[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615539":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":91,"collaborators":20,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":20,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":20,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":20,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Magenta Medical Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Cardiogenic shock","EXPERIMENTAL","Acute myocardial infarction or acutely decompensated heart failure and cardiogenic shock patients",[13],"Device: Elevate™ System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Elevate™ System","The Elevate™ percutaneous Left Ventricular Assist Device System",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Yelena Lalazar","Magenta Medical","STUDY_DIRECTOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Yelena Lalazar Sr. Director Clinical Affairs","CONTACT","+972.50.6829528","yelenal@magentamed.com",[33,48,56,69,80],{"facility":34,"status":35,"city":36,"state":20,"zip":20,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Israeli-Georgian Medical Research Clinic Helsicore","RECRUITING","Tbilisi","Georgia","GE",{"type":40,"coordinates":41},"Point",[42,43],44.83412,41.69143,{"lat":43,"lon":42},[46],{"name":47,"role":29,"phone":20,"phoneExt":20,"email":20},"Irakli Gogorishvili, MD",{"facility":49,"status":35,"city":36,"state":20,"zip":20,"country":37,"countryCode":38,"cosmosGeoPoint":50,"geoPoint":52,"contacts":53},"Tbilisi Heart Center",{"type":40,"coordinates":51},[42,43],{"lat":43,"lon":42},[54],{"name":55,"role":29,"phone":20,"phoneExt":20,"email":20},"Archil Chukhrukidze, MD",{"facility":57,"status":35,"city":58,"state":20,"zip":20,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Shamir Medical Center","Be’er Ya‘aqov","Israel","IL",{"type":40,"coordinates":62},[63,64],34.83749,31.93864,{"lat":64,"lon":63},[67],{"name":68,"role":29,"phone":20,"phoneExt":20,"email":20},"Eran Kalmanovich, MD",{"facility":70,"status":35,"city":71,"state":20,"zip":20,"country":59,"countryCode":60,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Rambam Medical Center","Haifa",{"type":40,"coordinates":73},[74,75],34.99928,32.81303,{"lat":75,"lon":74},[78],{"name":79,"role":29,"phone":20,"phoneExt":20,"email":20},"Roni Abbo, MD",{"facility":81,"status":35,"city":82,"state":20,"zip":20,"country":59,"countryCode":60,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Tel-Aviv Sourasky Medical Center","Tel Aviv",{"type":40,"coordinates":84},[85,86],34.78057,32.08088,{"lat":86,"lon":85},[89],{"name":90,"role":29,"phone":20,"phoneExt":20,"email":20},"Yishay Szekely, MD",{"type":92,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100615539","magenta-elevate-clinical-feasibility-study-in-cardiogenic-shock-100615539",false,"NCT07293923","Magenta Elevate™ Clinical Feasibility Study in Cardiogenic Shock","Clinical Feasibility Study of the Magenta Elevate™ Percutaneous Left Ventricular Assist Device (pLVAD) System in Patients With Cardiogenic Shock","Inclusion Criteria:\n\n* Cardiogenic shock of less than 24 hours duration.\n* Left ventricular ejection fraction \\\u003C 45% and \\> 15%, as determined by echocardiography on the day of inclusion.\n* No more than mild right ventricular dysfunction, as determined by echocardiography on the day of inclusion.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Other causes of shock: hypovolemia, sepsis (any active systemic infection including acute myocarditis), pulmonary embolism or anaphylaxis.\n* Patient with oxygen saturation \\\u003C 90% (pulse oximeter\u002Farterial) at the planned time of device placement (uncorrected by oxygen supplementation or intubation).\n* Sustained VT (at the time of the enrollment).\n* Significant right heart failure\u002Fright ventricular dysfunction.\n* Awake patient who is unable to remain in a stable recumbent position due to restlessness or lack of cooperation for other reasons.\n* Hypertrophic obstructive cardiomyopathy.\n* Left ventricular thrombus.\n* Subjects with a placed IABP.\n* Mitral and\u002For aortic valve prothesis, or more than mild native mitral or aortic valve stenosis.\n* Aortic valve insufficiency ≥ 2+ (on a 4-grade scale).\n* Mechanical complication of myocardial infarction (e.g., ventricular septal rupture, papillary muscle rupture) or evidence of uncorrected Ventricular Septal Defect or Atrial Septal Defect (VSD\u002FASD).\n* Brain damage (e.g., anoxic) or suspected brain damage.\n* Stroke or transient ischemic attack within the past 3 months.\n* Uncorrectable abnormal coagulation parameters (defined as platelet count \\\u003C 100,000 or INR \\> 2.0 or fibrinogen \\\u003C 1.5 g\u002FL) or active uncontrolled bleeding.\n* Allergy, sensitivity or intolerance to heparin, aspirin, Adenosine Diphosphate (ADP) receptor blockers, or contrast media, including known heparin-induced thrombocytopenia.\n* Known allergy, sensitivity or intolerance to nickel.\n* Known or suspected severe lung disease.\n* Evidence of any vascular disease that would preclude placement of the device (e.g., severely calcified and stenosed ilio-femoral vessels).\n* Aortic pathology, such as aortic aneurysms, extreme tortuosity, or calcifications that could pose an undue additional risk to the placement of a pLVAD device.\n* Any known or suspected disorder causing fragility of blood cells or hemolysis.\n* Subject participation in another investigational drug or device trial (post-market registries may be approved by Magenta Medical).\n* Life expectancy \\\u003C 1 year due to comorbidities.","ALL","40 Years","89 Years",{"count":104,"type":105},10,"ESTIMATED","INTERVENTIONAL",[108],"NA","The Elevate™ CS Clinical Feasibility Study is designed to evaluate the initial safety, effectiveness, and device performance of the Magenta Elevate™ System in patients with cardiogenic shock due to isolated or predominant left ventricular failure.",[111,112,113],"Cardiogenic Shock","Heart Failure","Acute Myocardial Infarction (AMI)","2026-02-25",{"date":116,"type":117},"2026-02-27","ACTUAL",{"date":119,"type":117},"2025-11-05",{"date":121,"type":105},"2026-10-30",{"name":5,"class":6},5]