{
  "FullStudy":{
    "Rank":217565,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01519739",
          "OrgStudyIdInfo":{
            "OrgStudyId":"CR-11-043-EU-MG"
          },
          "Organization":{
            "OrgFullName":"Abbott Medical Devices",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Clinical Evaluation of Mediguide System in Cardiac Resynchronization Therapy (CRT) Implants",
          "OfficialTitle":"Clinical Evaluation of Mediguide System in CRT Implants"
        },
        "StatusModule":{
          "StatusVerifiedDate":"October 2019",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"May 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"November 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 18, 2012",
          "StudyFirstSubmitQCDate":"January 26, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 27, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"October 28, 2019",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"October 30, 2019",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Abbott Medical Devices",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No",
          "IsFDARegulatedDrug":"No",
          "IsFDARegulatedDevice":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to evaluate the safety and performance of the MediGuide™ system during CRT implants."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Heart Failure"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"15",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"MediGuide Arm",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: MediGuide™"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Device",
                "InterventionName":"MediGuide™",
                "InterventionDescription":"MediGuide™ system will be used to guide CRT implants",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "MediGuide Arm"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"The performance of the MediGuide™ system during CRT implant",
                "PrimaryOutcomeDescription":"Performance will be assessed in terms occurence of adverse events, easy of use and potential benefits.",
                "PrimaryOutcomeTimeFrame":"1 month post CRT implant"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nMeet clinical indication for implantation of an SJM CRT system according to the current European Society of Cardiology (ESC) Guidelines for cardiac and resynchronization therapy\nReceiving a new implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement\nAbility to provide informed consent for study participation and are willing and able to comply with the prescribed follow-up tests and schedule of evaluations\n\nExclusion Criteria:\n\nCurrently participating in any other clinical study\nHave prosthetic valves\nAre pregnant or planning pregnancy in the next 1 month\nAre less than 18 years of age\nHave ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Gerhard Hindricks, MD",
                "OverallOfficialAffiliation":"Herzzentrum Leipzig GmbH",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"24002003",
                "ReferenceType":"derived",
                "ReferenceCitation":"Richter S, Döring M, Gaspar T, John S, Rolf S, Sommer P, Hindricks G, Piorkowski C. Cardiac resynchronization therapy device implantation using a new sensor-based navigation system: results from the first human use study. Circ Arrhythm Electrophysiol. 2013 Oct;6(5):917-23. doi: 10.1161/CIRCEP.113.000066. Epub 2013 Sep 3."
              }
            ]
          },
          "SeeAlsoLinkList":{
            "SeeAlsoLink":[
              {
                "SeeAlsoLinkLabel":"Published paper (Circ Arrhythm Electrophysiol, 2013) for a feasibility study",
                "SeeAlsoLinkURL":"http://www.ncbi.nlm.nih.gov/pubmed/24002003"
              }
            ]
          }
        }
      },
      "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":"M8002",
                "ConditionBrowseLeafName":"Heart Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC14",
                "ConditionBrowseBranchName":"Heart and Blood Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}