[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100506562":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":162,"collaborators":20,"id":164,"slug":20,"hasResults":165,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":20,"eligibilityCriteria":169,"healthyVolunteers":165,"sex":170,"minAge":171,"maxAge":172,"enrollmentInfo":173,"targetDuration":20,"studyType":176,"phases":177,"briefSummary":179,"conditions":180,"keywords":182,"overallStatus":49,"whyStopped":20,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":195},{"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",[33,47,59,71,84,95,106,117,128,139,151],{"facility":34,"status":35,"city":36,"state":20,"zip":20,"country":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Universitätsklinikum Graz","NOT_YET_RECRUITING","Graz","Austria",{"type":39,"coordinates":40},"Point",[41,42],15.44197,47.06733,{"lat":42,"lon":41},[45],{"name":46,"role":29,"phone":20,"phoneExt":20,"email":20},"Ao.Univ.-Prof.i.R. Dr.med.univ. Heinrich Mächler",{"facility":48,"status":49,"city":50,"state":20,"zip":20,"country":37,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"Universitätskliniken der MedUni Wien","RECRUITING","Vienna",{"type":39,"coordinates":52},[53,54],16.37208,48.20849,{"lat":54,"lon":53},[57],{"name":58,"role":29,"phone":20,"phoneExt":20,"email":20},"Univ.-Prof. Priv.-Doz. Dr. Daniel Zimpfer",{"facility":60,"status":49,"city":61,"state":20,"zip":20,"country":62,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Herz-und Diabeteszentrum Nordrhein-Westfalen","Bad Oeynhausen","Germany",{"type":39,"coordinates":64},[65,66],8.80365,52.20699,{"lat":66,"lon":65},[69],{"name":70,"role":29,"phone":20,"phoneExt":20,"email":20},"Dr. med. Michiel Morshuis",{"facility":72,"status":49,"city":73,"state":20,"zip":20,"country":62,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Deutsches Herzzentrum der Charité","Berlin",{"type":39,"coordinates":75},[76,77],13.41053,52.52437,{"lat":77,"lon":76},[80],{"name":81,"role":29,"phone":82,"phoneExt":20,"email":83},"Prof. Dr. med. Evgenij Potapov","+49 30 4593-2000","evgenij.potapov@dhzc-charite.de",{"facility":85,"status":35,"city":86,"state":20,"zip":20,"country":62,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Klinikum Links der Weser","Bremen",{"type":39,"coordinates":88},[89,90],8.80717,53.07582,{"lat":90,"lon":89},[93],{"name":94,"role":29,"phone":20,"phoneExt":20,"email":20},"Prof. Dr. med. Jens Garbade",{"facility":96,"status":49,"city":97,"state":20,"zip":20,"country":62,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Universitätsklinikum Hamburg","Hamburg",{"type":39,"coordinates":99},[100,101],9.99302,53.55073,{"lat":101,"lon":100},[104],{"name":105,"role":29,"phone":20,"phoneExt":20,"email":20},"Priv.-Doz. Dr. med. Alexander Bernhardt",{"facility":107,"status":49,"city":108,"state":20,"zip":20,"country":62,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Universitätsklinikums Heidelberg","Heidelberg",{"type":39,"coordinates":110},[111,112],8.69079,49.40768,{"lat":112,"lon":111},[115],{"name":116,"role":29,"phone":20,"phoneExt":20,"email":20},"Prof. Dr. med. Anna Meyer",{"facility":118,"status":49,"city":119,"state":20,"zip":20,"country":62,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Herzzentrum Leipzig","Leipzig",{"type":39,"coordinates":121},[122,123],12.37129,51.33962,{"lat":123,"lon":122},[126],{"name":127,"role":29,"phone":20,"phoneExt":20,"email":20},"Priv.-Doz. Dr. med. Alexey Dashkevich",{"facility":129,"status":35,"city":130,"state":20,"zip":20,"country":62,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Universitätsklinikum Würzburg","Würzburg",{"type":39,"coordinates":132},[133,134],9.95121,49.79391,{"lat":134,"lon":133},[137],{"name":138,"role":29,"phone":20,"phoneExt":20,"email":20},"Univ.-Prof. Dr. med. Gloria Färber",{"facility":140,"status":35,"city":141,"state":20,"zip":20,"country":142,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"IRCCS Ospedale San Raffaele","Milan","Italy",{"type":39,"coordinates":144},[145,146],12.59836,42.78235,{"lat":146,"lon":145},[149],{"name":150,"role":29,"phone":20,"phoneExt":20,"email":20},"Prof. De Bonis Michele",{"facility":152,"status":35,"city":153,"state":20,"zip":20,"country":142,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino","Torino",{"type":39,"coordinates":155},[156,157],11.99138,44.88856,{"lat":157,"lon":156},[160],{"name":161,"role":29,"phone":20,"phoneExt":20,"email":20},"Prof. Antonio Loforte",{"type":163,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","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":174,"type":175},53,"ESTIMATED","INTERVENTIONAL",[178],"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.",[181],"Refractory Heart Failure",[183,184,185],"Advanced Heart Failure","Left Ventricular Assist System","Mechanical Circulatory Support","2026-01-06",{"date":188,"type":189},"2026-01-08","ACTUAL",{"date":191,"type":189},"2024-05-14",{"date":193,"type":175},"2031-06-30",{"name":5,"class":6},11]