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.
Single group
CorVad Percutaneous Ventricular Assist System
DeviceThe CorVad Percutaneous Ventricular Assist System (Device model: CorVad RS) is used to provide hemodynamic support by shareing some or all the workload of the right ventricles during the support period.
The survival rate
Feasibility endpoint at 30 days after device explant or at hospital discharge (whichever is longer) or to the induction of anesthesia to a longer-term therapy, which includes a heart transplant or an implant of a surgical right ventricular assist device (RVAD).
Death
All-cause death
Major Bleeding
MCS-ARC 3, 4, 5 type bleeding
Major hemolysis
Two plasma-free Hgb values \> 40mg/dl with the 2 readings taken within a single 48-hour period. If plasma-free Hgb not available, hemolysis will be defined by the combination of clinical signs (see below) and laboratory testing including increased LDH, increased bilirubin and decreased hemoglobin (all 3 required). It requires the presence of one or more of the following conditions: 1. Hemoglobinuria 2. Anemia 3. Hyperbilirubinemia 4. Pumpmalfunctionand/orabnormalpumpparameters
Pulmonary embolism
New presence of blockage in the pulmonary artery caused by a clot and documented clinically and confirmed by computed tomography scan, magnetic resonance imaging, or pulmonary angiography.
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