{ "FullStudy":{ "Rank":217870, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01515761", "OrgStudyIdInfo":{ "OrgStudyId":"PIIT1A" }, "Organization":{ "OrgFullName":"Southern Arizona VA Health Care System", "OrgClass":"FED" }, "BriefTitle":"POsition of Leads in Advanced heaRt Failure: the POLAR Study", "OfficialTitle":"POsition of Leads in Advanced heaRt Failure: the POLAR Study - A 6 Month, Observational, Mult-centered, Blinded, Randomized Study to Determine if Lead Positioning in the Lateral Wall of LV in Patients Meeting Criteria for CRT Plays a Role in Determining Myocardial Function and Affect the Severity of Mitral Regurgitation", "Acronym":"POLAR" }, "StatusModule":{ "StatusVerifiedDate":"January 2012", "OverallStatus":"Unknown status", "LastKnownStatus":"Recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"September 2010" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"March 2013", "PrimaryCompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 12, 2012", "StudyFirstSubmitQCDate":"January 23, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 24, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 23, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 24, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor-Investigator", "ResponsiblePartyInvestigatorFullName":"Sergio Thal, M.D.", "ResponsiblePartyInvestigatorTitle":"Electrophyisology Laboratory Director", "ResponsiblePartyInvestigatorAffiliation":"Southern Arizona VA Health Care System" }, "LeadSponsor":{ "LeadSponsorName":"Sergio Thal, M.D.", "LeadSponsorClass":"FED" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Medtronic", "CollaboratorClass":"INDUSTRY" },{ "CollaboratorName":"Lexington VA Medical Center", "CollaboratorClass":"FED" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The primary objective is to determine if lead positioning in the lateral wall of the left ventricle in patients meeting criteria for cardiac resynchronization therapy plays a role in determining myocardial function and affects the severity of mitral regurgitation.", "DetailedDescription":"This is a 6 month, multi-centered, blinded, randomized study. Approximately 60 patients will join this study. Two groups, based on lead position, will be studied with thirty (30) patients randomized into each group." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Cardiac Resynchronization Therapy", "Heart Failure" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Triple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"60", "EnrollmentType":"Anticipated" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Postero-lateral", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Left ventricular lateral wall lead position", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Procedure: Postero-lateral" ] } },{ "ArmGroupLabel":"Antero-lateral", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Left ventricular lateral wall lead position", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Procedure: Antero-Lateral" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Procedure", "InterventionName":"Postero-lateral", "InterventionDescription":"A device implant procedure will be performed under the standard of care technique with the right ventricular lead at the right ventricular apex and the left ventricular lead targeting or postero-lateral area of the LV based on pre-procedure randomization.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Postero-lateral" ] } },{ "InterventionType":"Procedure", "InterventionName":"Antero-Lateral", "InterventionDescription":"A device implant procedure will be performed under the standard of care technique with the right ventricular lead at the right ventricular apex and the left ventricular lead targeting or antero-lateral area of the LV based on pre-procedure randomization.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Antero-lateral" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change (reduction) in left ventricular end systolic volume (LVESV)", "PrimaryOutcomeTimeFrame":"3 and 6 months" },{ "PrimaryOutcomeMeasure":"Change in 6 minute walk tests", "PrimaryOutcomeTimeFrame":"6 weeks, 3 and 6 months" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Myocardial performance as measured by myocardial performance index (MPI)", "SecondaryOutcomeTimeFrame":"6 months" },{ "SecondaryOutcomeMeasure":"Papillary muscle velocity as determined by tissue doppler", "SecondaryOutcomeTimeFrame":"6 months" },{ "SecondaryOutcomeMeasure":"Progression of mitral regurgitation", "SecondaryOutcomeDescription":"as measured by regurgitant volume, mitral regurgitation fraction and effective regurgitant orifice area", "SecondaryOutcomeTimeFrame":"6 months" },{ "SecondaryOutcomeMeasure":"Minnesota living heart failure survey", "SecondaryOutcomeTimeFrame":"6 weeks, 3 and 6 months" },{ "SecondaryOutcomeMeasure":"Chronic heart failure hospitalizations", "SecondaryOutcomeTimeFrame":"Monitored during study participation ~ 6 months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nSubject meets the general indications for an implantable cardioverter defibrillator (ICD) with LV systolic function ≤ 35% as defined by echocardiography.\nSubject has moderate or severe heart failure, defined as NYHA Class III-IV for at least 90 days prior to enrollment.\nSubject has optimal pharmacological heart failure therapy for at least 30 days prior to enrollment.\nSubject has a 12-lead electrocardiogram (ECG) obtained no more than 90 days prior to enrollment documenting a sinus rate > 50 bpm and PR interval < 320 ms measured from any two leads.\n12 lead ECG with left bundle brunch block morphology and a QRS duration of at least 120 msec.\nSubject has creatinine < 2.5 mg/dL obtained no more than 30 days prior to enrollment.\nSubject has left ventricular ejection fraction < 35% by echocardiogram no more than 1 year prior to enrollment.\nSubject is willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation.\nSubject has a life expectancy of more than 180 days, per physician discretion.\nSubject is age 18 or above, or of legal age to give informed consent specific to state and national law.\n\nExclusion Criteria:\n\nSubject has right bundle branch block morphology on a 12-lead ECG obtained no more than 90 days prior to enrollment.\nSubject had previous cardiac resynchronization therapy, a previous coronary venous lead, or meets the general indications for anti-bradycardia pacing defined as ventricular pacing > 40% by pacemaker interrogation.\nSubject has a neuromuscular, orthopedic, or other non-cardiac condition that prevents normal, unsupported walking.\nSubject has an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) or persistent (i.e., can be terminated with medical intervention, but does not terminate spontaneously) within 30 days prior to enrollment.\nSubject currently requires dialysis.\nSubject has severe chronic obstructive pulmonary disease (COPD), defined as FEV1/FVC < 60%, or as defined by a physician.\nSubject has had a myocardial infarction within 30 days prior to enrollment or coronary artery disease (CAD) in which surgical or percutaneous correction was performed within 30 days prior to enrollment.\nSubject has hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis).\nSubject is on IV inotropic agents.\nSubject has any mitral valve prosthesis, or a mechanical aortic or tricuspid prosthesis\nSubject is enrolled in any concurrent study, without Medtronic written approval, which may confound the results of this study.\nSubject is pregnant or planning to get pregnant.\nSubject requires oxygen for medical reasons other than CHF.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "CentralContactList":{ "CentralContact":[ { "CentralContactName":"Sergio Thal, M.D.", "CentralContactRole":"Contact", "CentralContactPhone":"520-792-1450", "CentralContactPhoneExt":"4624", "CentralContactEMail":"sergio.thal@va.gov" },{ "CentralContactName":"Elizabeth Juneman, M.D.", "CentralContactRole":"Contact", "CentralContactPhone":"520-792-1450", "CentralContactPhoneExt":"4624", "CentralContactEMail":"elizabeth.juneman@va.gov" } ] }, "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Sergio Thal, M.D.", "OverallOfficialAffiliation":"Southern Arizona VA Health Care System", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Southern Arizona VA Health Care System", "LocationStatus":"Recruiting", "LocationCity":"Tucson", "LocationState":"Arizona", "LocationZip":"85723", "LocationCountry":"United States", "LocationContactList":{ "LocationContact":[ { "LocationContactName":"Sergio Thal, M.D.", "LocationContactRole":"Contact", "LocationContactPhone":"520-792-1450", "LocationContactPhoneExt":"4624", "LocationContactEMail":"sergio.thal@va.gov" },{ "LocationContactName":"Elizabeth Juneman, M.D.", "LocationContactRole":"Contact", "LocationContactPhone":"520-792-1450", "LocationContactPhoneExt":"4624", "LocationContactEMail":"elizabeth.juneman@va.gov" },{ "LocationContactName":"Sergio Thal, M.D.", "LocationContactRole":"Principal Investigator" },{ "LocationContactName":"Elizabeth Juneman, M.D.", "LocationContactRole":"Sub-Investigator" },{ "LocationContactName":"Hoang Thai, M.D.", "LocationContactRole":"Sub-Investigator" } ] } },{ "LocationFacility":"Lexington VA Medical Center", "LocationStatus":"Recruiting", "LocationCity":"Lexington", "LocationState":"Kentucky", "LocationZip":"40502", "LocationCountry":"United States", "LocationContactList":{ "LocationContact":[ { "LocationContactName":"Samy Elayi, M.D.", "LocationContactRole":"Contact", "LocationContactPhone":"859-233-4511" },{ "LocationContactName":"Samy Elayi, M.D.", "LocationContactRole":"Principal Investigator" } ] } } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000006333", "ConditionMeshTerm":"Heart Failure" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000006331", "ConditionAncestorTerm":"Heart Diseases" },{ "ConditionAncestorId":"D000002318", "ConditionAncestorTerm":"Cardiovascular Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M8004", "ConditionBrowseLeafName":"Heart Failure", "ConditionBrowseLeafAsFound":"Heart Failure", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M10493", "ConditionBrowseLeafName":"Mitral Valve Insufficiency", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8002", "ConditionBrowseLeafName":"Heart Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC14", "ConditionBrowseBranchName":"Heart and Blood Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }