Corheart 6 LVAS Long-term Follow-up Study

Prior treatment

• 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.
• 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:
• 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.

Other illness

• 1\. Etiology of heart failure due to or associated with uncorrected thyroid disease, obstructive hypertrophic cardiomyopathy, or pericardial disease.
• 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.
• 12\. Presence of severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease or a diagnosis of primary pulmonary hypertension.
• 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.
• 20\. Expected lifetime of less than 1 year due to malignant tumor or other disease.

Lab values

• 2\. Presence of an active, uncontrolled infection confirmed by a combination of clinical symptoms and laboratory tests.
• 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.

Other

• 5\. Patients require bi-ventricular assist device support.
• 6\. Pregnancy.
• 9\. Presence of uncorrected thrombocytopenia or severe coagulopathy, such as diffuse intravascular coagulation.
• 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.
• 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.

• 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 \< 90/60mmHg, cardiac index \< 2.0 L/min/m\^2 (optional), and pulmonary capillary wedge pressure \> 18mmHg (optional).