An Cohort Study of Corheart 6 Left Ventricular Assist System for the Treatment of Patients With Advanced Left Heart Failure
This study aims to evaluate the long-term effectiveness and safety of Corheart 6 left ventricular assist system as a treatment for patients with advanced left heart failure. The patients who have received the Corheart 6 treatment since October 2021, or who are planned to received it, will be enrolled until the target sample size meets statistical requirements. Data collected will include survival status, cardiac function status, quality of life, laboratory parameters and adverse events. The primary endpoint are the composite of survival at 6 months and, separately, at 24 months, defined as survival with device support, bridge to heart transplant and device explantation due to cardiac recovery, without disabling stroke (mRS \> 3) or device replacement. Data collection will adhere to the follow-up schedule specified in the protocol.
• 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.