[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575997":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":21,"studyPopulation":22,"armGroups":23,"interventions":32,"overallOfficials":17,"centralContacts":38,"locations":44,"responsibleParty":61,"collaborators":17,"id":63,"slug":17,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":17,"eligibilityCriteria":67,"healthyVolunteers":64,"sex":68,"minAge":69,"maxAge":17,"enrollmentInfo":70,"targetDuration":17,"studyType":73,"phases":17,"briefSummary":74,"conditions":75,"keywords":17,"overallStatus":47,"whyStopped":17,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Abbott Medical Devices","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"HF Hospitalization Rate.","Compare HF hospitalization rate between the treatment and control groups.","2 years",[14],{"measure":15,"description":16,"timeFrame":12},"Two-Year Survival","Compare survival between the treatment and control groups.",null,{"allocation":17,"interventionModel":17,"interventionModelDescription":17,"primaryPurpose":17,"observationalModel":19,"timePerspective":20,"maskingInfo":17},"COHORT","PROSPECTIVE","The CardioMEMS CED Study will assess 2-year HF hospitalization rates and survival for all-cause mortality in heart failure subjects managed with the CardioMEMS HF system, as compared to a contemporaneous control of HF subjects managed without PA pressure-guidance.","The study population will include Heart Failure patients in the United States implanted with the CardioMEMS PA pressure sensor and HF patients being managed without PA pressure-monitoring.",[24,29],{"label":25,"type":17,"description":26,"interventionNames":27},"Treatment Group","Heart failure patients implanted with the CardioMEMS PA pressure sensor.",[28],"Device: CardioMEMS HF System",{"label":30,"type":17,"description":31,"interventionNames":17},"Control Group","Heart failure patients being managed without PA pressure-monitoring.",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":17},"DEVICE","CardioMEMS HF System","PA Pressure Sensor",[25],[39],{"name":40,"role":41,"phone":42,"phoneExt":17,"email":43},"Nessa Johnson","CONTACT","612-283-3865","nessa.johnson@abbott.com",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Abbott","RECRUITING","Pleasanton","California","94588","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-121.87468,37.66243,{"lat":57,"lon":56},[60],{"name":40,"role":41,"phone":42,"phoneExt":17,"email":43},{"type":62,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100575997",false,"NCT06779552","CardioMEMS HF System Coverage With Evidence Development Study","Inclusion Criteria:\n\n1. Subject implanted with a CardioMEMS pressure sensor (treatment arm only)\n2. Subject \\>=18 years of age at time of implant\n3. Subject has a history of acute decompensated HF or HF-related congestion defined by at least one of the following qualifying event types: HF hospitalization, elevated BNP\u002FNT-proBNP\n\nExclusion Criteria:\n\n1. Subject has history of heart transplant or durable mechanical circulatory device\n2. Subject hospitalized with cardiogenic shock or sepsis\n3. Subject received prior PA pressure sensor implant (control arm only)","ALL","18 Years",{"count":71,"type":72},1000,"ESTIMATED","OBSERVATIONAL","The purpose of the CardioMEMS CED Study is to determine if pulmonary artery (PA) pressure-guided heart failure management using the CardioMEMS™ HF System improves long-term health outcomes in heart failure (HF) patients in the real-world setting.",[76],"Heart Failure","2026-03-30",{"date":79,"type":80},"2026-04-03","ACTUAL",{"date":82,"type":80},"2025-02-07",{"date":84,"type":72},"2032-03",{"name":5,"class":6},1]