Corheart 6: Long-term Cohort Study

Prior treatment

• Based on the investigator's judgment, presence of technical difficulties that would lead to unacceptable surgical risk.
• Presence of pulmonary embolism within 3 weeks prior to enrollment.

Other illness

• Heart failure caused by unresolved thyroid disease, hypertrophic obstructive cardiomyopathy, pericardial disease, or related conditions.
• Subject is intolerant to anticoagulation or antiplatelet therapy, or cannot receive other perioperative and postoperative treatments deemed necessary by the investigator based on the patient's health condition.
• Presence of moderate to severe aortic regurgitation or a history of mechanical aortic valve implantation but refuse or is unable to converted to a bioprosthesis or oversewn at the time of LVAD implant.
• History of any organ transplant.
• History of severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, or diagnosed primary pulmonary hypertension.
• History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) \> 5 cm in diameter.
• Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration.
• Mental illness/disorder, irreversible cognitive dysfunction, or psychosocial issues that may prevent the patient from adhering to the study protocol and the management of the implanted left ventricular assist device, or any condition leading to brain death.
• Presence cancer or other diseases that could limit survival to less than 24 months.

Lab values

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

Other

• Require biventricular assist device support.
• Pregnancy.
• Presence of unresolved thrombocytopenia or severe coagulopathy, such as disseminated intravascular coagulation (DIC).
• Pulmonary artery systolic pressure greater than 60 mmHg and meet at least one of the criteria which prove the pulmonary vessels is unresponsive to pharmacologic intervention: a. most recent pulmonary vascular resistance (PVR) ≥ 8 Woods; b. transpulmonary pressure \> 20mmHg.
• Participation in any other clinical investigation that is likely to confound study results or affect the study.
• Unforeseen circumstances that the investigator determines to be unsuitable for the study.

• 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 of contraception for the duration of the study.
• Diagnosis of NYHA Class IV heart failure, refractory to optimal guideline-directed medical therapy (GDMT) (e.g., ACE inhibitors, β-blockers, and diuretics).
• Left Ventricular Ejection Fraction (LVEF) \< 30%, with at least one of the following conditions:
  • Dependence on an intra-aortic balloon pump (IABP), extracorporeal membrane oxygenation (ECMO), or other short-term mechanical circulatory support with an inability to be weaned.
  • Dependence on continuous intravenous inotropic support.
  • Meets the diagnostic criteria for cardiogenic shock: blood pressure \< 90/60 mmHg, cardiac index \< 2.0, pulmonary capillary wedge pressure \> 18 mmHg
• Subject or their legally authorized representative agrees to participate in the study and signs the informed consent form.