.0028', 'ciLowerLimit': '-0.25', 'pValueComment': 'P-value was adjusted for multiple efficacy endpoints. If three primary effectiveness endpoints were met a value of 5% was used, if two were met a value of 2.5% was used and if one was met a value of 1.67% was used.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.2852', 'groupDescription': 'The null hypothesis was rejected at significance level 1.67% if the mean difference between the automatic test and the manual test was \\<0.25 volts.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'If the data is not normally distributed, then the Wilcoxon signed rank test will be used to perform the two one-sided testing.', 'nonInferiorityComment': 'Sample size was calculated for an 80% power to reject the null hypothesis at 1.67% significance level.'}], 'paramType': 'MEAN', 'timeFrame': '3 months post implant', 'description': 'Left Ventricular AutoCapture is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the ventricular pacing voltage until it determines that the device is no longer capturing the ventricles. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the ventricular pulse voltage and determines the ventricular threshold by viewing the EKG.', 'unitOfMeasure': 'Volts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, the first 43 CRT-D participants who successfully completed both an automatic and manual threshold in the left ventricle were included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CRT-D Device Patients', 'description': 'All patients with a cardiac resynchronization therapy device (CRT-D)enrolled in the study.'}, {'id': 'FG001', 'title': 'ICD Device Patients', 'description': 'All patients with an implantable cardioverter defibrillator (ICD) device enrolled in the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Removal of Device', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Patient relocated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment began in August 2008 at hospitals where patients were being implanted with implantable cardioverter defibrillators or in and physician offices where these patients were being followed. Recruitment was completed on April 1, 2009.', 'preAssignmentDetails': 'All patients who were enrolled in the study had the autocapture feature tested at each study visit, starting with at the implant visit when the study device was implanted.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Patients', 'description': 'All patients enrolled in the study'}], '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': '32', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '96', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cardiomyopathy', 'classes': [{'title': 'Ischemic Etiology', 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}]}]}, {'title': 'Non-Ischemic Etiology', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-01', 'studyFirstSubmitDate': '2008-09-02', 'resultsFirstSubmitDate': '2011-07-24', 'studyFirstSubmitQcDate': '2008-09-03', 'lastUpdatePostDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-02-20', 'studyFirstPostDateStruct': {'date': '2008-09-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Free of System-related Complications at 3-months Post Implant', 'timeFrame': '3 months post implant'}, {'measure': 'Atrial AutoCapture (ACap) Confirm Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test', 'timeFrame': '3 months post implant', 'description': 'Atrial AutoCapture Confirm is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the atrial pacing voltage until it determines that the device is no longer capturing the atria. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the atrial pulse voltage and determines the atrial threshold by viewing the EKG.'}, {'measure': 'Ventricular Autocapture Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test', 'timeFrame': '3 months post implant', 'description': 'Ventricular AutoCapture is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the ventricular pacing voltage until it determines that the device is no longer capturing the ventricles. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the ventricular pulse voltage and determines the ventricular threshold by viewing the EKG.'}, {'measure': 'Right Ventricular (RV) AutoCapture Effectiveness Endpoint - Difference Between the Automatic and Manual Capture Threshold Test', 'timeFrame': '3 months post implant', 'description': 'Right Ventricular AutoCapture is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the ventricular pacing voltage until it determines that the device is no longer capturing the ventricles. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the ventricular pulse voltage and determines the ventricular threshold by viewing the EKG.'}, {'measure': 'Left Ventricular (LV) AutoCapture Effectiveness Endpoint - Difference Between the Automatic and Manual Capture Threshold Test', 'timeFrame': '3 months post implant', 'description': 'Left Ventricular AutoCapture is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the ventricular pacing voltage until it determines that the device is no longer capturing the ventricles. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the ventricular pulse voltage and determines the ventricular threshold by viewing the EKG.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['heart failure', 'cardiac resynchronization therapy', 'autocapture', 'Current RF', 'Promote RF'], 'conditions': ['Heart Failure', 'Ventricular Arrythmias']}, 'descriptionModule': {'briefSummary': "This study is a prospective, non-randomized, multi-center clinical trial that will assess the safety and effectiveness of investigational models of the Promote™ RF CRT-D and Current™ RF ICD devices. These new ICD and CRT-D devices have new features that allow the device to periodically check how much energy is needed to pace a patient's heart and to automatically adjust the amount of energy used to pace the heart.", 'detailedDescription': "All patients enrolled in the study will have their device tested to determine if the device can automatically measure how much energy is needed to pace the patient's heart. If the test is successful, the patient's device will be programmed to turn that feature on. 3 months after enrollment, the patient will return to the clinic to have their device re-tested using an automatic test method to measure the amount of energy needed to make the patient's heart beat. A manual test method will also be used to measure the amount of energy needed to make the patient's heart beat. The intent of the study is to show the automatic method works just as well as the manual method."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have an approved indication, as outlined by American Heart Association/Heart Rhythm Society (AHA/HRS) guidelines, for implantation of an ICD or CRT-D for the treatment of life-threatening ventricular tachyarrhythmia(s) or heart failure, or undergo revision of their ICD or CRT-D system to replace the pulse generator.\n* Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.\n\nExclusion Criteria:\n\n* Have a classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 3 months.\n* Have had a recent myocardial infarction, unstable angina or cardiac revascularization (percutaneous transluminal coronary angioplasty (PTCA), Stent or Coronary Artery Bypass Graft(CABG)) within 40 days of enrollment.\n* Have had a recent cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months of enrollment.\n* Are allergic to dexamethasone sodium phosphate (DSP).\n* Be currently participating in a clinical investigation that includes an active treatment arm.\n* Be pregnant or are planning for pregnancy within 6 months following enrollment.\n* Have a life expectancy of less than 6 months.\n* Be less than 18 years of age.'}, 'identificationModule': {'nctId': 'NCT00746356', 'briefTitle': 'Safety and Efficacy of Automatic Testing Feature in New ICDs and CRT-Ds', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'A Clinical Evaluation of the Current™ Radio Frequency (RF) Implantable Cardioverter Defibrillator (ICD) Models 2215/1215 and Promote™ RF Cardiac Resynchronization Therapy Defibrillator (CRT-D) Model 3215 Pulse Generators', 'orgStudyIdInfo': {'id': '40005027'}, 'secondaryIdInfos': [{'id': 'IDE # G080060', 'type': 'OTHER', 'domain': 'FDA'}, {'id': 'Doc number 40005027', 'type': 'OTHER', 'domain': 'St. Jude Medical'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Promote RF CRT-D', 'description': 'Patients with CRT-D device will have the autocapture features of the device tested.', 'interventionNames': ['Device: Testing of the autocapture features of the device']}, {'type': 'EXPERIMENTAL', 'label': 'Current RF ICD', 'description': 'Patients with ICD device will have the autocapture features of the device tested.', 'interventionNames': ['Device: Testing of the autocapture features of the device']}], 'interventions': [{'name': 'Testing of the autocapture features of the device', 'type': 'DEVICE', 'description': 'Patients receiving cardiac resynchronization therapy will have new autocapture features tested on right atrial, right ventricular and left ventricular leads.', 'armGroupLabels': ['Promote RF CRT-D']}, {'name': 'Testing of the autocapture features of the device', 'type': 'DEVICE', 'description': 'Patients with an Implantable Cardioverter Defibrillator will have new autocapture features tested on the right atrial and right ventricular leads.', 'armGroupLabels': ['Current RF ICD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkanasas Heart Hospital', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '73305', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Baptist Health Hospital', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '08015', 'city': 'Browns Mills', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Deborah Heart and Lung Center', 'geoPoint': {'lat': 39.97261, 'lon': -74.58293}}, {'zip': '37205', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'St. Thomas Hospital', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Southwest Texas Methodist Hospital', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Tamara Shipman', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Director, Clinical Affairs, St. Jude Medical'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}