[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Magenta Medical Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":67},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100593045","elevate-high-risk-pci-pivotal-study-100593045",false,"NCT07001332","ELEVATE High-Risk PCI Pivotal Study","ELEVATE III","Inclusion Criteria:\n\n1. Non-emergent, percutaneous coronary intervention is planned on at least one stenotic lesion of a native coronary artery or bypass graft (de novo or restenosis).\n2. A heart team that includes an interventional cardiologist and cardiac surgeon has determined that HR- PCI is an appropriate therapeutic option.\n3. Participant signed the informed consent.\n\nExclusion Criteria:\n\n1. Cardiogenic shock or acutely decompensated pre-existing chronic heart failure.\n2. Prior stroke with any permanent, significant (mRS\\>2) neurological deficit, or stroke or TIA within 3 months prior to enrollment.\n3. Any condition or scheduled surgery that will require discontinuation of the antiplatelet and\u002For anticoagulation therapy within 90 days of the index procedure.\n4. Evidence of left ventricular thrombus.\n5. Aortic valve stenosis\u002Fcalcification (valve area ≤ 1.5 cm2).\n6. ≥ Moderate aortic valve regurgitation (≥ 2+ on a 4-grade scale by transthoracic echocardiography).\n7. Femoral access site incompatibility that precludes placement of either the Treatment or Control device.\n8. Patient on dialysis.\n9. Known or suspected coagulopathy OR abnormal coagulation parameters.\n10. Known allergy, sensitivity or intolerance to nickel.\n11. Infection of the proposed procedural access site; OR suspected systemic active infection, including any fever or known active COVID-19 infection.\n12. Allergy, sensitivity or intolerance to heparin, or contrast media, including known heparin-induced thrombocytopenia (HIT).\n13. Any non-cardiac condition with a life expectancy \\\u003C 12 months.\n14. Subject participation in another investigational drug or device trial (with the exception of post-market registries and observational studies, subject to Sponsor review and approval).\n15. Pregnancy or breast-feeding.\n16. Subject has other medical, social, or psychological problems that, in the opinion of the Investigator, compromise the participant's ability to provide written informed consent and\u002For to comply with study procedures.\n17. Subject belongs to a vulnerable population.","ALL","18 Years","88 Years",{"count":20,"type":21},290,"ESTIMATED","INTERVENTIONAL",[24],"NA","The ELEVATE III Pivotal Study is a prospective, multi-center, open-label, interventional, randomized, controlled study with an active control group. The study is intended to assess the safety and efficacy of the Elevate™ percutaneous Left Ventricular Assist Device System in patients referred to high-risk percutaneous coronary interventions (HR-PCI).",[27],"High-Risk Percutaneous Coronary Intervention (High-risk PCI)","RECRUITING","2026-04-24",{"date":31,"type":32},"2026-04-28","ACTUAL",{"date":34,"type":32},"2025-07-25",{"date":36,"type":21},"2027-09-16",{"name":38,"class":39},"Magenta Medical Ltd.","INDUSTRY",29,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100615539","magenta-elevate-clinical-feasibility-study-in-cardiogenic-shock-100615539","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.","40 Years","89 Years",{"count":51,"type":21},10,[24],"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.",[55,56,57],"Cardiogenic Shock","Heart Failure","Acute Myocardial Infarction (AMI)","2026-02-25",{"date":60,"type":32},"2026-02-27",{"date":62,"type":32},"2025-11-05",{"date":64,"type":21},"2026-10-30",{"name":38,"class":39},5,""]