Sistema de asistencia ventricular CorVad para el shock cardiogénico en la miocardiopatía

Fecha de inicio: 12 de octubre de 2024

Inclusion Criteria: * 1\. Age of subjects must be between 18 and 80 years old (inclusive). * 2\. Presence of heart failure or cardiac dysfunction caused by cardiomyopathy. * 3\. Occurrence of cardiogenic shock under adequate blood volume, which must meet one of the following conditions: 1. Rapidly Worsening Cardiogenic Shock: Progressive hemodynamic instability requiring repeated administration of vasopressors to maintain mean arterial pressure \>50 mmHg, and left ventricular systolic function is impaired (LVEF \<35% or LVEF 35-55% with significant mitral regurgitation). 2. Severe Cardiogenic Shock: Cardiac index (CI) \< 2.2 L/min/m² + norepinephrine dose \> 0.1 µg/kg/min + dopamine or dobutamine dose \> 10 µg/kg/min; systolic blood pressure \< 90 mmHg + norepinephrine dose \> 0.2 µg/kg/min + dopamine or dobutamine dose \> 10 µg/kg/min + LVEF \< 35% or LVEF 35-55% with significant mitral regurgitation. * 4\. Two consecutive blood lactate measurements ≥ 3.0 mmol/L (with at least a 30-minute interval). * 5\. The subject or their guardian must be able to understand the purpose of the trial, sign the informed consent form, demonstrate good compliance after discharge, and be willing to complete clinical follow-up. Exclusion Criteria: * 1\. Continuous cardiopulmonary resuscitation (CPR) cannot restore circulation. * 2\. CorVad cannot be implanted or applied (including but not limited to left ventricular mural thrombus, presence of artificial aortic valve or cardiac contraction devices, moderate to severe aortic stenosis, moderate to severe aortic regurgitation, aortic dissection, aneurysm, or severe abnormalities of the ascending aorta and/or aortic arch, blood cell fragility, or hemolytic blood disorders). * 3\. Inability to use heparin for anticoagulation therapy. * 4\. Shock caused by other reasons (e.g., myocardial infarction, arrhythmia, hypovolemia, septic shock, etc.). * 5\. Presence of unrepaired cardiac structural damage (e.g., chordal rupture, ventricular septal perforation, free wall rupture, etc.). * 6\. Severe right heart failure. * 7\. Pregnant or breastfeeding women. * 8\. Currently participating in another clinical trial of a drug or device that has not yet reached its primary endpoint. * 9\. Any other circumstances deemed inappropriate for inclusion in this study by the investigator.