{
  "FullStudy":{
    "Rank":218127,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01512381",
          "OrgStudyIdInfo":{
            "OrgStudyId":"zubarev-vista-17-12"
          },
          "Organization":{
            "OrgFullName":"Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Atrioventricular Node Ablation in Patients With Atrial Fibrillation and Moderate Chronic Heart Failure",
          "OfficialTitle":"Variant of Stimulation in Atrioventricular Node Ablation (VISTA) in Patients With Atrial Fibrillation and Moderate Chronic Heart Failure",
          "Acronym":"VISTA"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2017",
          "OverallStatus":"Terminated",
          "WhyStopped":"Absence of patients for recruitment",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"December 2010",
            "StartDateType":"Actual"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"September 2017",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2017",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 12, 2012",
          "StudyFirstSubmitQCDate":"January 14, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"June 5, 2018",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"June 6, 2018",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to determine whether cardiac resynchronization therapy (CRT) is superior to interventricular right ventricle (RV) septal pacing in respect of reverse remodeling (LV ESD) and morbidity in patients with less preserved (less than 45%) ejection fraction (EF), persistent/permanent atrial fibrillation (AF) who successfully received atrioventricular (AV) junction ablation ablation (100% pacemaker dependency)"
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Heart Failure"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "heart failure",
              "CRT",
              "atrial fibrillation",
              "AV junction ablation"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 4"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"11",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"CRT",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: Implantation of CRT device"
                  ]
                }
              },{
                "ArmGroupLabel":"pacemaker",
                "ArmGroupType":"Active Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: Implantation of conventional VVI(R) pacemaker"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Device",
                "InterventionName":"Implantation of CRT device",
                "InterventionDescription":"RV lead of CRT system is implanted into the middle part of interventricular septum",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "CRT"
                  ]
                }
              },{
                "InterventionType":"Device",
                "InterventionName":"Implantation of conventional VVI(R) pacemaker",
                "InterventionDescription":"RV lead is implanted into the middle part of interventricular septum",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "pacemaker"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Left Ventricle End-Systolic Volume (LV ESV)",
                "PrimaryOutcomeTimeFrame":"12 months"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Rate of cardiovascular events (hospitalization for worsening heart failure)",
                "SecondaryOutcomeTimeFrame":"12 month"
              },{
                "SecondaryOutcomeMeasure":"Changes in Quality of Life (measured by Minnesota Living with Heart Failure Questionnaire)",
                "SecondaryOutcomeTimeFrame":"12 months"
              },{
                "SecondaryOutcomeMeasure":"Changes in NYHA functional class measured by peak V O2 oxygen consumption and distance of 6-minute walk test",
                "SecondaryOutcomeTimeFrame":"12 months"
              },{
                "SecondaryOutcomeMeasure":"Echocardiographic indexes of LV remodeling",
                "SecondaryOutcomeTimeFrame":"12 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAge of 18-75 years\nCHF II-III NYHA\nPersistent/permanent AF requiring AV node ablation\nLVEF < 45%\nSigned informed consent\nAble to complete all testing required by the clinical protocol\n\nExclusion Criteria:\n\nMyocardial infarction or stroke less than 3 months prior to randomization\nPatients who require revascularization, radiofrequency ablation of pulmonary veins and substrate of AF\nThe congenital and acquired heart diseases, LV aneurysm, which requires a surgical correction\nActive inflammatory and autoimmune diseases of a myocardium\nThe thyrotoxicosis\nThe diseases that limit life expectancy (cancer, tuberculosis, etc.)\nContraindications to anticoagulants administration at CHADS2> 2\nUncompliant patients",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"75 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Almazov Federal Heart, Blood and Endocrinology Centre",
                "LocationCity":"Saint-Petersburg",
                "LocationZip":"197341",
                "LocationCountry":"Russian Federation"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000006333",
                "ConditionMeshTerm":"Heart Failure"
              },{
                "ConditionMeshId":"D000001281",
                "ConditionMeshTerm":"Atrial Fibrillation"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000006331",
                "ConditionAncestorTerm":"Heart Diseases"
              },{
                "ConditionAncestorId":"D000002318",
                "ConditionAncestorTerm":"Cardiovascular Diseases"
              },{
                "ConditionAncestorId":"D000001145",
                "ConditionAncestorTerm":"Arrhythmias, Cardiac"
              },{
                "ConditionAncestorId":"D000010335",
                "ConditionAncestorTerm":"Pathologic Processes"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M3167",
                "ConditionBrowseLeafName":"Atrial Fibrillation",
                "ConditionBrowseLeafAsFound":"Atrial Fibrillation",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M8004",
                "ConditionBrowseLeafName":"Heart Failure",
                "ConditionBrowseLeafAsFound":"Heart Failure",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M8002",
                "ConditionBrowseLeafName":"Heart Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3034",
                "ConditionBrowseLeafName":"Arrhythmias, Cardiac",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC14",
                "ConditionBrowseBranchName":"Heart and Blood Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}