[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645502":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":19,"responsibleParty":26,"collaborators":19,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":19,"eligibilityCriteria":34,"healthyVolunteers":30,"sex":35,"minAge":36,"maxAge":19,"enrollmentInfo":37,"targetDuration":19,"studyType":40,"phases":41,"briefSummary":43,"conditions":44,"keywords":46,"overallStatus":51,"whyStopped":19,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":19},{"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 LVAS",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","Implantation of left ventricular assist device for mechanical circulatory support",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Leon Lai","CONTACT","+86 755 23225941","laishengfeng@coretechmed.com",{"type":27,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100645502","corheart-6-lvas-clinical-investigation-100645502",false,"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.","ALL","18 Years",{"count":38,"type":39},100,"ESTIMATED","INTERVENTIONAL",[42],"NA","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.",[45],"Advanced Left Ventricular Heart Failure",[47,48,49,50],"advanced left ventricular heart failure","Advanced Heart Failure","Left Ventricular Assist System","Mechanical Circulatory Support","NOT_YET_RECRUITING","2026-07-15",{"date":54,"type":55},"2026-07-17","ACTUAL",{"date":57,"type":39},"2027-01-31",{"date":59,"type":39},"2034-01-31",{"name":5,"class":6}]