{ "FullStudy":{ "Rank":218038, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01513538", "OrgStudyIdInfo":{ "OrgStudyId":"TherapyGuide" }, "Organization":{ "OrgFullName":"Medtronic Bakken Research Center", "OrgClass":"INDUSTRY" }, "BriefTitle":"Analysis of the Acceptance and Changes to Parameters Programming Suggested by the TherapyGuide Function", "OfficialTitle":"TherapyGuide : Analysis of the Acceptance and Changes to Parameters Programming Suggested by the TherapyGuide Function" }, "StatusModule":{ "StatusVerifiedDate":"May 2017", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"May 2011", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"October 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"October 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 11, 2012", "StudyFirstSubmitQCDate":"January 16, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 20, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"May 25, 2016", "ResultsFirstSubmitQCDate":"May 22, 2017", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"December 18, 2017", "ResultsFirstPostDateType":"Actual" }, "LastUpdateSubmitDate":"May 22, 2017", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"December 18, 2017", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Medtronic Bakken Research Center", "LeadSponsorClass":"INDUSTRY" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Medtronic", "CollaboratorClass":"INDUSTRY" } ] } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The technological progress allowed the development of more and more sophisticated pacemakers, widening the therapeutic indications but also meeting the physiological needs of the patient. This progress led to a more and more complex programming for the physicians. To help them set optimally the pacing parameters, physicians refer to the existing recommendations of learned societies as well as to his expertise. Manufacturers developed also algorithms integrated into pacemakers with the aim of assisting physicians in their programming.\n\nTherapyGuide is a function which proposes a programming adapted to the psychopathological state of the patient, with a justification based on experts' consensus, clinical studies as well as on published articles.\n\nPhysicians have the choice to accept or reject the programming proposed by TherapyGuide. When rejected, there is no means to analyze the modifications brought to the proposed set of parameters. The nature, the frequency and the reasons of these modifications are not thus known.\n\nThe purpose of this study is to assess the acceptance of the TherapyGuide proposals by physicians and to identify the most frequent type of programming changes they make and their rationale." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Bradyarrhythmia" ] }, "KeywordList":{ "Keyword":[ "Pacemaker programming", "Bradyarrhythmia" ] } }, "DesignModule":{ "StudyType":"Observational", "DesignInfo":{ "DesignObservationalModelList":{ "DesignObservationalModel":[ "Case-Only" ] }, "DesignTimePerspectiveList":{ "DesignTimePerspective":[ "Prospective" ] } }, "EnrollmentInfo":{ "EnrollmentCount":"700", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"TherapyGuide", "ArmGroupDescription":"Patients implanted with a dual chamber pacemaker featuring the TherapyGuide function", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: TherapyGuide" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Device", "InterventionName":"TherapyGuide", "InterventionDescription":"Use of TherapyGuide function to help programming the device", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "TherapyGuide" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Acceptance of TherapyGuide Proposals and Typology of Programming Changes", "PrimaryOutcomeDescription":"The primary objective is to assess the acceptance of the TherapyGuide proposals by the physicians.\n\nAcceptance will be assessed by measuring the proportion of cases where physicians programmed the set of parameters recommended by the TherapyGuide with no modifications.", "PrimaryOutcomeTimeFrame":"30 months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nPatient implanted with a pacemaker featuring the TherapyGuide function\nPatient more than 18 years of age.\nPatient able to sign a data release authorization form\n\nExclusion Criteria:\n\n- Unwillingness or inability to provide written consent", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] }, "StudyPopulation":"Patients implanted with a dual chamber pacemaker featuring the TherapyGuide function", "SamplingMethod":"Non-Probability Sample" }, "ContactsLocationsModule":{ "LocationList":{ "Location":[ { "LocationFacility":"Clinique Bouchard", "LocationCity":"Marseille", "LocationZip":"13006", "LocationCountry":"France" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Patients Implanted With a Dual Chamber Pacemaker", "FlowGroupDescription":"All the enrolled patients were patients implanted with a dual chamber pacemaker with the Therapy Guide application : one-arm study." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowMilestoneComment":"Screening has been stopped after 578 patients agreed to participate to the study.", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"578" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"573" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"5" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"TherapyGuide", "BaselineGroupDescription":"Patients implanted with a dual chamber pacemaker featuring the TherapyGuide function\n\nTherapyGuide: Use of TherapyGuide function to help programming the device" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"578" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Customized", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Full Range", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Men", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"77", "BaselineMeasurementLowerLimit":"67", "BaselineMeasurementUpperLimit":"87" } ] } } ] } },{ "BaselineClassTitle":"Women", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"79", "BaselineMeasurementLowerLimit":"70", "BaselineMeasurementUpperLimit":"88" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex/Gender, Customized", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Men", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"347" } ] } } ] } },{ "BaselineClassTitle":"Women", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"231" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"France", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"578" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Acceptance of TherapyGuide Proposals and Typology of Programming Changes", "OutcomeMeasureDescription":"The primary objective is to assess the acceptance of the TherapyGuide proposals by the physicians.\n\nAcceptance will be assessed by measuring the proportion of cases where physicians programmed the set of parameters recommended by the TherapyGuide with no modifications.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of patients", "OutcomeMeasureTimeFrame":"30 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Patients Implanted With a Dual Chamber Pacemaker", "OutcomeGroupDescription":"All the patients were implanted with a dual chamber pacemaker with Therapy Guide function : one-arm study." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"573" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"46" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventsTimeFrame":"No adverse event collection.", "EventsDescription":"No adverse event collection.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Patients Implanted With a Dual Chamber Pacemaker", "EventGroupDescription":"All the patients were implanted with a dual chamber pacemaker with Therapy Guide function : one-arm study.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"0", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"0" } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"No", "AgreementRestrictiveAgreement":"No" }, "PointOfContact":{ "PointOfContactTitle":"Céline This", "PointOfContactOrganization":"Medtronic", "PointOfContactEMail":"celine.this@medtronic.com", "PointOfContactPhone":"33 6 89 71 90 67" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000001919", "ConditionMeshTerm":"Bradycardia" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000001145", "ConditionAncestorTerm":"Arrhythmias, Cardiac" },{ "ConditionAncestorId":"D000006331", "ConditionAncestorTerm":"Heart Diseases" },{ "ConditionAncestorId":"D000002318", "ConditionAncestorTerm":"Cardiovascular Diseases" },{ "ConditionAncestorId":"D000010335", "ConditionAncestorTerm":"Pathologic Processes" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M3778", "ConditionBrowseLeafName":"Bradycardia", "ConditionBrowseLeafAsFound":"Bradyarrhythmia", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M3034", "ConditionBrowseLeafName":"Arrhythmias, Cardiac", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8002", "ConditionBrowseLeafName":"Heart Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC14", "ConditionBrowseBranchName":"Heart and Blood Diseases" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }