Corheart 6: Long-term Cohort Study

Inclusion Criteria:

• Age ≥ 18 years.

• Subject who have undergone Corheart 6 implantation on or after October 1, 2021.

• Body Surface Area (BSA) > 1.0 m2.

• Women of childbearing potential must use agree to use a effective method ofcontraception for the duration of the study.

• Diagnosis of NYHA Class IV heart failure, refractory to optimal guideline-directedmedical therapy (GDMT) (e.g., ACE inhibitors, β-blockers, and diuretics).

• Left Ventricular Ejection Fraction (LVEF) < 30%, with at least one of the followingconditions:

1. Dependence on an intra-aortic balloon pump (IABP), extracorporeal membraneoxygenation (ECMO), or other short-term mechanical circulatory support with aninability to be weaned.

2. Dependence on continuous intravenous inotropic support.

3. Meets the diagnostic criteria for cardiogenic shock: blood pressure < 90/60mmHg, cardiac index < 2.0, pulmonary capillary wedge pressure > 18 mmHg

• Subject or their legally authorized representative agrees to participate in thestudy and signs the informed consent form.

Exclusion Criteria:

• Heart failure caused by unresolved thyroid disease, hypertrophic obstructivecardiomyopathy, pericardial disease, or related conditions.

• Presence of active, uncontrolled infection confirmed through clinical symptoms andlaboratory tests.

• Based on the investigator's judgment, presence of technical difficulties that wouldlead to unacceptable surgical risk.

• Subject is intolerant to anticoagulation or antiplatelet therapy, or cannot receiveother perioperative and postoperative treatments deemed necessary by theinvestigator based on the patient's health condition.

• Require biventricular assist device support.

• Pregnancy.

• Presence of moderate to severe aortic regurgitation or a history of mechanicalaortic valve implantation but refuse or is unable to converted to a bioprosthesis oroversewn at the time of LVAD implant.

• History of any organ transplant.

• Presence of unresolved thrombocytopenia or severe coagulopathy, such as disseminatedintravascular coagulation (DIC).

• Preoperative total bilirubin (TBIL) > 3.0 mg/dL, serum creatinine (SCr) > 3.0 mg/dL,or requirement for dialysis within 48 hours prior to surgery.

• History of severe chronic obstructive pulmonary disease (COPD), restrictive lungdisease, or diagnosed primary pulmonary hypertension.

• Presence of pulmonary embolism within 3 weeks prior to enrollment.

• Pulmonary artery systolic pressure greater than 60 mmHg and meet at least one of thecriteria which prove the pulmonary vessels is unresponsive to pharmacologicintervention: a. most recent pulmonary vascular resistance (PVR) ≥ 8 Woods; b.transpulmonary pressure > 20mmHg.

• History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aorticaneurysm (TAA) > 5 cm in diameter.

• Significant peripheral vascular disease (PVD) accompanied by rest pain or extremityulceration.

• Mental illness/disorder, irreversible cognitive dysfunction, or psychosocial issuesthat may prevent the patient from adhering to the study protocol and the managementof the implanted left ventricular assist device, or any condition leading to braindeath.

• Presence cancer or other diseases that could limit survival to less than 24 months.

• Participation in any other clinical investigation that is likely to confound studyresults or affect the study.

• Unforeseen circumstances that the investigator determines to be unsuitable for thestudy.