The Prospective, Multicenter, Randomized Controlled Trial of the VentriCure Interventional Left Ventricular Assist System

Inclusion criteria

• Patient age ≥18 years old;
• As assessed by the cardiac team the patient needs coronary revascularization, but CABG (Coronary Artery Bypass Grafting) is of high risk, or the patient refuses to undergo CABG;
• The patient is meeting one of the following:

(1) Coronary Artery Disease and left ventricular ejection fraction ≤35%; (2) Coronary Artery Disease and left ventricular ejection fraction ≤40% and severe heart failure; 4. PCI was required for imaging diagnosis; 5. Patient willing and able to comply with protocol requirements and accept clinical follow-up; able to understand study purpose and sign informed consent.

Exclusion criteria

• Cardiac arrest within 24 hours;
• The implantation of an interventional left ventricular assist system was either contraindicated or not feasible;
• ST-segment elevation myocardial infarction (STEMI) within 24 hours;
• Chronic Kidney Disease;
• Severe right heart failure or severe tricuspid regurgitation;
• Presence of abnormal coagulation parameters (platelet count ≤75,000/mm^3, INR≥2.0, or fibrinogen ≤1.50g/L);
• Moderate or higher anemia;
• History of stroke or transient ischemic attack (TIA) within one month;
• Allergy or intolerance to anticoagulants or contrast agent;
• Active internal bleeding within a month;
• Presence of uncontrolled active infection;
• Pregnant or lactating women;
• Patients are participating in other clinical trials;
• Other circumstances that are determined by the investigator to be unsuitable for the study.