{
  "FullStudy":{
    "Rank":217843,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01516112",
          "OrgStudyIdInfo":{
            "OrgStudyId":"HMR-1.0-MEIR"
          },
          "Organization":{
            "OrgFullName":"Meir Hospital, Kfar Saba, Israel",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Meir Medical Center Home Monitoring Clinic Registry",
          "OfficialTitle":"Meir Medical Center Home Monitoring Clinic Registry"
        },
        "StatusModule":{
          "StatusVerifiedDate":"July 2011",
          "OverallStatus":"Unknown status",
          "LastKnownStatus":"Not yet recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"February 2012"
          },
          "StudyFirstSubmitDate":"January 19, 2012",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 24, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 19, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 24, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"chetboun israel",
            "ResponsiblePartyInvestigatorTitle":"Dr. Israel Chetboun",
            "ResponsiblePartyInvestigatorAffiliation":"Meir Hospital, Kfar Saba, Israel"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Meir Hospital, Kfar Saba, Israel",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of the registry is to assess workload of a Home Monitoring based follow up for Biotronik ICD and CRTD patients."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Patients Implanted With an ICD or CRTD."
            ]
          },
          "KeywordList":{
            "Keyword":[
              "ICD, home monitoring, cardiomessenger, implant"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Case-Only"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"20",
            "EnrollmentType":"Anticipated"
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nApproved indication for ICD or CRTD\nImplanted with or replaced with a Biotronik Lumax device\nPatient willing and able to sign consent form\nWilling and able to attend clinic visits and follow up schedule\nTransmission of more than 80% at 3-month follow up\nPatient older than 18 years\n\nExclusion Criteria:\n\nno indication for ICD or CRTD implant\nLife expectancy shorter than 12 months\nPregnancy\nParticipation in other clinical studies",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"Patients implanted with an ICD or CRTD.",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "CentralContactList":{
            "CentralContact":[
              {
                "CentralContactName":"Israel Chetboun, M.D",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"+972-577482449",
                "CentralContactEMail":"shetboun.israel@clalit.org.il"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Meir MC",
                "LocationCity":"Kefar Saba",
                "LocationCountry":"Israel",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"Israel Chetboun, M.D.",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"+972-575482449",
                      "LocationContactEMail":"shetboun.israel@clalit.org.il"
                    },{
                      "LocationContactName":"Israel Chetboun, M.D",
                      "LocationContactRole":"Principal Investigator"
                    }
                  ]
                }
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        }
      }
    }
  }
}