Corheart 6 Left Ventricular Assist System Prospective, Multicenter, Single-arm Clinical Evaluation Trial

Corheart 6 Left Ventricular Assist System Prospective, Multicenter, Single-arm Clinical Evaluation Trial

This study is to evaluate the safety and effectiveness of the Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) used for the treatment of end-stage heart failure.

The Corheart 6 Left Ventricular Assist System (also called "the Corheart 6 LVAS", or "the Corheart 6") is developed and manufactured by Shenzhen Core Medical Technology Co., Ltd. It is indicated for providing short-term and long-term mechanical circulatory support for patients with end-stage heart failure. This prospective, multi-center, and single-arm trial evaluates the safety and effectiveness of the device in treating patients with end-stage heart failure. 50 patients from 12 investigational sites will be enrolled for Corheart 6 VAS implantation and followed for 3 months post-implantation. Following the initial 3-month follow-up, the study was extended to assess the primary endpoint of event-free survival at 24 months, with further follow-up to 5 years to evaluate long-term outcomes. The primary endpoint include the success rate of device implantation at 3 months and event-free survival at 24 months post-implantation. All adverse events will be adjudicated by an independent Clinical Events Committee (CEC).

Inclusion Criteria:

• (1) Age ≥ 18 years.
• (2) The patient or legal representative has signed the Informed Consent Form (ICF).
• (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 previous standardized oral treatment with anti-heart failure drugs (ACEI, beta-blockers, and diuretics).
• (6) Left Ventricular Ejection Fraction (LVEF) ≤ 30%, 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, and pulmonary capillary wedge pressure > 18mmHg.

Exclusion Criteria:

• (1) Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy pericardial disease, amyloidosis, or restrictive cardiomyopathy.
• (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, serum creatinine (SCr) > 3.0 mg/dL within 48 hours prior to LVAD implantation surgery or may require dialysis.
• (11) History of severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease or a diagnosis of primary pulmonary hypertension.
• (12) Pulmonary embolism and pulmonary artery systolic blood pressure exceeding 60mmHg within 3 weeks prior to enrollment combined with at least one of the following 2 parameters demonstrating that pulmonary vascular resistance did not respond to drug therapy: Pulmonary vascular resistance greater than 8 wood units; The transpulmonary differential pressure exceeds 20mmHg.
• (13) Established and untreated abdominal or thoracic aortic aneurysm > 5cm in diameter.
• (14) Presence of severe peripheral vascular disease with resting pain or extremity ulceration.
• (15) Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and Left Ventricular Assist System management, or brain death from various causes.
• (16) Expect to live less than 1 year due to malignant tumor or other diseases.
• (17) Participation in any other clinical trials that may influence the results of this study.
• (18) Other circumstances that are unforeseen and determined by the researcher to be unsuitable.