corheart 6 left ventricular assist system prospective, multicenter, single-arm clinical evaluation trial

Conditions: End-stage Heart Failure

Summary: this study is to evaluate the safety and effectiveness of the corheart 6 left ventricular assist system (corheart 6 lvas) used for the treatment of end-stage heart failure.

the corheart 6 left ventricular assist system (also called "the corheart 6 lvas", or "the corheart 6") is developed and manufactured by shenzhen core medical technology co., ltd. it is indicated for providing short-term and long-term mechanical circulatory support for patients with end-stage heart failure. this prospective, multi-center, and single-arm trial evaluates the safety and effectiveness of the device in treating patients with end-stage heart failure. 50 patients from 12 investigational sites will be enrolled for corheart 6 vas implantation and followed for 3 months post-implantation. the primary study endpoint is the success rate of device implantation at 3 months post-implantation. all adverse events will be adjudicated by an independent clinical events committee (cec).

Eligibility criteria:
inclusion criteria: * (1) age ≥ 18 years. * (2) the patient or legal representative has signed the informed consent form (icf). * (3) body surface area (bsa) ≥ 1.0 m\^2. * (4) females of childbearing age must agree to use adequate contraception. * (5) patients with nyha class iv heart failure symptoms who have failed to be reversed by previous standardized oral treatment with anti-heart failure drugs (acei, beta-blockers, and diuretics). * (6) left ventricular ejection fraction (lvef) ≤ 30%, and at least one of the following conditions occurs: * a. fail to be reversed by or be weaned from intra-aortic balloon pump (iabp), extracorporeal membrane oxygenator (ecmo), or other short-term mechanical circulatory support; * b. rely on continuous intravenous administration of one or more vasoactive or inotropic drugs; * c. meeting the diagnostic criteria of cardiogenic shock: blood pressure \ 18mmhg. exclusion criteria: * (1) etiology of hf due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy pericardial disease, amyloidosis, or restrictive cardiomyopathy. * (2) presence of an active, uncontrolled infection confirmed by a combination of clinical symptoms and laboratory tests. * (3) technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator. * (4) intolerance to anticoagulant or antiplatelet therapies or any other peri/postoperative therapy the investigator will require based on the patient's health status. * (5) patients require bi-ventricular assist device support. * (6) pregnancy. * (7) presence of moderate to severe aortic insufficiency or a history of the mechanical aortic valve that will not be converted to a bioprosthesis or oversewn at the time of implantation. * (8) history of any organ transplantation. * (9) presence of uncorrected thrombocytopenia or severe coagulopathy, such as diffuse intravascular coagulation. * (10) tbil (total bilirubin) \> 3.0 mg/dl, serum creatinine (scr) \> 3.0 mg/dl within 48 hours prior to lvad implantation surgery or may require dialysis. * (11) history of severe chronic obstructive pulmonary disease (copd) or restrictive lung disease or a diagnosis of primary pulmonary hypertension. * (12) pulmonary embolism and pulmonary artery systolic blood pressure exceeding 60mmhg within 3 weeks prior to enrollment combined with at least one of the following 2 parameters demonstrating that pulmonary vascular resistance did not respond to drug therapy: pulmonary vascular resistance greater than 8 wood units; the transpulmonary differential pressure exceeds 20mmhg. * (13) established and untreated abdominal or thoracic aortic aneurysm \> 5cm in diameter. * (14) presence of severe peripheral vascular disease with resting pain or extremity ulceration. * (15) psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and left ventricular assist system management, or brain death from various causes. * (16) expect to live less than 1 year due to malignant tumor or other diseases. * (17) participation in any other clinical trials that may influence the results of this study. * (18) other circumstances that are unforeseen and determined by the researcher to be unsuitable.

Keywords: end-stage heart failure ventricular assist system mechanical circulatory support