[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mechanical-circulatory-support\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mechanical-circulatory-support":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,53,86,117,143,172,202,230,259],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100172884","product-surveillance-registry-100172884",false,"NCT01524276","Product Surveillance Registry","Medtronic Product Surveillance Registry","PSR","Inclusion Criteria:\n\n* Patient or legally authorized representative provides written authorization and\u002For consent per institution and geographical requirements\n* Patient has or is intended to receive or be treated with an eligible Medtronic product\n* Patient within enrollment window relative to therapy initiation or meets criteria for retrospective enrollment\n\nExclusion Criteria:\n\n* Patient who is, or will be, inaccessible for follow-up\n* Patient with exclusion criteria required by local law\n* Patient is currently enrolled in or plans to enroll in any concurrent drug and\u002For device study that may confound results","ALL",{"count":19,"type":20},100000,"ESTIMATED","OBSERVATIONAL","The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.",[24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39],"Cardiac Rhythm Disorders","Urological Disorders","Neurological Disorders","Cardiovascular Disorders","Digestive Disorders","Intracranial Aneurysm","Mechanical Circulatory Support","Respiratory Therapy","Aortic, Peripheral Vascular and Venous Disorders","Minimally Invasive Surgical Procedures","Diagnostic Techniques and Procedures","Surgical Procedures, Operative","Renal Insufficiency","Neurovascular","Coronary Artery Disease","Ear, Nose and Throat Disorder","RECRUITING","2026-06-15",{"date":43,"type":44},"2026-06-17","ACTUAL",{"date":46,"type":4},"2012-01",{"date":48,"type":20},"2040-01",{"name":50,"class":51},"Medtronic","INDUSTRY",395,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100615756","pivotal-study-of-the-supira-system-in-patients-undergoing-high-risk-percutaneous-coronary-intervention-hrpci-100615756","NCT07296744","Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)","Pivotal Randomized Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)","SUPPORT II","Inclusion Criteria:\n\n* Hemodynamically stable and will undergo elective or urgent (not emergent) HRPCI, where hemodynamic support is deemed necessary, as determined by the institutional Heart Team\n* Informed consent granted by the subject or legally authorized representative\n\nExclusion Criteria:\n\n* Cardiogenic shock or acutely decompensated pre-existing chronic heart failure\n* Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit\n* Left ventricular thrombus\n* Aortic and iliofemoral anatomical conditions that preclude safe delivery and placement of the investigational device or the comparator device\n* Ongoing renal replacement therapy with dialysis\n* Presence of decompensated liver disease; severe liver dysfunction\n* Infection of the proposed procedural access site or active infection\n* Known hypersensitivity to intravenous contrast agents that cannot be adequately pre-medicated or known hypersensitivity to heparin, aspirin, adenosine diphosphate (ADP) receptor inhibitors, or nitinol\n* Any condition, coagulopathy, planned procedure or contraindication that requires discontinuation of antiplatelet and\u002For anticoagulant therapy within 90 days of the index procedure\n* Breastfeeding or pregnant or planning to become pregnant within 90 days of the HRPCI procedure\n* Currently participating in active follow-up phase of another clinical study of an investigational drug or device or planning to enroll in such a study within 90 days of the HRPCI procedure\n* Other medical, social, or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to provide written informed consent and\u002For to comply with study procedures\n* Considered to be part of a vulnerable population per the investigator's assessment","18 Years","90 Years",{"count":64,"type":20},358,"INTERVENTIONAL",[67],"NA","The objective of this study is to assess the safety and efficacy of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI. Eligible patients will be randomized to undergo HRPCI with either the Supira System (investigational device) or the commercially available Impella systems (comparator device).",[38,70,71,30],"High Risk Percutaneous Coronary Intervention","Interventional Cardiology",[73,74,30,75],"Percutaneous ventricular assist device","Supira System","US Pivotal","2026-06-10",{"date":78,"type":44},"2026-06-11",{"date":80,"type":44},"2026-05-11",{"date":82,"type":20},"2027-11",{"name":84,"class":51},"Supira Medical",14,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":61,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":116},"100638835","optimize-55---optimizing-impella-55-outcomes-through-advanced-data-science-100638835","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",{"count":95,"type":20},100,"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.",[98,30,99],"Cardiogenic Shock","Cardiogenic Shock Post Myocardial Infarction",[101,102,103,104,105],"cardiogenic shock","mechanical circulatory support","Impella 5.5","micro-axial flow pump","data science","2026-05-27",{"date":108,"type":44},"2026-06-01",{"date":110,"type":44},"2026-05-08",{"date":112,"type":20},"2029-05-30",{"name":114,"class":115},"Medical University of Vienna","OTHER",1,{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":17,"minAge":61,"maxAge":125,"enrollmentInfo":126,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":128,"conditions":129,"keywords":132,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":116},"100411735","noninvasive-cardiovascular-diagnosis-of-patients-with-fully-magnetically-levitated-blood-pumps-100411735","NCT04641416","Noninvasive Cardiovascular Diagnosis of Patients With Fully Magnetically Levitated Blood Pumps","Pilot Study: Noninvasive Cardiovascular Diagnosis of Patients With Fully Magnetically Levitated Blood Pumps","HM3_Snoopy","Inclusion Criteria:\n\nAll patients with the HeartMate 3 system implanted at the Medical University of Vienna, which are able and willing to understand and sign the informed consent form, and which do not meet any exclusion criteria will be included.\n\nExclusion Criteria:\n\n* Age: \\\u003C18 or \\>75 years\n* Inability to provide informed consent\n* Patients with known intraventricular or aortic root thrombus formation or known pathology of the coagulatory system. Although an intraventricular thrombus formation is usually removed intraoperatively during the LVAD implantation procedure, the rationale for this exclusion criterion is to avoid suction of such thrombus material during possible speed changes (± 20% from the initial pump speed). Consequently, the exclusion of patients with known pathology of the coagulation system, who thus have a higher risk of developing any kind of thrombus formation, is another safety measure.\n* Inaccessibility for transthoracic ultrasound diagnostics. Firstly, as described in the visit and assessment schedule (Appendix), changes in pump speed are only performed under transthoracic echo guidance. Secondly, as described above, echo parameters are required to correlate with the non-invasive CDAS pump data. Therefore, the inaccessibility of ultrasound diagnostics (e.g. due to poor image quality) is another exclusion criterion.","75 Years",{"count":127,"type":20},60,"Left Ventricular Assist Device (LVAD) therapy has become a well-established treatment option for endstage heart-failure either as a bridge to transplant (BTT) or destination therapy (DT). Monitoring of the pump and with this the cardiac status with the HeartMate 3 (HM3) is currently very limited to infrequent log-files with one data entry every 15 minutes and only limited amount of entries. Due to the low resolution data, the standard HM3 monitoring is not feasible for the evaluation of suction events or in depth analysis of the interaction between LVAD and the remaining native heart function. Aim of this study is to develop noninvasive diagnostics of the cardiac remaining respectively recovering function derived from HeartMate 3 pump data only and compare with standard clinical diagnostic procedures. These procedures include cardiac ultrasound and ECG. After this pilot study, the newly developed methods would allow frequent, simple and automatic monitoring of patients implanted with the HeartMate 3 device. Such continuous assessment of cardiac function would massively help therapy optimization of cardiac protection and, if possible, cardiac recovery.",[130,131,30],"End-stage Heart Failure","Cardiomyopathies",[133,134],"ventricular assist device","non-invasive monitoring","2026-05-05",{"date":110,"type":44},{"date":138,"type":44},"2020-07-09",{"date":140,"type":20},"2026-12-30",{"name":142,"class":115},"Thomas Schlöglhofer, PhD, MSc",{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":17,"minAge":61,"maxAge":151,"enrollmentInfo":152,"targetDuration":154,"studyType":21,"phases":4,"briefSummary":155,"conditions":156,"keywords":157,"overallStatus":162,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":4},"100633399","cerebral-oximetry-pulmonary-artery-catheter-parameters-and-ecmo-flow-in-patients-supported-with-veno-arterial-ecmo-100633399","NCT07526181","Cerebral Oximetry, Pulmonary Artery Catheter Parameters and ECMO Flow in Patients Supported With Veno-arterial ECMO","Cerebral Oximetry in Relation to Pulmonary Artery Catheter Parameters and Extracorporeal Membrane Oxygenation Flow in Patients Supported With Veno-arterial ECMO","ECMO","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Patients supported with veno-arterial ECMO.\n3. Presence of a pulmonary artery catheter.\n4. Expected ECMO support ≥ 24 hours.\n5. Patient with good echocardiographic window.\n\nExclusion Criteria:\n\n1. Pre-existing severe neurological injury (e.g. massive stroke, traumatic brain injury).\n2. Intracranial pathology affecting NIRS reliability.\n3. Facial or scalp conditions preventing NIRS probe placement.\n4. ECMO duration \\\u003C 48 hours.\n5. Poor echocardiographic window.","80 Years",{"count":153,"type":20},30,"5 Days","for patients connected to VA ECMO due to cardiogenic shock, monitoring:\n\n1. Cerebral Oximetry\n2. ECMO Parameters ECMO blood flow (L\u002Fmin) every 12 hours. Sweep gas flow Cannulation configuration\n3. Pulmonary Artery Catheter Data and hemodynamics:\n\n   Cardiac output \u002F cardiac index, SvO₂, Central venous pressure (CVP).\n4. other variables: P\u002FF ratio, MAP, Heart rate, Arterial blood gases, hemoglobin, Lactate, Vasopressor \u002F inotrope doses and Sedation score (RASS).\n5. Echocardiography parameters: recorded every 12 hours. LV ejection fraction. LVOT VTi. LVED dimension. Aortic valve opening.\n6. Follow-up data:\n\n   * ECMO duration.\n   * Need for oxygen therapy\u002Fmechanical ventilation.\n   * ICU survival.",[30],[158,159,160,161],"VA-ECMO","NIRS","native COP","ECMO flow","NOT_YET_RECRUITING","2026-04-10",{"date":165,"type":44},"2026-04-13",{"date":167,"type":20},"2026-04-20",{"date":169,"type":20},"2027-06-30",{"name":171,"class":115},"Assiut University",{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":17,"minAge":61,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":65,"phases":182,"briefSummary":183,"conditions":184,"keywords":188,"overallStatus":162,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":201},"100627230","palliative-care-intervention-to-improve-health-related-quality-of-life-for-patients-on-long-term-lvad-support-100627230","NCT07445932","Palliative Care Intervention to Improve Health Related Quality of Life for Patients on Long-Term LVAD Support","The PALL-VAD Study: Palliative Care Intervention to Improve Health Related Quality of Life for Patients With Heart Failure on Long-Term LVAD Support: A Pilot, Prospective, Randomized Trial","PALL-VAD","Inclusion Criteria:\n\n* LVAD patients \\>= 18 years of age\n* \\>= 1 year post-LVAD implantation\n\nExclusion Criteria:\n\n* Listed for heart transplantation. Undergoing evaluation for heart transplantation, however, is not an exclusion.\n* Non-English speaking\n* Receiving outpatient palliative care in the last 6 months\n* Renal replacement therapy\n* Non-cardiac terminal illness\n* Women who are pregnant or planning to become pregnant\n* Inability to comply with study protocol and follow up\n* Inabilty to provide consent.\n* Cognitive impairment or intellectual disability that prohibits successful completion of the HRQoL scales or compliance with the study protocol and follow up.",{"count":181,"type":20},90,[67],"Background: While left ventricular assist device (LVAD) therapy improves survival in patients with advanced heart failure (AHF), unique LVAD-related burdens may impact health-related quality of life (HRQoL). Palliative care specialists are key members of the multidisciplinary care team for patients with long-term-LVAD (LT-LVAD), offering specialized, comprehensive, holistic care.\n\nProblem: A seminal study of palliative care in patients with heart failure (PAL-HF trial) demonstrated that outpatient palliative care improved HRQoL, depression, anxiety, and spiritual well-being compared to usual care. The impact of longitudinal palliative care on HRQoL in LT-LVAD patients is unknown.\n\nObjective: The investigators aim to conduct the first study examining a palliative care intervention to improve HRQoL among LT- LVAD recipients (patients who have lived with LT-LVAD for at least six months and are not heart transplant candidates) at two centers (MedStar Health and Inova) in the Mid-Atlantic Region. Given the demographics of the study institutions, the investigators anticipate a socioeconomically and racially diverse cohort of patients with subgroups who may disproportionately experience LVAD-related burdens relative to benefits.\n\nAims: The first aim is to assess baseline measures of HRQoL in LT-LVAD patients to understand differences in HRQoL across subgroups and multiple, understudied domains. The second aim is to test the feasibility and acceptability of a randomized, unblinded pilot study of a palliative care interdisciplinary intervention in this population.\n\nSignificance: Results of this study will inform the development of a large randomized controlled trial to test the effectiveness of palliative care intervention in improving HRQoL in LT-LVAD patients. If results are positive, this will revolutionize the post-LVAD treatment paradigm, by making palliative care integration the standard of care for longitudinal LT-LVAD patient management.",[185,30,186,187],"Advanced Heart Failure","Left Ventricular Assist Device","Palliative Care",[189,190,191],"advanced heart failure","left ventricular assist device","palliative care","2026-02-25",{"date":194,"type":44},"2026-03-03",{"date":196,"type":20},"2026-03-01",{"date":198,"type":20},"2027-03-01",{"name":200,"class":115},"Medstar Health Research Institute",2,{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":17,"minAge":61,"maxAge":210,"enrollmentInfo":211,"targetDuration":4,"studyType":65,"phases":213,"briefSummary":215,"conditions":216,"keywords":218,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":116},"100527921","phase-2-cell-therapy-and-myocardial-recovery-in-heart-failure-patients-undergoing-left-ventricular-assist-device-support-100527921","NCT06154044","Cell Therapy and Myocardial Recovery in Heart Failure Patients Undergoing Left Ventricular Assist Device Support","The Effects of Cell Therapy on Myocardial Recovery in Chronic Heart Failure Patients Undergoing Left Ventricular Assist Device Support: A Pilot Trial (CELL-VAD Pilot)","CELL-VAD","Patient inclusion criteria will consist of all of the following:\n\n1. non-ischemic dilated cardiomyopathy\n2. patient accepted for LVAD support\n3. optimal (or maximal tolerable therapy) heart failure ≥ 2 months\n4. age 18-65 years\n5. ability to provide informed consent\n\nPatient exclusion criteria will consist of any of the following:\n\n1. ischemic cardiomyopathy\n2. Cardiomyopathy with a reversible cause that has not been treated e.g. thyroid disease, alcohol abuse, hypophosphataemia, hypocalcaemia, cocaine abuse, selenium toxicity \\& chronic uncontrolled tachycardia.\n3. Cardiomyopathy in association with a neuromuscular disorder e.g. Duchenne's progressive muscular dystrophy.\n4. ongoing or recent (less than 1 month) infection\n5. acute multi-organ failure\n6. clinically significant anemia (Hb \\\u003C 10 g\u002FdL)\n7. clinically significant leukopenia (L \\\u003C 2 x 109\u002FL) or leukocytosis (L \\> 14 x 109\u002FL)\n8. clinically significant thrombocytopenia (TRC \\\u003C 50 x 109\u002FL)\n9. known disorders of hemostasis that can not be corrected\n10. history of any thromboembolic complications\n11. chronic kidney disease (higher than stage III)\n12. chronic liver disease (Child B or C)\n13. diminished functional capacity for other reasons such as COPD, moderate or severe claudications, severe musculosceletal system pain or morbid obesity (BMI \\> 35 kg\u002Fm2)\n14. aortic stenosis (AVA \\\u003C 1.3 cm2) or ocluded aortic valve\n15. artificial (mechanical or biological) aortic valve\n16. patients with reduced immune response\n17. history of limphoprolipherative disorders or malignancy within 5 years\n18. left ventricular thrombus\n19. participation in another interventional clinical trial\n20. life expectancy less than 12 months\n21. known hypersensitivity to DMSO, penicillin or streptomycin","65 Years",{"count":212,"type":20},10,[214],"PHASE2","The goal of CELL-VAD Pilot trial is to investigate a personalized stem cell therapy approach for patients with advanced non-ischemic chronic heart failure (NICM) who are supported by LVAD. In the clinical trial, the investigators aim to enroll 10 patients with NICM, scheduled for LVAD implantation. After successful LVAD implantation, patients will be enrolled and followed for 2 months to allow for postoperative rehabilitation and heart failure medical therapy and LVAD support optimization. All patients will then undergo autologous CD34+ cell therapy which will be intracoronaryly delivered to the target myocardium using NOGA electromechanical mapping system. All patients will be followed for 6 months after cell therapy. At baseline, and at 1, 3, and 6 months after cell therapy, the investigators will perform comprehensive clinical evaluation.",[217,30],"Heart Failure",[219,102,220],"heart failure","stem cells","2026-01-22",{"date":223,"type":44},"2026-01-26",{"date":225,"type":44},"2022-05-01",{"date":227,"type":20},"2029-03-01",{"name":229,"class":115},"University Medical Centre Ljubljana",{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":17,"minAge":61,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":240,"conditions":241,"keywords":246,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":116},"100620203","prognosis-of-patients-with-mixed-cardiogenic-vasoplegic-shock-100620203","NCT07354568","Prognosis of Patients With Mixed Cardiogenic-Vasoplegic Shock","Prognosis of Patients With Mixed Cardiogenic-Vasoplegic Shock: a French Multicenter Cohort","PROMIX","Inclusion Criteria:\n\n* Adult patient (\\>18 years old)\n* Admitted to an intensive care unit for cardiogenic shock, at least SCAI stage C\n* No opposition to data use\n\nExclusion Criteria:\n\n* Missing key data, particularly regarding vasopressor doses and outcomes.\n* Pregnant women\n* Non-eligible shock etiologies, including but not limited to:\n* Anaphylactic shock,\n* Isolated hemorrhagic shock,\n* Severe burns or major trauma,\n* Severe acute pancreatitis,\n* Fulminant hepatic failure,\n* Neurogenic shock.\n* Adult under legal protection (guardianship, curatorship, or judicial protection).",{"count":239,"type":20},2500,"Mixed cardiogenic-vasoplegic shock (M-CS) represents a distinct and severe phenotype of cardiogenic shock characterized by concomitant myocardial dysfunction and inappropriate systemic vasodilation. Despite its clinical relevance, the epidemiology, management, and outcomes of M-CS remain poorly defined.\n\nThis retrospective, multicenter, observational registry aims to evaluate the clinical outcomes and prognostic factors associated with mixed cardiogenic-vasoplegic shock. The study will analyze clinical, biological, and invasive hemodynamic data routinely collected during patient management for M-CS.\n\nAll included patients will have been admitted for cardiogenic shock, with or without vasoplegia, defined by low cardiac output and, when present, decreased systemic vascular resistance despite adequate filling pressures requiring vasopressor support.\n\nThe primary objective is to describe mortality and organ failure rates, while secondary analyses will identify determinants of adverse outcomes and potential phenotypic subgroups.\n\nThe PROMIX registry will be conducted across three French university hospitals (CHU Amiens-Picardie, CHU Dijon-Bourgogne, and CHU Rouen-Normandie).\n\nThis study is non-interventional, involving only data obtained as part of routine critical care, and will provide the first multicenter overview of this complex and underrecognized form of cardiogenic shock.",[242,243,244,30,245,99],"Cardiogenic Shock Acute","Bypass, Cardiopulmonary","Septic Shock","Myocardial Infarction (MI)",[158,98,30,247,248,249],"Vasopressor","Mixed Cardiogenic Shock","post cardiotomy shock","2026-01-15",{"date":252,"type":44},"2026-01-21",{"date":254,"type":44},"2025-10-20",{"date":256,"type":20},"2027-06-01",{"name":258,"class":115},"Centre Hospitalier Universitaire, Amiens",{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":17,"minAge":61,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":268,"conditions":269,"keywords":4,"overallStatus":162,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":116},"100617793","hong-kong-cardiogenic-shock-initiative-100617793","NCT07323238","Hong Kong Cardiogenic Shock Initiative","HK CSI","Inclusion Criteria:\n\n* Diagnosis of acute myocardial infarction (AMI) with the ECG and\u002For biomarker evidence of S-T elevation myocardial infarction (STEMI) or non -S-T elevation myocardial infarction (NSTEMI)\n* Cardiogenic Shock is defined as presence of at least two of the following\n\n  1. Hypotension (systolic blood pressure ≤ 100 mmHg, or inotropes\u002Fvasopressors to maintain systolic blood pressure ≥ 100 mmHg)\n  2. Evidence of end organ perfusion: elevated serum lactate levels (venous or arterial), cool extremities, oliguria\u002Fanuria\n  3. Hemodynamic criteria represented by cardiac index of \\\u003C2.2 L\u002Fmin\u002Fm² or a cardiac ≤ 0.6 watts\n* Patient is supported with a transvalvular MCS as the initial device (criteria for GCSI-eligible Cohort)\n* Patients undergo PCI within 12 hours of hospital presentation (criteria for GCSI-eligible Cohort)\n* Subject or legally designated representative (LDR) has provided written informed consent. For patients not able to provide consent, data collection will be conducted in retrospective manner with study consent waived.\n\nExclusion Criteria:\n\n* Unwitnessed out of hospital cardiac arrest or any cardiac arrest in which return of spontaneous circulation (ROSC) is not achieved within 20 minutes\n* Patients demonstrate any signs of anoxic brain injury prior to the INDEX PCI (signs of anoxic injury include, posturing, seizures).\n* IABP placed prior to MCS (criteria for GCSI-eligible Cohort)\n* Septic, anaphylactic, hemorrhagic, and neurologic causes of shock\n* Non-ischemic causes of shock\u002Fhypotension (pulmonary embolism, pneumothorax, myocarditis, tamponade, etc.)\n* Active bleeding for which MCS in contraindicated\n* Recent major surgery for which MCS is contraindicated\n* Mechanical complication of AMI (acute ventricular septal defect (VSD) or acute papillary muscle rupture)\n* Known left ventricular thrombus for which MCS in contraindicated (criteria for GCSI-eligible Cohort)\n* Mechanical aortic prosthetic valve (criteria for GCSI-eligible Cohort)\n* Contraindication to intravenous systemic anticoagulation which precludes placement of MCS.\n\nPatients who fulfills all Eligibility Criteria would be recruited and considered GSCI-eligible. AMI-CS patients that did not use MCS, ie. Not fulfiliing both Inclusion Criteria 3, 4, would not be considered screen failure and would still be screened and recruited into HKCSI GCSI-ineligible cohort. Likewise, patients who meet any of Exclusion Criteria will not be GCSI-eligible. Specifically, patients who met exclusion criteria 3, 9, 10 only will be recruited into GCSI-ineligible cohort.",{"count":267,"type":20},320,"Acute myocardial infarction complicated by cardiogenic shock (AMI-CS) is a severe condition with high mortality. Early revascularization and Impella device (Abiomed) support improve outcomes. Observational studies like the National Cardiogenic Shock Initiative (NCSI), Inova-Shock registry, and J-PVAD (Japan registry for percutaneous ventricular assist device) registry emphasize the importance of structured care systems when using mechanical circulatory support (MCS).\n\nFollowing the release of the Danger Shock trial, MCS use is expected to rise. Hospitals will need to monitor practices and work with payers to ensure coverage. Using regional real-world data can assist this process, making the collection and analysis of MCS outcomes essential.\n\nThe NCSI (NCT03677180) aimed to evaluate outcomes with a protocolized approach prioritizing rapid diagnosis, timely MCS delivery, and invasive hemodynamic monitoring via pulmonary artery (PA) catheters. The study involved 406 patients from 2016 to 2020, with an average age of 64 years. Most (67%) had shock, with 85% on vasoactive drugs. Witnessed outof-hospital cardiac arrest occurred in 17%, and in-hospital arrest in 30%. During MCS implantation, 9% were actively resuscitating. Patients mostly in SCAI stage C\u002FD (73%) and stage E (27%) presented with low blood pressure, high lactate, and reduced cardiac power output. About 70% received MCS before PCI, with 90% using PA catheters. Most had STEMI, with median door-to-support and door-to-balloon times of about 78 and 81 minutes. Survival rates were high: 99% procedural, 79% to discharge, 77% at 30 days, and 62% at one year for stage C\u002FD shock. Patients with stage E shock had lower survival. Early use of MCS improved hemodynamics and survival. Further research, like the CERAMICS (Can Escalation Reduce Acute Myocardial Infarction in Cardiogenic Shock) study, aims to refine escalation strategies. The Danger Shock trial highlighted the importance of minimizing complications such as bleeding, limb ischemia, haemolysis, and kidney injury.\n\nCurrently in Hong Kong, prevalence of CS among AMI patients is 5-10%, in-line with global statistics. Among which, 30-day and 1-year mortality of AMI-CS patients in Hong Kong was reported at 29% and 39.5% respectively. Although the use of MCS has been shown in the above overseas studies to improved survival rates of AMI-CS patients, the utilisation rate of MCS among AMI-CS patients in Hong Kong was reported at 36.5% in a previous single-centre study, limited by an array of factors including limited device availability, allocations of resources and patient selection strategy, lack of region-specific evidence and device affordability. Global Cardiogenic Shock Initiative (GCSI) is an ongoing international multicenter registry involving centers from USA, Germany, and Hong Kong, and focus on the outcomes of AMI-CS patients received Impella support. The GCSI is expanding to many other regions. In the Hong Kong Cardiogenic Shock Initiative (HK-CGSI) study we aim to include sites with experience in MCS, all of whom have the capability of MCS escalation and evaluate outcomes across these centers.\n\nThe goal is not only to capture the effects of previously established best practices but gain insights into regional best practices, and together with data from the global cardiogenic shock initiative (GCSI), to better establish the adoption of novel best practices and their effect on complication rates.\n\nIn parallel to GCSI-eligible cohort, i.e. Impella used as the first supporting device for patients with AMI-CS, given the significant portion of patients who could not receive MCS under current limitations in Hong Kong, in the HK-CSI, we will include also the GCSI-ineligible cohort, i.e. AMI-CSI without using Impella or not as the first MCS used, to understand the full picture of clinical outcomes of AMI-CS patients of Hong Kong.\n\nThe HK-CSI study is an observational registry solely and not a treatment study. This single-arm registry captures data generated during procedures which are considered standard of care. Participation in this registry will be performed with waiver of consent of the patient and will have no influence on the type and extent of treatment.",[242,270,98,99,30],"STEMI - ST Elevation Myocardial Infarction","2026-01-07",{"date":273,"type":44},"2026-01-09",{"date":275,"type":20},"2026-04-01",{"date":277,"type":20},"2030-10-02",{"name":279,"class":115},"Prince of Wales Hospital, Shatin, Hong Kong"]