The goal of this clinical trial is to evaluate the safety and feasibility of the CorVad Percutaneous Ventricular Assist System (Device model: CorVad RS) in patients with right heart failure who continue to experience hemodynamic instability despite best medical therapy.
despite ongoing treatment with oral heart failure medications, including continuous infusion of high-dose inotropic agents and/or vasopressors, and/or the use of more than one inotropic agent and/or vasopressor, the cardiac index (CI) remains less than 2.2 L/min/m²;
and meets any one of the following criteria: 1) CVP > 15 mmHg; or, 2) CVP/pulmonary capillary wedge pressure (PCWP) or CVP/left atrial pressure (LAP) > 0.63; or, 3) echocardiographic evidence of moderate-to-severe right ventricular dysfunction meeting one of the following criteria: right ventricular basal diameter > 42 mm, right ventricular short-axis (or mid-chamber) diameter > 35 mm, tricuspid annular systolic excursion (TAPSE) score < 14 mm, right ventricular fractional area change (FAC) < 30%, tricuspid annular systolic peak velocity (TDI S') < 9 cm/s, and right ventricular free wall longitudinal strain > -20%.
≥ 18 years old.
The patient or the patient's legal representative agrees to sign the informed consent form.
INTERMACS Stage 1 is defined as: despite the use of inotropic agents (positive inotropic drugs) and/or temporary mechanical support (such as IABP or ECMO), the patient remains hypotensive and shows signs of inadequate perfusion of vital organs (such as oliguria or worsening liver function), requiring immediate initiation of mechanical circulatory support to survive.
Severe hepatic or renal dysfunction, defined as total bilirubin ≥ 5 mg/dL or creatinine ≥ 4 mg/dL within 24 hours prior to treatment with the investigational device.
For patients who have undergone LVAD implantation, acute neurological injury occurring after implantation, including stroke, hypoxic encephalopathy, or acute neurological deficits (such as seizures or altered levels of consciousness).
Acute myocardial infarction with mechanical complications, including ventricular septal defect, cardiac rupture, or papillary muscle rupture.