[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100506562":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":165,"collaborators":20,"id":167,"slug":168,"hasResults":169,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":20,"eligibilityCriteria":173,"healthyVolunteers":169,"sex":174,"minAge":175,"maxAge":176,"enrollmentInfo":177,"targetDuration":20,"studyType":180,"phases":181,"briefSummary":183,"conditions":184,"keywords":186,"overallStatus":50,"whyStopped":20,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":199},{"fullName":5,"class":6},"Shenzhen Core Medical Technology CO.,LTD.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Corheart 6 LVAS","EXPERIMENTAL","The Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) to be used on patients with advanced left ventricular heart failure.",[13],"Device: Corheart 6 Left Ventricular Assist System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Corheart 6 Left Ventricular Assist System","Implantation of left ventricular assist device for mechanical circulatory support",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Evgenij V Potapov","German Heart Institute","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Xiaoli Shi","CONTACT","+86 13418601356","shixiaoli@coretechmed.com",[33,48,60,73,86,97,108,119,130,141,154],{"facility":34,"status":35,"city":36,"state":20,"zip":20,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Universitätsklinikum Graz","NOT_YET_RECRUITING","Graz","Austria","AT",{"type":40,"coordinates":41},"Point",[42,43],15.44197,47.06733,{"lat":43,"lon":42},[46],{"name":47,"role":29,"phone":20,"phoneExt":20,"email":20},"Ao.Univ.-Prof.i.R. Dr.med.univ. Heinrich Mächler",{"facility":49,"status":50,"city":51,"state":20,"zip":20,"country":37,"countryCode":38,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"Universitätskliniken der MedUni Wien","RECRUITING","Vienna",{"type":40,"coordinates":53},[54,55],16.37208,48.20849,{"lat":55,"lon":54},[58],{"name":59,"role":29,"phone":20,"phoneExt":20,"email":20},"Univ.-Prof. Priv.-Doz. Dr. Daniel Zimpfer",{"facility":61,"status":50,"city":62,"state":20,"zip":20,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Herz-und Diabeteszentrum Nordrhein-Westfalen","Bad Oeynhausen","Germany","DE",{"type":40,"coordinates":66},[67,68],8.80365,52.20699,{"lat":68,"lon":67},[71],{"name":72,"role":29,"phone":20,"phoneExt":20,"email":20},"Dr. med. Michiel Morshuis",{"facility":74,"status":50,"city":75,"state":20,"zip":20,"country":63,"countryCode":64,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Deutsches Herzzentrum der Charité","Berlin",{"type":40,"coordinates":77},[78,79],13.41053,52.52437,{"lat":79,"lon":78},[82],{"name":83,"role":29,"phone":84,"phoneExt":20,"email":85},"Prof. Dr. med. Evgenij Potapov","+49 30 4593-2000","evgenij.potapov@dhzc-charite.de",{"facility":87,"status":35,"city":88,"state":20,"zip":20,"country":63,"countryCode":64,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Klinikum Links der Weser","Bremen",{"type":40,"coordinates":90},[91,92],8.80717,53.07582,{"lat":92,"lon":91},[95],{"name":96,"role":29,"phone":20,"phoneExt":20,"email":20},"Prof. Dr. med. 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Anna Meyer",{"facility":120,"status":50,"city":121,"state":20,"zip":20,"country":63,"countryCode":64,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Herzzentrum Leipzig","Leipzig",{"type":40,"coordinates":123},[124,125],12.37129,51.33962,{"lat":125,"lon":124},[128],{"name":129,"role":29,"phone":20,"phoneExt":20,"email":20},"Priv.-Doz. Dr. med. Alexey Dashkevich",{"facility":131,"status":35,"city":132,"state":20,"zip":20,"country":63,"countryCode":64,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Universitätsklinikum Würzburg","Würzburg",{"type":40,"coordinates":134},[135,136],9.95121,49.79391,{"lat":136,"lon":135},[139],{"name":140,"role":29,"phone":20,"phoneExt":20,"email":20},"Univ.-Prof. Dr. med. Gloria Färber",{"facility":142,"status":35,"city":143,"state":20,"zip":20,"country":144,"countryCode":145,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"IRCCS Ospedale San Raffaele","Milan","Italy","IT",{"type":40,"coordinates":147},[148,149],12.59836,42.78235,{"lat":149,"lon":148},[152],{"name":153,"role":29,"phone":20,"phoneExt":20,"email":20},"Prof. De Bonis Michele",{"facility":155,"status":35,"city":156,"state":20,"zip":20,"country":144,"countryCode":145,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino","Torino",{"type":40,"coordinates":158},[159,160],11.99138,44.88856,{"lat":160,"lon":159},[163],{"name":164,"role":29,"phone":20,"phoneExt":20,"email":20},"Prof. Antonio Loforte",{"type":166,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100506562","corheart-6-lvas-study-100506562",false,"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.","ALL","18 Years","75 Years",{"count":178,"type":179},53,"ESTIMATED","INTERVENTIONAL",[182],"NA","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.",[185],"Refractory Heart Failure",[187,188,189],"Advanced Heart Failure","Left Ventricular Assist System","Mechanical Circulatory Support","2026-01-06",{"date":192,"type":193},"2026-01-08","ACTUAL",{"date":195,"type":193},"2024-05-14",{"date":197,"type":179},"2031-06-30",{"name":5,"class":6},11]