Safety and Efficacy of the Extracorporeal Ventricular Assist System in Car Diogenic Shock: A Prospective, Multicenter , Single-Arm Study

Safety and Efficacy of the Extracorporeal Ventricular Assist System in Car Diogenic Shock: A Prospective, Multicenter , Single-Arm Study

Study Title: Safety and Efficacy of Extracorporeal Ventricular Assist System for Cardiogenic Shock: A Prospective, Multicenter, Single-Arm Clinical Study Objective: To evaluate the safety and efficacy of temporary mechanical circulatory support and bridge therapy with an extracorporeal ventricular assist system in patients with cardiogenic shock or weaning failure from cardiopulmonary bypass, and to comprehensively assess the device, pump head, cannulae and tubing.

Pilot Phase: Clinical validation of Class III medical device. Study Design: Prospective, multicenter, single-arm target-value design. Sample Size: 40 patients. Primary Endpoint: Success rate of mechanical circulatory support.

Secondary Endpoints:

30-day survival after transition to long-term therapy (VAD/transplant); 30-day cardiovascular mortality after device explantation; MACCE incidence; Mean support duration; Incidence of bleeding, thrombosis, hematologic events, acute renal/hepatic dysfunction, infection; Hemodynamic trends during support; Changes in SCr, BUN, ALT, TBIL at use, discharge and 30 days post-explantation vs baseline; Device satisfaction. Follow-up: Within 6 hours of initiation, during support, 24 hours, 7 days, 30 days post-explantation/transition, and at discharge.

All clinical data were collected, managed and analyzed by an independent data and statistical center and clinical monitoring unit to support safety/efficacy evaluation and market approval.

Inclusion Criteria:(1) The subject voluntarily participates in the study and has signed the informed consent form; (2) Age ≥ 18 years; (3) Subjects diagnosed with cardiogenic shock or low cardiac output syndrome meeting one of the following clinical scenarios: Unstable circulation secondary to low cardiac output after cardiac surgery, or inability to wean from cardiopulmonary bypass during surgery; Acute decompensation of heart failure (including ischemic cardiomyopathy, dilated cardiomyopathy, etc.) with persistent hemodynamic instability despite conventional pharmacotherapy and IABP support; Hemodynamic instability in patients with end-stage heart failure prior to heart transplantation or transition to other long-term therapeutic strategies.

(4) Cardiogenic shock shall meet the following criteria:

Signs of inadequate perfusion (at least one item):

① Altered mental status unexplainable by other causes: agitation in the early stage, lethargy and stupor in the late stage;

• Cool, clammy and mottled skin of extremities; ③ Oliguria (<30 mL/h or 0.5 mL/kg/h).

Hypotension with adequate intravascular volume (at least one item):

• Systolic blood pressure ≤90 mmHg or mean arterial pressure ≤60 mmHg lasting more than 30 minutes; ② Requirement for vasoactive agents or inotropic agents to maintain systolic blood pressure ≥90 mmHg; ③ Systolic blood pressure ≥90 mmHg after excluding trauma, intoxication, hypoxia and other factors, accompanied by obvious manifestations of hypoperfusion.

Laboratory or hemodynamic findings (at least one item):

• Hemodynamics: Cardiac Index (CI) ≤2.2 L/min·m², Pulmonary Capillary Wedge Pressure (PCWP) ≥15 mmHg;

  • Laboratory test: Lactate ≥2 mmol/L; ③ Serum creatinine increased to 1.5 times the baseline value, or glomerular filtration rate decreased by >50%; ④ ALT elevated to 3 times the upper limit of normal. (5) Authorized clinicians confirm that all feasible measures have been implemented to correct abnormalities of arterial blood gas, electrolyte disorders, hypovolemia, hypervolemia, bradycardia, arrhythmia and incomplete rewarming.

Exclusion Criteria:

• (1) Patients who fail to comply with medical treatment protocols; (2) Patients with established irreversible central nervous system injury; (3) Patients intolerant to anticoagulants (such as heparin or equivalent alternatives); (4) Patients with severe infection, malignant tumor, or end-stage multiple organ failure; (5) Patients with implanted mechanical heart valves, moderate to severe aortic regurgitation, or unrepaired structural cardiac lesions (e.g., ventricular septal rupture); (6) Patients with severe peripheral vascular disease or irreversible neurological/neuromuscular disorders; (7) Patients with pulmonary embolism, pulmonary infarction, or uncorrectable pulmonary hypertension; (8) Patients with psychiatric disorders requiring long-term standardized treatment or relevant medical history, drug abusers, and patients positive for HIV or syphilis; (9) Patients with a history of stroke or transient ischemic attack (TIA) within the past 3 months; (10) Patients with active bleeding or disorders of coagulation; (11) Female patients during pregnancy; (12) Patients who have participated in another clinical trial within 1 month, or are currently participating in another clinical trial that has not reached its endpoint; (13) Patients with other conditions deemed ineligible for this trial by the investigator.