[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Abiomed Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":135},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,40,61,96,115],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100590228","assessment-of-support-with-impella-best-practices-in-acute-myocardial-infarction-complicated-by-cardiogenic-shock-100590228",false,"NCT06964685","Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock","Observational Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock","OASIS-AMICS","Inclusion Criteria:\n\n* Acute myocardial infarction (AMI) of \\\u003C36 hours duration from symptom onset to cath lab arrival, confirmed by:\n\n  * ECG and\u002For biomarker evidence of ST-segment elevation myocardial infarction (STEMI), STEMI equivalents, or new or presumed new left bundle branch block or\n  * ECG and\u002For biomarker evidence of non-ST-segment elevation myocardial infarction (NSTEMI) and angiographic evidence of one or more culprit vessels\n* Cardiogenic shock confirmed by at least two of the following:\n\n  * Tissue hypoperfusion, manifested by an arterial or venous blood lactate level ≥2.5 mmol\u002FL or SvO2 \\\u003C55% in the presence of a PaO2 \\> 90mmHg\n  * Systolic blood pressure \\\u003C100 mmHg or need for vasoactive agents to maintain systolic blood pressure ≥100 mmHg\n  * Hemodynamic criteria represented by a cardiac index of \\\u003C2.2 L\u002Fmin\u002Fm\\^2 or a cardiac power output ≤0.6 W\n* Cardiogenic shock that develops under one of the following conditions:\n\n  * prior to primary PCI, with \\\u003C24 hours from the onset of shock to cath lab arrival, or\n  * \\\u003C12 hours after initiating primary PCI\n* Patient was supported with Impella CP as the initial MCS device for cardiogenic shock\n* Age ≥18 years\n* Europe only: Subject or legally designated representative (LDR) or Independent Physician has provided written informed consent for participation in the observational study\n\nExclusion Criteria:\n\n* Any contraindication listed in the Impella CP IFU if known to be present (i.e. mural thrombus in the left ventricle; presence of a mechanical aortic valve or heart constrictive device; aortic valve stenosis\u002Fcalcification (equivalent to an orifice area of 0.6 cm2 or less); moderate to severe aortic insufficiency (echocardiographic assessment graded as ≥ +2); severe arterial disease precluding placement of the Impella system; presence of an atrial or ventricular septal defect (including post-infarct VSD); significant right heart failure; left ventricular rupture; cardiac tamponade; combined cardiorespiratory failure).\n* Shock principally due to a cause other than LV failure, including:\n\n  * RV infarction, hypovolemia, anaphylaxis, hemorrhage, sepsis, myocarditis, pulmonary embolism, pneumothorax, or high cardiac output shock\n  * Severe arrhythmias as the primary cause of low cardiac output, including acute bradyarrhythmias, tachyarrhythmias, or advanced heart block\n  * Known mechanical complications of AMI that may cause cardiogenic shock such as free wall rupture, ventricular septal defect or papillary muscle rupture with acute mitral regurgitation\n  * Procedural complication of the PCI that results in coronary perforation\n* Other mechanical circulatory support already in place for present indication, including intra-aortic balloon counter-pulsation or patients with Impella CP placement prior to transfer to the cath lab at the tertiary facility\n* Acute or chronic aortic dissection\n* Prior PCI at another institution for the present infarction\n* Thrombolytic therapy for the present infarction\n* Not obeying verbal commands after preadmission or in-hospital cardiac arrest, indicative of possible anoxic brain injury NOTE:\n\n  * Non-intubated subjects: A positive and appropriate response to commands must be repeatable on at least two (2) instances to rule out reflex response to voice\n  * Intubated subjects are excluded if: They were not following verbal commands immediately prior to intubation, or They were not clearly following verbal commands after intubation within 6 hours post-PCI\n* Infective endocarditis\n* Other severe, concomitant disease with limited life expectancy \\\u003C1 year (other than cardiogenic shock)\n* Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device that has not reached the timing of its primary endpoint","ALL","18 Years",{"count":20,"type":21},350,"ESTIMATED","1 Year","OBSERVATIONAL","The observational study titled \"Observational Assessment of Support with Impella Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock (OASIS-AMICS)\" aims to evaluate the safety outcomes of patients with acute myocardial infarction complicated by cardiogenic shock (AMICS) who receive Impella CP during percutaneous coronary intervention (PCI) and who are managed with Impella best practices while receiving guideline-directed standard of care. This prospective, multicenter study will enroll up to 350 hemodynamically unstable patients with cardiogenic shock of less than 12 hours duration and acute myocardial infarction (AMI) of less than 24 hours duration. Cardiogenic shock will be confirmed by tissue hypoperfusion (lactate ≥ 2.5mmol\u002FL and\u002For SvO2 \\\u003C55% with a normal PaO2) and systolic blood pressure \\\u003C100 mmHg and\u002For need for vasopressor therapy (dopamine\u002Fnorepinepherine or epinephrine). Patients will be assessed for various safety endpoints, including a composite safety endpoint involving major bleeding, acute limb ischemia, and acute kidney injury. Secondary endpoints will evaluate all-cause mortality, major adverse cardiovascular and cerebrovascular events (MACCE), and hospitalizations through 1-year post-Impella implant. All patients presenting with AMICS at study sites will be screened for inclusion in the study after hospital discharge (or after death, if prior to hospital discharge). IRB approved consent waiver will be used to collect data from electronic health records from; Impella placement to discharge and post-discharge at 30 days post-Impella implant, 6 months post-Impella implant, and 1 year post-Impella implant.",[26],"AMI Cardiogenic Shock","RECRUITING","2026-06-26",{"date":30,"type":31},"2026-06-30","ACTUAL",{"date":33,"type":31},"2025-07-10",{"date":35,"type":21},"2028-10-30",{"name":37,"class":38},"Abiomed Inc.","INDUSTRY",17,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":47,"targetDuration":49,"studyType":23,"phases":4,"briefSummary":45,"conditions":50,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":60},"100539762","abiomed-impella-rt-daq---observational-study-100539762","NCT06308055","Abiomed Impella RT-DAQ - Observational Study","Abiomed IMPELLA-RT-DAQ - Impella Real Time Data AcQuisition","Inclusion Criteria:\n\n1. Ongoing or planned intensive care management with Impella support\n2. Presence or planned placement of a cardiac output measurement\n\n   1. Preferentially pulmonary catheter (including cardiac output (CO) preferred as continuous measurement)\n   2. Other means of discontinuous CO measurement incl. echocardiography, other thermodilution methods\n\nExclusion Criteria:\n\n1. Age \\\u003C 18 years\n2. Pregnancy\n3. Anticipated support duration \\\u003C24 h",{"count":48,"type":21},125,"2 Days",[51],"Cardiogenic Shock","2026-06-16",{"date":54,"type":31},"2026-06-17",{"date":56,"type":31},"2024-10-04",{"date":58,"type":21},"2027-12-31",{"name":37,"class":38},4,{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":69,"enrollmentInfo":70,"targetDuration":4,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},"100590291","initiation-and-titration-of-guideline-directed-medical-therapy-in-heart-failure-cardiogenic-shock-with-impella-55-for-cardiac-recovery-100590291","NCT06965504","INitiation and Titration of Guideline Directed Medical TheRApy in HearT Failure Cardiogenic Shock With ImpElla 5.5 for Cardiac Recovery","Initiation and Titration of Guideline Directed Medical Therapy in Heart Failure Cardiogenic Shock With Impella 5.5 for Cardiac Recovery: INTeGRATE","INTeGRATE","Inclusion Criteria:\n\n1. Age ≥ 18 and \\\u003C 80 years\n2. Subject has signed the Informed Consent Form. If the subject has been enrolled via an LAR, the subject must provide assent, the assent will be documented.\n3. LVEF ≤ 40%\n4. Subject is presenting with decompensated heart failure and meets at least one (1) of the following cardiogenic shock criteria:\n\n   1. Sustained episode of systolic blood pressure ≤ 90 mmHg for at least 30 minutes or need for vasoactive agents to maintain such blood pressure.\n   2. Cardiac index (CI) \\\u003C 2.2 L\u002Fmin\u002Fm2 determined to be secondary to cardiac dysfunction, in the absence of hypovolemia.\n   3. Require support with an intra-aortic balloon pump (IABP)\n   4. Serum lactate \\>2 mmol\u002FL\n5. Subject has inadequate heart failure GDMT based on the most recent outpatient prescription prior to index admission, defined as:\n\n   1. On 2 or less of the 4-Pillar HF Drug Classes (BB, MRA, SGLT2i, and RASi)\n   2. If on BB and RASi, at least one of the two medications is \\\u003C 50% of the maximal target dose.\n\nExclusion Criteria:\n\n1. Underlying unmodifiable conditions that limit initiation of GDMT prior to enrollment, including but not limited to:\n\n   1. Drug allergies or hypersensitivities\\* to HF GDMT medications, unless alternative can be identified.\n\n      \\*Drug allergy\u002Fhypersensitivity is an immune-mediated reaction to a medication. Adverse reactions must be a result of immune or inflammatory cell stimulations by the mеԁiсаtion.\n   2. Known bilateral renal artery stenosis\n   3. Type 1 diabetes\n   4. 2o or 3o AV block, unless pacemaker is in place\n   5. Angioedema, hereditary or idiopathic\n   6. Pregnancy, known or confirmed by a pregnancy test if of childbearing potential\n2. ST-segment elevation or acute coronary syndrome (ACS) prior to enrollment\n3. Septic shock, shock from non-cardiac origins, or mixed shock\n4. SCAI Stage E cardiogenic shock per study definition (Appendix C) prior to enrollment\n5. In cardiac arrest prior to enrollment\n6. Intra-aortic balloon pump (IABP) use \\>24 hours from the onset of cardiogenic shock if placed at the enrolling site or \\>48 hours if transferred on IABP prior to enrollment\n7. On mechanical circulatory support other than IABP (i.e. ECMO, Impella CP, etc) or on mechanical ventilation for non-procedural reasons prior to enrollment\n8. Revascularization or cardiac surgery within 30-days of the index hospitalization date or decision to undergo revascularization or cardiac surgery made prior to enrollment\n9. Infiltrative\u002Frestrictive cardiomyopathy (sarcoidosis and amyloidosis), hypertrophic cardiomyopathy, constrictive pericarditis, pericardiac tamponade, or fulminant myocarditis (giant cell or immune checkpoint inhibitor)\n10. Complex adult congenital heart disease\n11. Primary severe valvular disease\n12. Predominant RV dysfunction per Investigator's discretion\n13. History of heart transplant or listed for heart transplant or planned for heart transplantation prior to enrollment.\n14. Planned to be implanted with a permanent VAD within 180-days of the index hospitalization date.\n15. Continuous outpatient inotropic support prior to the index hospitalization date.\n16. Planned to pursue palliative care or hospice, or life expectancy of less than 1 year due to non-cardiac illness at the time of index hospitalization date.\n17. Currently on dialysis, or has pre-existing end-stage chronic kidney disease (stage 4 and above), or has nephropathy of hereditary, infectious, or autoimmune origin.\n18. Pre-existing liver disease including liver cirrhosis, alcoholic hepatitis, metabolic dysfunction associated steatohepatitis (MASH), or genetic liver disease.\n19. Pre-existing pulmonary disease with oxygen dependency.\n20. History of stroke or intracranial hemorrhage ≤ 90 days prior to the index hospitalization date, or a history of cerebrovascular disease with significant (\\> 80%) uncorrected carotid stenosis, or any permanent neurological deficit with modified Rankin Scale (mRS) \\>2.\n21. Any contraindication that precludes placing an Impella 5.5®, including but not limited to:\n\n    1. Aortic valve stenosis\u002Fcalcification with orifice area ≤ 0.6cm2 or aortic insufficiency of any grade greater than mild on pre-procedure echocardiography.\n    2. Presence of mechanical aortic valve or heart constrictive device\n    3. Thrombus in the left atrium or ventricle\n    4. Infection of the planned procedural access site or suspected systemic active infection.\n    5. Severe arterial disease precluding placement of Impella\n    6. Presence of Atrial or Ventricular Septal Defect\n    7. Left ventricular rupture\n    8. Cardiac tamponade\n    9. Combined cardiorespiratory failure\n22. Intolerance to anticoagulant or antiplatelet therapies, or will refuse blood transfusions.\n23. Subject has other medical, social or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent (or assent if LAR) and\u002For to comply with study procedures.\n24. Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device.\n25. Subject belongs to a vulnerable population, such as prisoners, pregnant women, handicapped, mentally disabled persons, or economically or educationally disadvantaged persons per 21CFR56.111(a)(3) and 111(b).","80 Years",{"count":71,"type":21},250,"INTERVENTIONAL",[74],"NA","The study will evaluate the impact of a combined device-drug strategy with Impella 5.5 with best practices and optimized GDMT on heart recovery outcomes in patients with decompensated heart failure and cardiogenic shock.",[77,51,78],"Heart Failure","Reduced Ejection Fraction Heart Failure",[80,81,78,82,83,84,85],"Impella 5.5","Heart Failure Cardiogenic Shock","Mechanical Circulatory Support","Cardiovascular Disease","Heart Disease","Guideline Directed Medical Therapy","NOT_YET_RECRUITING","2026-04-20",{"date":89,"type":31},"2026-04-23",{"date":91,"type":21},"2026-04-01",{"date":93,"type":21},"2029-06-01",{"name":37,"class":38},7,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":95},"100574895","impella-pump-return-study-to-analyze-deposits-and-biomaterial-in-used-pumps-100574895","NCT06765226","Impella Pump Return Study to Analyze Deposits and Biomaterial in Used Pumps","Abiomed Impella Pump Return Registry - Observational Study","Inclusion Criteria:\n\n* Patients with Impella 5.5 therapy and duration of support for ≥ 25 days OR Patients with Impella CP therapy and duration of support for \\> 4 days\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years",{"count":104,"type":21},200,"Analysis of cell and protein deposits on the Impella Heart Pump.",[77],"2025-09-30",{"date":109,"type":31},"2025-10-03",{"date":111,"type":31},"2025-09-21",{"date":113,"type":21},"2031-01-31",{"name":37,"class":38},{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":122,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},"100565089","impella-rp-flex-with-smart-assist-100565089","NCT06637644","Impella RP Flex with Smart Assist","Impella RP Flex Registry","Inclusion Criteria:\n\n* Subjects who received mechanical circulatory support (MCS) with an Impella RP Flex will be considered eligible for the registry.\n\nExclusion Criteria:\n\n* None",{"count":104,"type":21},"To capture observational data of the Abiomed Impella RP Flex in a real-world setting.",[125],"Right Ventricular (RV) Dysfunction","2024-10-09",{"date":128,"type":31},"2024-10-15",{"date":130,"type":31},"2024-05-29",{"date":132,"type":21},"2026-06-01",{"name":37,"class":38},31,""]