{ "FullStudy":{ "Rank":218259, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01510652", "OrgStudyIdInfo":{ "OrgStudyId":"CR-11-006-HF-ID" }, "Organization":{ "OrgFullName":"Abbott Medical Devices", "OrgClass":"INDUSTRY" }, "BriefTitle":"More Options Available With a Quadripolar LV Lead pRovidE In-clinic Solutions to CRT Challenges", "OfficialTitle":"More Options Available With a Quadripolar Left Ventricular (LV) Lead pRovidE In-clinic Solutions to Cardiac Resynchronization Therapy (CRT) Challenges", "Acronym":"MORE-CRT" }, "StatusModule":{ "StatusVerifiedDate":"January 2019", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"November 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"May 2014", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"May 2014", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"November 30, 2011", "StudyFirstSubmitQCDate":"January 11, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 16, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"August 14, 2015", "ResultsFirstSubmitQCDate":"September 23, 2015", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"October 23, 2015", "ResultsFirstPostDateType":"Estimate" }, "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":"This investigation is designed with the hypothesis that using a quadripolar left ventricular lead results in less interventions when dealing with high pacing thresholds and Phrenic Nerve Stimulation (PNS), both at implant and during follow-up, compared to standard bipolar left ventricular leads." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Postoperative Cardiac Complication", "Heart Failure", "Left Ventricular Cardiac Dysfunction", "Inappropriate Phrenic Nerve Stimulation", "Perioperative/Postoperative Complications" ] }, "KeywordList":{ "Keyword":[ "Cardiac Resynchronization therapy,", "Heart Failure,", "Left Ventricular Lead,", "Quadripolar Left ventricular Lead,", "Phrenic Nerve Stimulation,", "Intra and post operative related complications" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Prevention", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"1078", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Quad Group", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: Quad Group" ] } },{ "ArmGroupLabel":"BiP Group", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Procedure: BiP Group" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Procedure", "InterventionName":"BiP Group", "InterventionDescription":"Implantation of standard Left Ventricular (LV) lead", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "BiP Group" ] } },{ "InterventionType":"Device", "InterventionName":"Quad Group", "InterventionDescription":"Implantation of quadripolar Left ventricular (LV) lead Quartet", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Quad Group" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Lead Performance", "PrimaryOutcomeDescription":"Percentage of patients with freedom from event (intra- and post-operative). Intra-operative events were defined as: need to use more than 1 left ventricular lead, need to change lead implant position, use of any device to actively fixate the lead, unsuccessful implant, due to phrenic nerve stimulation, high pacing threshold or lead instability.\n\nPost-operative events were defined as any left ventricular lead related serious adverse device effect and CRT switched off.", "PrimaryOutcomeTimeFrame":"6 months" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Percentage of Cardiac Resynchronization Therapy Responders", "SecondaryOutcomeDescription":"Percentage of Cardiac Resynchronization Therapy (CRT) responders measured by a decrease of at least 10% of Left Ventricle End-Systolic Volume (LVESV)", "SecondaryOutcomeTimeFrame":"Baseline and 6 months" },{ "SecondaryOutcomeMeasure":"Implant Duration", "SecondaryOutcomeDescription":"This measure reports the length (in time) of the implantation procedure. The measurement start at skin incision and stop at skin suture (so called skin-to-skin time) The total implant procedure duration time will be compared between the control and the treatment group.", "SecondaryOutcomeTimeFrame":"Total duration of the implant procedure reported at the end of the procedure" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nPatients are indicated for Cardiac Resynchronization Therapy with Defibrillation backup device (CRT-D) implantation, as per current international certified guidelines\nPatients age is 18 years or greater\nPatients must indicate their understanding of the study and willingness to participate by signing the appropriate informed consent form\nPatients must be willing and able to comply with all study requirements\n\nExclusion Criteria:\n\nPatients with a life expectancy <12 months.\nPatients who are or may potentially be pregnant.\n\nPatient has suffered any of the following in the 4 weeks prior to enrolment:\n\nMyocardial Infarction (MI)\nCoronary Artery Bypass Graft (CABG)\nUnstable Angina Pectoris\nPatient has primary valvular disease which has not been corrected", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Giuseppe Boriani, Pro.", "OverallOfficialAffiliation":"Policlinico Universitario S. Orsola e Malpighi, Bologna, Italy", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Ziekenhuis Oost-Limburg", "LocationCity":"Genk", "LocationCountry":"Belgium" },{ "LocationFacility":"Hopital La Citadelle", "LocationCity":"Liège", "LocationCountry":"Belgium" },{ "LocationFacility":"Foothills Medical Center", "LocationCity":"Calgary", "LocationCountry":"Canada" },{ "LocationFacility":"Royal Alexandra Hospital", "LocationCity":"Edmonton", "LocationCountry":"Canada" },{ "LocationFacility":"QE II Health Sciences", "LocationCity":"Halifax", "LocationCountry":"Canada" },{ "LocationFacility":"Institut de Cardiologie du Quebec - Hopital Laval", "LocationCity":"Quebec", "LocationCountry":"Canada" },{ "LocationFacility":"HSC Heastern Health", "LocationCity":"St. Johns", "LocationCountry":"Canada" },{ "LocationFacility":"Paijat-Hame Central Hospital", "LocationCity":"Lahti", "LocationCountry":"Finland" },{ "LocationFacility":"Tampere University Hospital", "LocationCity":"Tampere", "LocationCountry":"Finland" },{ "LocationFacility":"CHU La Cavale Blanche", "LocationCity":"Brest", "LocationCountry":"France" },{ "LocationFacility":"CHU Gabriel Montpied", "LocationCity":"Clermont-Ferrand", "LocationCountry":"France" },{ "LocationFacility":"CHRU Hopital Albert Michallon", "LocationCity":"Grenoble", "LocationCountry":"France" },{ "LocationFacility":"Hopital Cardiovasculaire et Pneumologique Louis Pradel", "LocationCity":"Lyon", "LocationCountry":"France" },{ "LocationFacility":"Hopital de la Timone", "LocationCity":"Marseille", "LocationCountry":"France" },{ "LocationFacility":"Hopital du Nord - CH Bourrely St. Antoine", "LocationCity":"Marseille", "LocationCountry":"France" },{ "LocationFacility":"CHU Hopital G&R Laennec", "LocationCity":"Nantes", "LocationCountry":"France" },{ "LocationFacility":"Nouvelles Cliniques Nantaises", "LocationCity":"Nantes", "LocationCountry":"France" },{ "LocationFacility":"CHRU Hopital de Pontchaillou", "LocationCity":"Rennes", "LocationCountry":"France" },{ "LocationFacility":"CHRU Hopital Charles Nicolle", "LocationCity":"Rouen", "LocationCountry":"France" },{ "LocationFacility":"CHU St. Etienne", "LocationCity":"Saint Priest en Jarez", "LocationCountry":"France" },{ "LocationFacility":"Clinique du Tonkin", "LocationCity":"Villeurbanne", "LocationCountry":"France" },{ "LocationFacility":"Charite Campus Virchow Klinikum", "LocationCity":"Berlin", "LocationCountry":"Germany" },{ "LocationFacility":"Unfallkrankenhaus Berlin-Marzahn", "LocationCity":"Berlin", "LocationCountry":"Germany" },{ "LocationFacility":"Stadtische Kliniken Bielefeld", "LocationCity":"Bielefeld", "LocationCountry":"Germany" },{ "LocationFacility":"Klinikum Coburg", "LocationCity":"Coburg", "LocationCountry":"Germany" },{ "LocationFacility":"Elisabeth-Krankenhaus", "LocationCity":"Essen", "LocationCountry":"Germany" },{ "LocationFacility":"Universitatsklinikum Greifswald", "LocationCity":"Greifswald", "LocationCountry":"Germany" },{ "LocationFacility":"Universitatskliniken des Saarlandes", "LocationCity":"Homburg", "LocationCountry":"Germany" },{ "LocationFacility":"Universitatsklinikum Leipzig", "LocationCity":"Leipzig", "LocationCountry":"Germany" },{ "LocationFacility":"Klinikum Ludenscheid", "LocationCity":"Ludenscheid", "LocationCountry":"Germany" },{ "LocationFacility":"Stadtisches Klinikum Ludwigshafen", "LocationCity":"Ludwigshafen", "LocationCountry":"Germany" },{ "LocationFacility":"Krankenhaus der Barmherzigen", "LocationCity":"Trier", "LocationCountry":"Germany" },{ "LocationFacility":"All India Institute of Medical Sciences", "LocationCity":"New Delhi", "LocationCountry":"India" },{ "LocationFacility":"Escorts Heart Institute and Research Center", "LocationCity":"New Delhi", "LocationCountry":"India" },{ "LocationFacility":"Barzilai Medical Center", "LocationCity":"Ashkelon", "LocationCountry":"Israel" },{ "LocationFacility":"Soroka University Hospital", "LocationCity":"Beer Sheba", "LocationCountry":"Israel" },{ "LocationFacility":"Kaplan Medical Center", "LocationCity":"Rehovot", "LocationCountry":"Israel" },{ "LocationFacility":"Sheba Medical Center", "LocationCity":"Tel Hashomer", "LocationCountry":"Israel" },{ "LocationFacility":"Policlinico S. Orsola & Malpighi", "LocationCity":"Bologna", "LocationCountry":"Italy" },{ "LocationFacility":"Azienda Ospedaliera S.Anna e S.Sebastiano", "LocationCity":"Caserta", "LocationCountry":"Italy" },{ "LocationFacility":"Azienda Ospedaliera Mater Domini", "LocationCity":"Catanzaro", "LocationCountry":"Italy" },{ "LocationFacility":"Ospedale Vito Fazzi", "LocationCity":"Lecce", "LocationCountry":"Italy" },{ "LocationFacility":"Ospedale Maggiore della Carità", "LocationCity":"Novara", "LocationCountry":"Italy" },{ "LocationFacility":"Policlinico Casilino", "LocationCity":"Rome", "LocationCountry":"Italy" },{ "LocationFacility":"Ospedale SS. Annunziata", "LocationCity":"Taranto", "LocationCountry":"Italy" },{ "LocationFacility":"Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista", "LocationCity":"Torino", "LocationCountry":"Italy" },{ "LocationFacility":"Ospedale Civile Maggiore Verona Borgo Trento", "LocationCity":"Verona", "LocationCountry":"Italy" },{ "LocationFacility":"Amphia Hospital", "LocationCity":"Breda", "LocationCountry":"Netherlands" },{ "LocationFacility":"Haga Ziekenhuis", "LocationCity":"Den Haag", "LocationCountry":"Netherlands" },{ "LocationFacility":"MC Haaglanden", "LocationCity":"Den Haag", "LocationCountry":"Netherlands" },{ "LocationFacility":"Medisch Spectrum Twente", "LocationCity":"Enschede", "LocationCountry":"Netherlands" },{ "LocationFacility":"Slaskie Centrum Chorob Serca", "LocationCity":"Zabrze", "LocationCountry":"Poland" },{ "LocationFacility":"Hospital de Basurto", "LocationCity":"Bilbao", "LocationCountry":"Spain" },{ "LocationFacility":"Hospital Ramon y Cajal", "LocationCity":"Madrid", "LocationCountry":"Spain" },{ "LocationFacility":"Hospital Universitari La Fe", "LocationCity":"Valencia", "LocationCountry":"Spain" },{ "LocationFacility":"Basel University Hospital", "LocationCity":"Basel", "LocationCountry":"Switzerland" },{ "LocationFacility":"Hopital Cantonal Universitaire de Geneva", "LocationCity":"Geneva", "LocationCountry":"Switzerland" },{ "LocationFacility":"Fondazione Cardiocentro Ticino", "LocationCity":"Lugano", "LocationCountry":"Switzerland" },{ "LocationFacility":"Universitaets Spital Zuerich", "LocationCity":"Zurich", "LocationCountry":"Switzerland" },{ "LocationFacility":"Queen Elizabeth Hospital", "LocationCity":"Birmingham", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Royal Bournemouth Hospital", "LocationCity":"Bournemouth", "LocationCountry":"United Kingdom" },{ "LocationFacility":"University Hospital of Wales", "LocationCity":"Cardiff", "LocationCountry":"United Kingdom" },{ "LocationFacility":"St. Thomas Hospital", "LocationCity":"London", "LocationCountry":"United Kingdom" },{ "LocationFacility":"James Cook University Hospital", "LocationCity":"Middlesbrough", "LocationCountry":"United Kingdom" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"29766873", "ReferenceType":"derived", "ReferenceCitation":"Boriani G, Connors S, Kalarus Z, Lemke B, Mullens W, Osca Asensi J, Raatikainen P, Gazzola C, Farazi TG, Leclercq C. Cardiac Resynchronization Therapy With a Quadripolar Electrode Lead Decreases Complications at 6 Months: Results of the MORE-CRT Randomized Trial. JACC Clin Electrophysiol. 2016 Apr;2(2):212-220. doi: 10.1016/j.jacep.2015.10.004. Epub 2015 Nov 11." } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"1078 patients have been enrolled in this study, while 1074 have been randomized to Quad or BiP group.\n\nThe randomization procedure happened after the enrollment and before the implant, this explains why not all 1078 patients have been randomized", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Quad Group", "FlowGroupDescription":"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet\n\nQuartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"BiP Group", "FlowGroupDescription":"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)\n\nStandard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"719" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"355" } ] } },{ "FlowMilestoneType":"Baseline", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"718" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"348" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"627" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"288" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"92" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"67" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Quad Group", "BaselineGroupDescription":"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet\n\nQuartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"BiP Group", "BaselineGroupDescription":"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)\n\nStandard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"718" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"348" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"1066" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"67.6", "BaselineMeasurementSpread":"10.2" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"68.4", "BaselineMeasurementSpread":"9.7" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"67.9", "BaselineMeasurementSpread":"10.1" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"173" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"74" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"247" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"545" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"274" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"819" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Left Ventricular Ejection Fraction (LVEF)", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"%", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"27.1", "BaselineMeasurementSpread":"7.6" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"27.5", "BaselineMeasurementSpread":"8.1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"27.2", "BaselineMeasurementSpread":"7.7" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Left Ventricular End-Diastolic Volume (LVEDV)", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"ml", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"200.4", "BaselineMeasurementSpread":"74.9" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"204.5", "BaselineMeasurementSpread":"72.0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"203.2", "BaselineMeasurementSpread":"80.6" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Left Ventricular End-Systolic Volume (LVESV)", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"ml", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"151.2", "BaselineMeasurementSpread":"64.0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"149.0", "BaselineMeasurementSpread":"58.3" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"150.5", "BaselineMeasurementSpread":"62.2" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"QRS duration", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"ms", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"158", "BaselineMeasurementSpread":"29" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"157", "BaselineMeasurementSpread":"27" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"157.5", "BaselineMeasurementSpread":"28.4" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Cardiomyopathy", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Ischemic", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"353" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"196" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"549" } ] } } ] } },{ "BaselineClassTitle":"Non Ischemic", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"365" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"152" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"517" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Atrial Arrhythmia History", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Atrial Fibrillation", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"114" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"58" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"172" } ] } } ] } },{ "BaselineClassTitle":"Atrial Flutter", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"21" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"28" } ] } } ] } },{ "BaselineClassTitle":"None", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"583" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"283" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"866" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Lead Performance", "OutcomeMeasureDescription":"Percentage of patients with freedom from event (intra- and post-operative). Intra-operative events were defined as: need to use more than 1 left ventricular lead, need to change lead implant position, use of any device to actively fixate the lead, unsuccessful implant, due to phrenic nerve stimulation, high pacing threshold or lead instability.\n\nPost-operative events were defined as any left ventricular lead related serious adverse device effect and CRT switched off.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"% of patients with freedom from event", "OutcomeMeasureTimeFrame":"6 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Quad Group", "OutcomeGroupDescription":"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet\n\nQuartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"BiP Group", "OutcomeGroupDescription":"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)\n\nStandard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"719" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"355" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"83" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"74.4" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Cardiac Resynchronization Therapy Responders", "OutcomeMeasureDescription":"Percentage of Cardiac Resynchronization Therapy (CRT) responders measured by a decrease of at least 10% of Left Ventricle End-Systolic Volume (LVESV)", "OutcomeMeasurePopulationDescription":"The number of participants analyzed is the number of patients with echo data received for both baseline and 6 months follow up visits (and so comparable)", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"% of patients that are CRT responders", "OutcomeMeasureTimeFrame":"Baseline and 6 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Quad Group", "OutcomeGroupDescription":"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet\n\nQuartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"BiP Group", "OutcomeGroupDescription":"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)\n\nStandard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"476" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"218" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"62.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"56.0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Implant Duration", "OutcomeMeasureDescription":"This measure reports the length (in time) of the implantation procedure. The measurement start at skin incision and stop at skin suture (so called skin-to-skin time) The total implant procedure duration time will be compared between the control and the treatment group.", "OutcomeMeasurePopulationDescription":"The number of participants analyzed is the number of patients with implant data duration time available.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"min", "OutcomeMeasureTimeFrame":"Total duration of the implant procedure reported at the end of the procedure", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Quad Group", "OutcomeGroupDescription":"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet\n\nQuartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"BiP Group", "OutcomeGroupDescription":"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)\n\nStandard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"710" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"342" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"100.4", "OutcomeMeasurementSpread":"54.5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"101.1", "OutcomeMeasurementSpread":"51" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventsTimeFrame":"6 Months: From the enrollment to 6 Months Follow Up", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Quad Group", "EventGroupDescription":"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet\n\nQuartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet", "EventGroupSeriousNumAffected":"332", "EventGroupSeriousNumAtRisk":"719", "EventGroupOtherNumAffected":"186", "EventGroupOtherNumAtRisk":"719" },{ "EventGroupId":"EG001", "EventGroupTitle":"BiP Group", "EventGroupDescription":"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)\n\nStandard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead", "EventGroupSeriousNumAffected":"211", "EventGroupSeriousNumAtRisk":"355", "EventGroupOtherNumAffected":"76", "EventGroupOtherNumAtRisk":"355" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Arrhythmia", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"55", "SeriousEventStatsNumAffected":"53", "SeriousEventStatsNumAtRisk":"719" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"35", "SeriousEventStatsNumAffected":"35", "SeriousEventStatsNumAtRisk":"355" } ] } },{ "SeriousEventTerm":"Bleeding", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"719" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"355" } ] } },{ "SeriousEventTerm":"Dyspnea", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"719" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"5", "SeriousEventStatsNumAffected":"5", "SeriousEventStatsNumAtRisk":"355" } ] } },{ "SeriousEventTerm":"Heart Failure", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"55", "SeriousEventStatsNumAffected":"41", "SeriousEventStatsNumAtRisk":"719" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"30", "SeriousEventStatsNumAffected":"24", "SeriousEventStatsNumAtRisk":"355" } ] } },{ "SeriousEventTerm":"Hematoma", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"16", "SeriousEventStatsNumAffected":"16", "SeriousEventStatsNumAtRisk":"719" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"9", "SeriousEventStatsNumAffected":"9", "SeriousEventStatsNumAtRisk":"355" } ] } },{ "SeriousEventTerm":"Infection", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"24", 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"SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"7", "SeriousEventStatsNumAffected":"7", "SeriousEventStatsNumAtRisk":"719" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"355" } ] } },{ "SeriousEventTerm":"Pulmonary Edema", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"6", "SeriousEventStatsNumAffected":"5", "SeriousEventStatsNumAtRisk":"719" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"8", "SeriousEventStatsNumAffected":"8", "SeriousEventStatsNumAtRisk":"355" } ] } },{ "SeriousEventTerm":"Other - Non Cardiac", "SeriousEventOrganSystem":"General disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ 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"OtherEventTerm":"Pneumothorax", "OtherEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"719" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"355" } ] } },{ "OtherEventTerm":"Other - Non Cardiac", "OtherEventOrganSystem":"General disorders", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"43", "OtherEventStatsNumAffected":"42", "OtherEventStatsNumAtRisk":"719" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"16", "OtherEventStatsNumAffected":"16", "OtherEventStatsNumAtRisk":"355" } ] } },{ "OtherEventTerm":"Cardiac Perforation (Other 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