[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shenzhen Core Medical Technology CO.,LTD.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":162},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,44,68,92,113,136],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100651187","a-prospective-multicentersingle-arm-study-of-duocor-2-ventricular-assist-system-for-the-treatment-of-advanced-biventricular-heart-failure-100651187",false,"NCT07757451","A Prospective, Multicenter,Single-arm Study of DuoCor 2 Ventricular Assist System for the Treatment of Advanced Biventricular Heart Failure","Inclusion Criteria:\n\n* 1.18 years ≤ Age ≤ 75 years\n* 2.INTERMACS Class 1-2\n* 3.Patient is inotrope dependent, OR has a Cardiac Index (CI) \\\u003C 2.2 L\u002Fmin\u002Fm2, while not on inotropes\n* 4\\. Patient has reduced exercise capacity due to cardiac factors with at least one of the following criteria:\n\n  * Unable to exercise\n  * 6-minute walking test (6MWT) \\\u003C 300 meters\n* 5.Patient has right heart failure related symptoms such as lower limbs edema, jugular vein distension\n* 6.Patient has advanced, irreversible biventricular heart failure and is deemed to be eligible for biventricular mechanical circulatory support by clinical expertise.\n* 6a: advanced left heart failure\n\n  * Left ventricular ejection fraction (LVEF) ≤ 30%;\n  * Pulmonary capillary wedge pressure (PCWP) \\> 15mmHg.\n* 6b: severe right heart failure despite guideline-directed medical therapy. This includes at least one evaluation index of right ventricular function and at least one evaluation index of volume load or structural abnormality:\n\n  * Evaluation index of right ventricular function:\n* Right ventricular ejection fraction (RVEF)≤ 30%;\n* Right ventricular stroke work index (RVSWI)≤ 0.25 mmHg\\*L\u002Fm2;\n* Right ventricle fractional area change(RVFAC) \\\u003C 30%;\n\n  * Evaluation index of volume load or structural abnormality:\n* Central venous pressure (CVP)\\> 15 mmHg;\n* CVP to PCWP ratio\\> 0.63;\n* Moderate to severe tricuspid regurgitation;\n* Right ventricular (RV) to left ventricular (LV) end-diastolic diameter ratio\\> 0.72;\n* Tricuspid annular plane systolic excursion (TAPSE)≤ 14 mm;\n* Pulmonary artery pressure index (PAPi)\\\u003C 2.\n* 7.Patient or its legal representative has signed the informed consent, has full understanding of procedures and the study, and is committed to following study requirements.\n\nExclusion Criteria:\n\n* 1.Known intolerance to anticoagulant or antiplatelet therapies.\n* 2.Etiology of heart failure due to restrictive or constrictive physiology (e.g., hypertrophic cardiomyopathy, cardiac amyloidosis \u002Fsenile or other infiltrative heart disease)\n* 3.Coagulopathy defined by platelets \\\u003C 100\\*10\\^9\u002FL or INR ≥ 1.5 not due to anticoagulant therapy.\n* 4\\. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator.\n* 5\\. Presence of temporary mechanical circulatory support such as Impella (all types) or IABP with a duration greater than 21 days.\n* 6\\. Presence of ECMO with a duration greater than 10 days.\n* 7.Moderate to severe aortic valve regurgitation or pulmonary valve regurgitation, and refusal of bioprosthetic valve replacement.\n* 8.Presence of mechanical aortic valve or pulmonary valve, and refusal of bioprosthetic valve replace.\n* 9\\. Patient is implanted with durable mechanical circulatory support (LVAD or RVAD) and has refused to switch to the study device.\n* 10\\. Patient experienced cerebrovascular accident (CVA) within 3 months of eligibility evaluation.\n* 11\\. Presence of significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration.\n* 12\\. Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:\n\n  * Total bilirubin \\> 3.0 mg\u002FdL or cirrhosis confirmed by imaging or positive biopsy;\n  * Glomerular filtration rate (GFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m2 or renal replacement therapy dependence;\n  * History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1\u002FFVC \\\u003C 0.7, and FEV1 \\\u003C 50% predicted.\n* 13\\. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units.\n* 14\\. Severe systemic light-chain amyloidosis.\n* 15\\. Blood stream infection within 7 days. Positive blood cultures reflective of contaminants (e.g., Staphylococcus epidermidis) will not be considered an exclusion.\n* 16\\. Sepsis\n* 17\\. History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) \\> 5 cm in diameter.\n* 18.Any condition other than HF that could limit survival to less than 24 months.\n* 19.Positive pregnancy test if of childbearing potential, lactating mothers.\n* 20.Presence of psychiatric disorders, irreversible cognitive impairment, or psychosocial issues that may compromise their ability to comply with the study protocol and management requirements for implantable ventricular assist devices, or brain death due to any cause.\n* 21\\. Participation in any other clinical investigation that is likely to confound study results or affect the study.\n* 22.Ineligibly based on physician's judgement due to other severe conditions or other conditions which can interfere with subject's compliance to the study.","ALL","18 Years","75 Years",{"count":19,"type":20},64,"ESTIMATED","INTERVENTIONAL",[23],"NA","The objective of this clinical investigation is to evaluate the safety and efficacy of the DuoCor 2 Ventricular Assist System (DuoCor 2 VAS) in subjects with advanced biventricular heart failure requiring circulatory support.\n\nEach subject receiving the DuoCor 2 VAS will be evaluated at 6 months (180 days) for primary and secondary endpoints with further follow-up assessments up to 2 years.",[26],"Advanced Heart Failure",[28,29,30],"Biventricular Heart Failure","Biventricular Assist Device","Mechanical Circulatory Support","NOT_YET_RECRUITING","2026-08-05",{"date":34,"type":35},"2026-08-11","ACTUAL",{"date":37,"type":20},"2026-10",{"date":39,"type":20},"2030-01",{"name":41,"class":42},"Shenzhen Core Medical Technology CO.,LTD.","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":4},"100645502","corheart-6-lvas-clinical-investigation-100645502","NCT07700810","Corheart 6 LVAS Clinical Investigation","A Prospective, Multicenter, Single-arm Clinical Investigation of the Corheart 6 Left Ventricular Assist System","Inclusion Criteria:\n\n* Age ≥ 18 years and ≤ 75 years\n* The patient has signed an Informed Consent Form\n* Body Surface Area (BSA) ≥ 1.2 m2\n* New York Heart Association (NYHA) Class IV\n* Left Ventricular Ejection Fraction (LVEF) ≤ 25%\n* Despite the optimal medical management based on current guidelines, the patient must also meet one or more of the following:\n* \\- - a. Unable to exercise for HF, or if able to perform cardiopulmonary testing, with peak VO2 \\\u003C12 mL\u002Fkg\u002Fmin and\u002For \\\u003C 50% predicted value;\n* \\- - b. Progressive end-organ dysfunction (worsening renal and\u002For hepatic function, type II pulmonary hypertension, cardiac cachexia) due to reduced perfusion and not to inadequately low ventricular filling pressure (PCWP \\> 20 mmHg and SBP \\\u003C 90 mmHg or CI \\\u003C 2.0 L\u002Fmin\u002Fm2).\n* \\- - c. Impella or IABP assisted; Inotrope dependent\u002Funable to wean from inotropes.\n\nExclusion Criteria:\n\n* Heart failure who can be treated with other therapy options (e.g. CRT, CRT-D, etc.)\n* Intolerance to anticoagulant or antiplatelet therapies or any other peri\u002Fpost-operative therapy the investigator will require based upon the patients' health status.\n* Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia type II.\n* Platelet count \\\u003C 100,000 x 103\u002FL (\\\u003C 100,000\u002Fml).\n* Psychiatric disease\u002F disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and left ventricular assist system management.\n* Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator.\n* Presence of an active, uncontrolled infection.\n* Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:\n* \\- - a. Total bilirubin \\> 51.3 umol\u002FL (3.0 mg\u002Fdl), ischemic hepatitis, or biopsy proven liver cirrhosis, or clinically Child-Pugh B and C score.\n* \\- - b. History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1\u002FFVC \\\u003C 0.7, or FEV1 \\\u003C 50% predicted.\n* \\- - c. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention.\n* \\- - d. History of stroke within 180 days prior to enrollment, or a history of cerebrovascular disease with symptomatic (\\> 70%) carotid artery stenosis\n* \\- - e. Serum creatinine ≥ 265umol\u002FL (3.0mg\u002Fdl) or requiring dialysis.\n* \\- - f. Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration.\n* Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive\u002F restrictive cardiomyopathy, pericardial disease, amyloidosis or giant cell myocarditis.\n* Uncorrected moderate to severe aortic insufficiency without plans for correction during pump implant.\n* History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) \\> 5 cm in diameter.\n* Uncontrollable ventricular tachyarrythmias \u002F ventricular fibrillation (VF).\n* STEMI \\\u003C2 weeks before planned implantation.\n* Right ventricular failure as defined by one or more of the following:\n* \\- - a. Severe depressed RV function in echocardiography\n* \\- - b. TAPSE \\\u003C 1.0 cm\n* \\- - c. CVP\u002FPCWP ratio \\> 0.63\n* Planned Bi-VAD support prior to enrollment.\n* Cardiac arrest with a history of resuscitation 1-month before inclusion, without full restoration of cognitive function.\n* History of any organ transplant.\n* Pre albumin \\\u003C 150 mg\u002FL, or Albumin \\\u003C 30g\u002FL (3 g\u002FdL).\n* Any condition other than HF that could limit survival to less than 24 months\n* Positive pregnancy test if of childbearing potential.\n* Lactating mothers.\n* Participation in any other clinical investigation that is likely to confound study results or affect the study.\n* Patients who have been placed in an institution by court order or by order of the authorities.",{"count":52,"type":20},100,[23],"To evaluate the safety and effectiveness of the Corheart 6 left ventricular assist system in providing mechanical support for blood circulation in patients with advanced left ventricular heart failure.",[56],"Advanced Left Ventricular Heart Failure",[58,26,59,30],"advanced left ventricular heart failure","Left Ventricular Assist System","2026-07-15",{"date":62,"type":35},"2026-07-17",{"date":64,"type":20},"2027-01-31",{"date":66,"type":20},"2034-01-31",{"name":41,"class":42},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},"100647124","safety-and-feasibility-of-the-corvad-percutaneous-ventricular-assist-system-in-refractory-right-heart-failure-100647124","NCT07704424","Safety and Feasibility of the CorVad Percutaneous Ventricular Assist System in Refractory Right Heart Failure","Inclusion Criteria:\n\n1. Patients who develop refractory right heart failure within 48 hours after left ventricular assist device (LVAD) implantation, myocardial infarction, heart transplantation, or open-heart surgery, defined as:\n\n   * despite ongoing treatment with oral heart failure medications, including continuous infusion of high-dose inotropic agents and\u002For vasopressors, and\u002For the use of more than one inotropic agent and\u002For vasopressor, the cardiac index (CI) remains less than 2.2 L\u002Fmin\u002Fm²;\n   * and meets any one of the following criteria: 1) CVP \\> 15 mmHg; or, 2) CVP\u002Fpulmonary capillary wedge pressure (PCWP) or CVP\u002Fleft atrial pressure (LAP) \\> 0.63; or, 3) echocardiographic evidence of moderate-to-severe right ventricular dysfunction meeting one of the following criteria: right ventricular basal diameter \\> 42 mm, right ventricular short-axis (or mid-chamber) diameter \\> 35 mm, tricuspid annular systolic excursion (TAPSE) score \\\u003C 14 mm, right ventricular fractional area change (FAC) \\\u003C 30%, tricuspid annular systolic peak velocity (TDI S') \\\u003C 9 cm\u002Fs, and right ventricular free wall longitudinal strain \\> -20%.\n2. ≥ 18 years old.\n3. The patient or the patient's legal representative agrees to sign the informed consent form.\n\nExclusion Criteria:\n\n1. INTERMACS Stage 1 is defined as: despite the use of inotropic agents (positive inotropic drugs) and\u002For temporary mechanical support (such as IABP or ECMO), the patient remains hypotensive and shows signs of inadequate perfusion of vital organs (such as oliguria or worsening liver function), requiring immediate initiation of mechanical circulatory support to survive.\n2. Severe hepatic or renal dysfunction, defined as total bilirubin ≥ 5 mg\u002FdL or creatinine ≥ 4 mg\u002FdL within 24 hours prior to treatment with the investigational device.\n3. For patients who have undergone LVAD implantation, acute neurological injury occurring after implantation, including stroke, hypoxic encephalopathy, or acute neurological deficits (such as seizures or altered levels of consciousness).\n4. Acute myocardial infarction with mechanical complications, including ventricular septal defect, cardiac rupture, or papillary muscle rupture.\n5. Failed revascularization (for patients requiring right coronary revascularization), defined as a TIMI blood flow grade of 0 or 1 following percutaneous coronary intervention or coronary artery bypass grafting.\n6. Active infection, meeting at least two of the following criteria: white blood cell count \\> 12,500\u002FμL, positive blood culture, or fever.\n7. Thrombus in the right atrium, right ventricle, and\u002For pulmonary artery.\n8. History of mechanical valve replacement of the tricuspid or pulmonary valve.\n9. Severe tricuspid stenosis or regurgitation.\n10. Severe pulmonary valve stenosis or regurgitation.\n11. Severe pulmonary hypertension, defined as a pulmonary artery systolic pressure \\> 60 mmHg.\n12. Current diagnosis of pulmonary embolism.\n13. History of pulmonary artery graft replacement (artificial vessel).\n14. Current use of a right heart assist device or extracorporeal membrane oxygenation (ECMO) device.\n15. Thrombosis of the internal jugular vein and deep veins of the lower extremities, and\u002For the presence of a vena cava filter.\n16. Anatomical conditions that interfere with pump implantation or the safe use of the device, such as aortic dissection, Marfan syndrome, Erdheim-Chirlow disease (i.e., idiopathic medial necrosis, commonly associated with aortic dissection), etc.\n17. Congenital heart disease that precludes device implantation, or an unrepairated atrial septal defect or patent foramen ovale.\n18. Allergy or intolerance to contrast agents, or intolerance to anticoagulant or antiplatelet therapy.\n19. History of thrombolytic therapy within the past 30 days, known coagulation disorders, or hematologic disorders causing blood cell fragility or hemolysis.\n20. Female patients who are pregnant or breastfeeding.\n21. Participation in any other clinical trial that may confound the study results or affect the study outcomes.\n22. Other circumstances deemed by the investigator to be incompatible with inclusion in this study.",{"count":5,"type":20},[23],"The goal of this clinical trial is to evaluate the safety and feasibility of the CorVad Percutaneous Ventricular Assist System (Device model: CorVad RS) in patients with right heart failure who continue to experience hemodynamic instability despite best medical therapy.",[78],"Right Heart Failure",[80,81,82],"Right heart failure","pVAD","CorVad","RECRUITING","2026-07-14",{"date":60,"type":35},{"date":87,"type":35},"2026-06-02",{"date":89,"type":20},"2027-02-28",{"name":41,"class":42},2,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":102,"conditions":103,"keywords":104,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":43},"100610922","duocor-2-dominate-study-100610922","NCT07233876","DuoCor 2 DOMINATE Study","A Prospective, Multi-Center, Single-Arm Study for the Evaluation of the DuOCor 2 Ventricular Assist SysteM In Patients With AdvaNced BIventriCulAr HearT FailurE","Inclusion Criteria:\n\n* 1\\. Age ≥ 18 years and ≤ 75 years\n* 2\\. Patient is inotrope dependent, OR has a Cardiac Index (CI) \\\u003C 2.2 L\u002Fmin\u002Fm2, while not on inotropes\n* 3\\. Patient has left heart failure with at least one of the following criteria:\n* Left ventricular ejection fiction (LVEF) ≤ 30%;\n* Pulmonary capillary wedge pressure (PCWP) \\> 15mmHg.\n* 4\\. Patient has severe, irreversible biventricular heart failure and is eligible for biventricular mechanical circulatory support based on the ISHLT guideline. This includes at least two of the following hemodynamic and\u002For echocardiographic measurements:\n* Right ventricular ejection fraction (RVEF)≤ 30%;\n* Right ventricular stroke work index (RVSWI)≤ 0.25 mmHg\\*L\u002Fm2;\n* Tricuspid annular plane systolic excursion (TAPSE)≤ 14 mm;\n* Right ventricular (RV) to left ventricular (LV) end-diastolic diameter ratio\\> 0.72;\n* Central venous pressure (CVP)\\> 15 mmHg;\n* CVP to PCWP ratio\\> 0.63;\n* Tricuspid insufficiency grade 2-4;\n* Pulmonary artery pressure index (PAPi)\\\u003C 2;\n* 5\\. Patient or its legal representative has signed the informed consent, has full understanding of procedures and the study, and is committed to following study requirements.\n\nExclusion Criteria:\n\n* 1\\. Known intolerance to anticoagulant or antiplatelet therapies.\n* 2\\. Etiology of heart failure due to restrictive or constrictive physiology (e.g., hypertrophic cardiomyopathy, cardiac amyloidosis \u002Fsenile or other infiltrative heart disease).\n* 3\\. Coagulopathy defined by platelets \\\u003C 100k\u002Fµl or INR ≥ 1.5 not due to anticoagulant therapy.\n* 4\\. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator.\n* 5\\. Presence of temporary mechanical circulatory support such as Impella (all types) or IABP with a duration greater than 21 days.\n* 6\\. Presence of ECMO with a duration greater than 10 days.\n* 7\\. Patient is implanted with durable mechanical circulatory support (LVAD or RVAD) and has refused to switch to the study device.\n* 8\\. Patient experienced cerebrovascular accident (CVA) within 3 months of eligibility evaluation.\n* 9\\. Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:\n* Total bilirubin \\> 3.0 mg\u002FdL or cirrhosis confirmed by imaging or positive biopsy;\n* Glomerular filtration rate (GFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m2 or renal replacement therapy dependence;\n* History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1\u002FFVC \\\u003C 0.7, or FEV1 \\\u003C 50% predicted.\n* Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration;\n* 10\\. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units.\n* 11\\. Severe systemic light-chain amyloidosis.\n* 12\\. Blood stream infection within seven days. Positive blood cultures reflective of contaminants (e.g., Staphylococcus epidermidis) will not be considered an exclusion.\n* 13\\. Sepsis\n* 14\\. History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) \\> 5 cm in diameter.\n* 15\\. Any condition other than HF that could limit survival to less than 24 months.\n* 16\\. Positive pregnancy test if of childbearing potential.\n* 17\\. Lactating mothers.\n* 18\\. Participation in any other clinical investigation that is likely to confound study results or affect the study.",{"count":100,"type":20},50,[23],"Advanced heart failure is a life-threatening condition characterized by the inability of one or both ventricles to maintain adequate blood circulation. In such cases, medical treatments often prove ineffective, necessitating advanced treatment. Heart transplantation is the standard treatment for these patients, but it is severely limited by the shortage of donor hearts. As a result, mechanical circulatory support (MCS) devices are often employed. However, the most common form, the left ventricular assist device (LVAD), is only suitable for patients with isolated left ventricular dysfunction. This leaves a significant treatment gap for patients with biventricular failure. For this population, current options, such as total artificial hearts (TAHs) and biventricular assist devices (BiVADs), are associated with significant challenges, including high rates of adverse events and suboptimal long-term outcomes.\n\nThe DuoCor Ventricular Assist System (VAS) is a next-generation MCS device specifically developed to address this need by providing simultaneous biventricular support. It incorporates two compact, good hemocompatible blood pumps designed for implantation in both the left and right heart, controlled via a single driveline and external controller. It aims to reduce surgical complexity, improve patient mobility, and minimize complications such as thrombosis and infection.\n\nThe primary objective of this study is to evaluate the safety and efficacy of the DuoCor VAS as a treatment for advanced biventricular heart failure.",[26],[30,28,29],"2026-04-21",{"date":107,"type":35},"2026-04-24",{"date":109,"type":20},"2026-04-01",{"date":111,"type":20},"2029-04-01",{"name":41,"class":42},{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":120,"targetDuration":4,"studyType":21,"phases":122,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},"100506562","corheart-6-lvas-study-100506562","NCT05876000","Corheart 6 LVAS Study","Prospective Multi-Center Single-Arm Study for Evaluating the Corheart 6 Left Ventricular Assist System","Inclusion Criteria:\n\n* 1\\. Age ≥ 18 years and ≤ 75 years\n* 2\\. The patient has signed an Informed Consent Form\n* 3\\. Body Surface Area (BSA) ≥ 1.2 m\\^2\n* 4\\. New York Heart Association (NYHA) Class IV\n* 5\\. Left Ventricular Ejection Fraction (LVEF) ≤ 25%\n* 6\\. Despite the optimal medical management based on current guidelines, the patient must also meet one or more of the following:\n* a. Unable to exercise for HF,\n* or\n* if able to perform cardiopulmonary testing, with peak VO2 \\\u003C12 mL\u002Fkg\u002Fmin and\u002For \\\u003C 50% predicted value;\n* b. Progressive end-organ dysfunction (worsening renal and\u002For hepatic function, type II pulmonary hypertension, cardiac cachexia) due to reduced perfusion and not to inadequately low ventricular filling pressure (PCWP \\> 20 mmHg and SBP \\\u003C 90 mmHg or CI \\\u003C 2.0 L\u002Fmin\u002Fm2).\n* c. Impella or IABP assisted;\n* d. Inotrope dependent\u002Funable to wean from inotropes.\n\nExclusion Criteria:\n\n* 1\\. Heart failure who can be treated with other therapy options (e.g. CRT, CRT-D, etc.)\n* 2\\. Intolerance to anticoagulant or antiplatelet therapies or any other peri\u002Fpost-operative therapy the investigator will require based upon the patients' health status.\n* 3\\. Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia type II.\n* 4\\. Platelet count \\\u003C 100,000 x 10\\^3\u002FL (\\\u003C 100,000\u002Fml).\n* 5\\. Psychiatric disease\u002F disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and ventricular assist system management.\n* 6\\. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator.\n* 7\\. Presence of an active, uncontrolled infection.\n* 8\\. Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:\n* a. Total bilirubin \\> 51.3 μmol\u002FL (3.0 mg\u002Fdl), ischemic hepatitis, or biopsy proven liver cirrhosis, or clinically Child-Pugh B and C score.\n* b. History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1\u002FFVC \\\u003C 0.7, or FEV1 \\\u003C 50% predicted.\n* c. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention.\n* d. History of stroke within 180 days prior to enrollment, or a history of cerebrovascular disease with symptomatic (\\> 70%) carotid artery stenosis\n* e. Serum creatinine ≥ 265 μmol\u002FL (3.0mg\u002Fdl) or requiring dialysis.\n* f. Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration.\n* 9\\. Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive\u002F restrictive cardiomyopathy, pericardial disease, amyloidosis or giant cell myocarditis.\n* 10\\. Uncorrected moderate to severe aortic insufficiency without plans for correction during pump implant.\n* 11\\. History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) \\> 5 cm in diameter.\n* 12\\. Uncontrollable ventricular tachyarrythmias\u002F ventricular fibrillation (VF).\n* 13\\. STEMI \\\u003C2 weeks before planned implantation.\n* 14\\. Right ventricular failure as defined by one or more of the following:\n* a. severe depressed RV function in echocardiography\n* b. TAPSE \\\u003C 1.0 cm\n* c. CVP\u002FPCWP ratio \\> 0.63\n* 15\\. Planned Bi-VAD support prior to enrollment.\n* 16\\. Cardiac arrest with a history of resuscitation 1-month before inclusion, without full restoration of cognitive function.\n* 17\\. History of any organ transplant.\n* 18\\. Pre albumin \\\u003C 150 mg\u002FL, or Albumin \\\u003C 30g\u002FL (3 g\u002FdL).\n* 19\\. Any condition other than HF that could limit survival to less than 24 months.\n* 20\\. Positive pregnancy test if of childbearing potential.\n* 21\\. Lactating mothers.\n* 22\\. Participation in any other clinical investigation that is likely to confound study results or affect the study.\n* 23\\. Patients who have been placed in an institution by court order or by order of the authorities.",{"count":121,"type":20},53,[23],"The primary objective of this study is to evaluate the safety and effectiveness of the Corheart 6 LVAS when used for the treatment of advanced left ventricular heart failure in a European population at 6 months post-implantation.\n\nThe secondary objective is to assess the long-term safety and effectiveness of Corheart 6 LVAS treatment.",[125],"Refractory Heart Failure",[26,59,30],"2026-01-06",{"date":129,"type":35},"2026-01-08",{"date":131,"type":35},"2024-05-14",{"date":133,"type":20},"2031-06-30",{"name":41,"class":42},11,{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":144,"sex":15,"minAge":16,"maxAge":145,"enrollmentInfo":146,"targetDuration":4,"studyType":21,"phases":148,"briefSummary":149,"conditions":150,"keywords":152,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":43},"100584190","corvad-myocardial-infarction-complicated-with-cardiogenic-shock-trial-100584190","NCT06886113","CorVad Myocardial Infarction Complicated with Cardiogenic Shock Trial","Effects of CorVad Percutaneous Mechanical Circulatory Support in Patients with ST Segment Elevation Myocardial Infarction Complicated by Cardiogenic Shock.","Corvad AMICS","Inclusion Criteria:\n\n1. ST segment elevation myocardial infarction of less than 36 hours' duration, confirmed by new onset ST-segment elevation, or emergency angiography demonstrating acute occlusion of coronary artery, and\n2. Cardiogenic shock of less than 24 hours' duration, confirmed by:\n\n   peripheral signs of tissue hypoperfusion (arterial blood lactate ≥2.5mmol\u002Fl and\u002For SvO2 \\\u003C55% with a normal PaO2) and systolic blood pressure less than 100mmHg and\u002For need for vasopressor therapy (dopamine\u002F norepinephrine or epinephrine), and\n3. Left ventricular ejection fraction of less than 45% visually estimated or by wall motion score index \\>1,6.\n\nExclusion Criteria:\n\n1. Shock duration N24 hours\n2. Other causes of shock; hypovolemia, sepsis, pulmonary embolism or anaphylaxis\n3. Shock due to mechanical complication to myocardial infarction; papillary muscle rupture, rupture of the ventricular septum or rupture of ventricular free wall.\n4. Severe aorta valve regurgitation\u002Fstenosis\n5. Severe peripheral arterial obstructive disease that would preclude Impella device placement\n6. Mechanical aortic valve prosthesis\n7. Already established mechanical circulatory support (Impella or VA-ECMO)\n8. Left ventricular thrombus\n9. Infective endocarditis\n10. Shock due to right ventricular failure\n11. Out of hospital cardiac arrest with persistent Glasgow coma scale b8 after return of spontaneous circulation. Cardiac arrest occurring in ambulance or after arrival to hospital is not an exclusion criterion.\n12. Subject with documented heparin induced thrombocytopenia.\n13. Life expectancy of less than 1 year due to comorbidities.\n14. Mental disorder or language barrier that preclude informed",true,"80 Years",{"count":147,"type":20},269,[23],"Cardiogenic shock a serious complication of a heart attack (myocardial infarction). Despite evaluation of several new treatments during the last decade, the mortality in patients with cardiogenic shock still exceeds 50%. An alternative to current management is restoration of the volume of blood pumped by the heart (cardiac output) using a ventricular assist device. In the acute setting this is difficult but can be done using the CorVad device which is a catheter-based, axial flow pump that pumps blood directly from the left ventricle into the circulation thereby restoring blood flow to the failing organs. The hypothesis of the current study is to reduce mortality and morbidity of patients with cardiogenic shock using the CorVad device. The study will be carried out as a randomized multicenter study where eligible patients will be randomized to receive conventional circulatory support or support with the CorVad device and inotropic support if needed. A total of 269 patients are planned",[151],"Cardiogenic Shock",[153],"Acute Myocardial Infarction","2025-03-14",{"date":156,"type":35},"2025-03-20",{"date":158,"type":20},"2025-10-01",{"date":160,"type":20},"2028-02-15",{"name":41,"class":42},""]