{ "FullStudy":{ "Rank":217992, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01514162", "OrgStudyIdInfo":{ "OrgStudyId":"1003" }, "Organization":{ "OrgFullName":"Abbott Medical Devices", "OrgClass":"INDUSTRY" }, "BriefTitle":"Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve", "OfficialTitle":"Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve" }, "StatusModule":{ "StatusVerifiedDate":"January 2019", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"February 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"October 2014", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"October 2014", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 17, 2012", "StudyFirstSubmitQCDate":"January 17, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 20, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"October 14, 2016", "ResultsFirstSubmitQCDate":"May 2, 2017", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"May 31, 2017", "ResultsFirstPostDateType":"Actual" }, "LastUpdateSubmitDate":"January 31, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"February 15, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Abbott Medical Devices", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"To further evaluate the long term clinical safety and effectiveness of the Trifecta valve", "DetailedDescription":"To further evaluate the long term clinical safety and effectiveness of the Trifecta valve in subjects who had a Trifecta valve implanted during the IDE study." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Heart Valve Diseases" ] }, "KeywordList":{ "Keyword":[ "Trifecta Valve" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"245", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Trifecta Valve Group", "ArmGroupType":"Experimental", "ArmGroupDescription":"Subjects implanted with a Trifecta valve.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: Trifecta valve" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Device", "InterventionName":"Trifecta valve", "InterventionDescription":"surgical replacement of aortic valve", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Trifecta Valve Group" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Late Adverse Event Incidence", "PrimaryOutcomeDescription":"Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events.\n\nLate Patient year calculation:[(Number of late adverse events/sum of late patient years) x 100]", "PrimaryOutcomeTimeFrame":"5 years" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Characterize Patient NYHA Functional Classification Status", "SecondaryOutcomeDescription":"The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.\n\nClass I. Patients with cardiac disease but without resulting limitation of physical activity.\n\nClass II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.\n\nClass III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.\n\nClass IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.\n\nThe Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256.", "SecondaryOutcomeTimeFrame":"5 years" },{ "SecondaryOutcomeMeasure":"Report the Hemodynamic Performance of the Valve", "SecondaryOutcomeDescription":"Gradient is the pressure difference from one side of the valve to the other side of the valve. For this study pressure is measured in mmHg.\n\nMean gradient for each patient is the average of the pressure differences from one side of the valve to the other side of the valve.\n\nMean gradient for each valve size (19mm, 21mm, 23mm, 25mm, 27mm, 29mm)is the average of the mean gradient for each patient with that valve size.", "SecondaryOutcomeTimeFrame":"5 years" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nSubjects implanted with a Trifecta valve at one of the US sites of the IDE study.\nSubject met eligibility criteria of IDE study\nSubject agrees to complete study follow-up visits\nSubject provides written informed consent\n\nExclusion Criteria:\n\nSubject currently participating in another device or drug study\nSubject unable or unwilling to return for study follow-up visits", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "LocationList":{ "Location":[ { "LocationFacility":"Abbott Northwestern Hospital Cardiac Surgical Associates", "LocationCity":"Minneapolis", "LocationState":"Minnesota", "LocationZip":"55407", "LocationCountry":"United States" },{ "LocationFacility":"Mayo Clinic", "LocationCity":"Rochester", "LocationState":"Minnesota", "LocationZip":"55905", "LocationCountry":"United States" },{ "LocationFacility":"Mission Hospital", "LocationCity":"Asheville", "LocationState":"North Carolina", "LocationZip":"28801", "LocationCountry":"United States" },{ "LocationFacility":"Hospital of the University of Pennsylvania", "LocationCity":"Philadelphia", "LocationState":"Pennsylvania", "LocationZip":"19104", "LocationCountry":"United States" },{ "LocationFacility":"Vanderbilt Heart Institute", "LocationCity":"Nashville", "LocationState":"Tennessee", "LocationZip":"37232", "LocationCountry":"United States" },{ "LocationFacility":"Intermountain Heart & Lung Surgical Associates", "LocationCity":"Murray", "LocationState":"Utah", "LocationZip":"84157", "LocationCountry":"United States" } ] } }, "IPDSharingStatementModule":{ "IPDSharing":"No" } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Trifecta Valve Group", "FlowGroupDescription":"Subjects implanted with a Trifecta valve." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"245" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"160" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"85" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Trifecta Valve Group", "BaselineGroupDescription":"Subjects implanted with a Trifecta valve." } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"245" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Categorical", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"<=18 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Between 18 and 65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"45" } ] } },{ "BaselineCategoryTitle":">=65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"200" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"72", "BaselineMeasurementSpread":"8.4" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"73" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"172" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"United States", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"245" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Late Adverse Event Incidence", "OutcomeMeasureDescription":"Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events.\n\nLate Patient year calculation:[(Number of late adverse events/sum of late patient years) x 100]", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"event/100-patient years", "OutcomeMeasureTimeFrame":"5 years", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Trifecta Valve Group", "OutcomeGroupDescription":"Subjects implanted with a Trifecta valve." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"245" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Thromboembolism", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7" } ] } } ] } },{ "OutcomeClassTitle":"Valve thrombosis", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Nonstructural Dysfunction", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Structural Deterioration", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4" } ] } } ] } },{ "OutcomeClassTitle":"Mortality", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"9" } ] } } ] } },{ "OutcomeClassTitle":"Endocarditis", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Characterize Patient NYHA Functional Classification Status", "OutcomeMeasureDescription":"The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.\n\nClass I. Patients with cardiac disease but without resulting limitation of physical activity.\n\nClass II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.\n\nClass III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.\n\nClass IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.\n\nThe Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256.", "OutcomeMeasurePopulationDescription":"Number of participants analyzed is those subjects with a visit and completed assessment", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"5 years", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Trifecta Valve Group", "OutcomeGroupDescription":"Subjects implanted with a Trifecta valve." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"189" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"NYHA I", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"171" } ] } } ] } },{ "OutcomeClassTitle":"NYHA II", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"16" } ] } } ] } },{ "OutcomeClassTitle":"NYHA III", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"NYHA IV", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Report the Hemodynamic Performance of the Valve", "OutcomeMeasureDescription":"Gradient is the pressure difference from one side of the valve to the other side of the valve. For this study pressure is measured in mmHg.\n\nMean gradient for each patient is the average of the pressure differences from one side of the valve to the other side of the valve.\n\nMean gradient for each valve size (19mm, 21mm, 23mm, 25mm, 27mm, 29mm)is the average of the mean gradient for each patient with that valve size.", "OutcomeMeasurePopulationDescription":"Aortic valve mean gradient at 5 years for participants analyzed with a visit and completed assessment", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"mmHg", "OutcomeMeasureTimeFrame":"5 years", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Trifecta Valve Group", "OutcomeGroupDescription":"Subjects implanted with a Trifecta valve." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"176" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"19mm", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"15.4", "OutcomeMeasurementSpread":"5.9" } ] } } ] } },{ "OutcomeClassTitle":"21mm", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"10.4", "OutcomeMeasurementSpread":"5.6" } ] } } ] } },{ "OutcomeClassTitle":"23mm", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"9.2", "OutcomeMeasurementSpread":"4.9" } ] } } ] } },{ "OutcomeClassTitle":"25mm", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7.9", "OutcomeMeasurementSpread":"3.7" } ] } } ] } },{ "OutcomeClassTitle":"27mm", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"8.4", "OutcomeMeasurementSpread":"8.8" } ] } } ] } },{ "OutcomeClassTitle":"29mm", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6.1", "OutcomeMeasurementSpread":"2.3" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Trifecta Valve Group", "EventGroupDescription":"Subjects implanted with a Trifecta valve.", "EventGroupSeriousNumAffected":"39", "EventGroupSeriousNumAtRisk":"245", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"245" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Thromboembolism", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"9", "SeriousEventStatsNumAffected":"9", "SeriousEventStatsNumAtRisk":"245" } ] } },{ "SeriousEventTerm":"Valve thrombosis", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"245" } ] } },{ "SeriousEventTerm":"Major bleed", "SeriousEventOrganSystem":"Vascular disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"24", "SeriousEventStatsNumAffected":"24", "SeriousEventStatsNumAtRisk":"245" } ] } },{ "SeriousEventTerm":"Nonstructural dysfunction", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"245" } ] } },{ "SeriousEventTerm":"Endocarditis", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"245" } ] } },{ "SeriousEventTerm":"Clinically significant hemolysis", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"245" } ] } },{ "SeriousEventTerm":"Structural deterioration", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"4", "SeriousEventStatsNumAffected":"4", "SeriousEventStatsNumAtRisk":"245" } ] } },{ "SeriousEventTerm":"Reoperation", "SeriousEventOrganSystem":"Surgical and medical procedures", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"245" } ] } },{ "SeriousEventTerm":"Valve related mortality", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"245" } ] } } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"No", "AgreementRestrictionType":"OTHER", "AgreementRestrictiveAgreement":"Yes" }, "PointOfContact":{ "PointOfContactTitle":"Jennifer Johnson", "PointOfContactOrganization":"St Jude Medical", "PointOfContactEMail":"jjohnson101@sjm.com", "PointOfContactPhone":"6517566803" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000006349", "ConditionMeshTerm":"Heart Valve Diseases" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000006331", "ConditionAncestorTerm":"Heart Diseases" },{ "ConditionAncestorId":"D000002318", "ConditionAncestorTerm":"Cardiovascular Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M8020", "ConditionBrowseLeafName":"Heart Valve Diseases", "ConditionBrowseLeafAsFound":"Heart Valve Diseases", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M8002", "ConditionBrowseLeafName":"Heart Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC14", "ConditionBrowseBranchName":"Heart and Blood Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }