corheart 6 lvas long-term follow-up study

Conditions: Heart Failure

Summary: the purpose of this clinical study is to explore the long-term efficacy and safety of the corheart 6 left ventricular assist system (lvas) as a treatment for patients with advanced heart failure. the study will be a single-arm, prospective, single-center, non-blinded, and non-randomized study with a follow-up duration of five years.


Eligibility criteria:
inclusion criteria: * 1. age ≥ 18 years. * 2. the patient or legal representative is willing to participate in the study and offers informed consent. * 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 standardized treatment with oral anti-heart failure drugs. * 6. left ventricular ejection fraction (lvef) ≤ 35%, 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 (optional). exclusion criteria: * 1. etiology of heart failure due to or associated with uncorrected thyroid disease, obstructive hypertrophic cardiomyopathy, or pericardial disease. * 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 within 48 hours prior to implantation. * 11. serum creatinine (scr) \> 3.0 mg/dl within 48 hours prior to implantation or may require dialysis. * 12. presence of severe chronic obstructive pulmonary disease (copd) or restrictive lung disease or a diagnosis of primary pulmonary hypertension. * 13. presence of pulmonary embolism within 3 weeks prior to implantation. * 14. pulmonary artery systolic pressure exceeds 60mmhg, combined with at least one of the following 2 parameters demonstrating that pulmonary vascular resistance did not respond to drug therapy: * a. pulmonary vascular resistance greater than 8 wood units. * b. the transpulmonary differential pressure exceeds 20mmhg. * 15. established and untreated abdominal or thoracic aortic aneurysm \> 5cm in diameter. * 16. presence of severe peripheral vascular disease with resting pain or extremity ulceration. * 17. psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and lvas management, or brain death from various causes. * 18. history of documented disabling stroke within 90 days prior to implantation, a history of cerebrovascular disease, or the presence of uncorrected severe bilateral carotid artery stenosis. * 19. history of acute myocardial infarction within 60 days prior to implantation, judged by the investigator to have a risk of myocardial rupture or other surgical high-risk difficult-to-control bleeding, etc. * 20. expected lifetime of less than 1 year due to malignant tumor or other disease. * 21. participation in any other clinical study that may influence the results of this study. * 22. other circumstances that are unforeseen and determined by the researcher to be unsuitable.