[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638835":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":32,"locations":40,"responsibleParty":55,"collaborators":10,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":10,"enrollmentInfo":67,"targetDuration":10,"studyType":70,"phases":10,"briefSummary":71,"conditions":72,"keywords":76,"overallStatus":42,"whyStopped":10,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Medical University of Vienna","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Native heart recovery",null,"Patients supported with the Impella 5.5 device (J\\&J MedTech) achieving native heart recovery",[13],"Device: Micro-axial flow pump support",{"label":15,"type":10,"description":16,"interventionNames":17},"Heart replacement therapy (durable MCS or HTX)","Patients supported with the Impella 5.5 device (J\\&J MedTech) transitioning to heart replacement therapy (durable mechanical circulatory support or heart transplantation",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"All-cause mortality","Patients supported with the Impella 5.5 device (J\\&J MedTech) suffering from all-cause mortality during mechanical circulatory support.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"DEVICE","Micro-axial flow pump support","Temporary circulatory support using the Impella 5.5 micro-axial flow pump. The device is surgically placed (typically via the axillary artery) across the aortic valve into the left ventricle to provide active forward flow, unloading the left ventricle and maintaining systemic perfusion during cardiogenic shock. Management of the device includes the collection and analysis of continuous device-derived hemodynamic data and associated clinical parameters throughout the duration of support.",[19,15,9],[29],{"name":30,"affiliation":5,"role":31},"Thomas Schlöglhofer, PhD, MSc","PRINCIPAL_INVESTIGATOR",[33,37],{"name":30,"role":34,"phone":35,"phoneExt":10,"email":36},"CONTACT","+4314040027280","thomas.schloeglhofer@meduniwien.ac.at",{"name":38,"role":34,"phone":10,"phoneExt":35,"email":39},"Lukas Ruoff, MSc","lukas.ruoff@meduniwien.ac.at",[41],{"facility":5,"status":42,"city":43,"state":10,"zip":10,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Vienna","Austria","AT",{"type":47,"coordinates":48},"Point",[49,50],16.37208,48.20849,{"lat":50,"lon":49},[53,54],{"name":30,"role":34,"phone":35,"phoneExt":10,"email":36},{"name":38,"role":34,"phone":10,"phoneExt":35,"email":39},{"type":31,"investigatorFullName":30,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Technical Director Mechanical Circulatory Support Program","100638835","optimize-55---optimizing-impella-55-outcomes-through-advanced-data-science-100638835",false,"NCT07619144","OPTIMIZE 5.5 - Optimizing Impella 5.5 Outcomes Through Advanced Data Science","Clinical Outcomes and Adverse Events Associated With Microaxial Flow Pump Support: An Explorative Retrospective Study","OPTIMIZE","Inclusion Criteria:\n\n* Adult patients who were treated for cardiogenic shock and supported with an Impella 5.5 micro-axial flow pump\n* Only patients with available high-resolution pump data (downloaded from the clinical console) and ICU digital health record datasets\n\nExclusion Criteria:\n\n* Patients supported with an Impella 5.5 for indications other than cardiogenic shock (e.g., protected PCI or CABG)\n* Patients younger than 18 years\n* Patients with incomplete data, procedural records, or demographic information","ALL","18 Years",{"count":68,"type":69},100,"ESTIMATED","OBSERVATIONAL","The main goal of this observational, study is to develop a clinical decision support tool utilizing Impella 5.5 pump parameters to predict native heart recovery and prevent adverse events, by leveraging data science and real-world clinical data of cardiogenic shock patients.\n\nTherefore, secondary objectives are essential to consolidating a retrospective longitudinal analysis of Impella 5.5 pump data alongside ICU digital health record datasets to:\n\n1. Validate the Impella 5.5 placement signal by comparing it with ICU arterial line waveforms.\n2. Integrate pump data with ICU clinical data to identify patterns associated with therapy outcomes, including native heart recovery, heart replacement therapy, and mortality while on device support.\n3. Define clinical scenarios linked to hemolysis, HRAEs, and arrhythmias and develop predictive models to mitigate their occurrence.",[73,74,75],"Cardiogenic Shock","Mechanical Circulatory Support","Cardiogenic Shock Post Myocardial Infarction",[77,78,79,80,81],"cardiogenic shock","mechanical circulatory support","Impella 5.5","micro-axial flow pump","data science","2026-05-27",{"date":84,"type":85},"2026-06-01","ACTUAL",{"date":87,"type":85},"2026-05-08",{"date":89,"type":69},"2029-05-30",{"name":5,"class":6},1]