European Investigation of the BrioVAD Left Ventricular Assist System for the Treatment of Refractory Left Ventricular Heart Failure
This clinical investigation evaluates the safety and clinical performance of the BrioVAD Left Ventricular Assist System in patients with advanced, refractory left ventricular heart failure who require mechanical circulatory support.
• Patient is ≥ 18 years of age.
• Patient has a body surface area (BSA) ≥ 1.2 m2.
• Patient is classified as NYHA Class IV with advanced heart failure refractory to advanced heart failure management or NYHA Class III with dyspnea upon mild physical activity.
• Patient has a left ventricular ejection fraction (LVEF) ≤ 25% or LVEF \< 30% on inotropes or intra-aortic balloon pump (IABP).
• Patient is inotrope dependent, OR has a cardiac index (CI) ≤ 2.2 liters/min/m2, while not on inotropes, and also meets one of the following criteria:
‣ Is on optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and is failing to respond or is not able to tolerate OMM; or
⁃ Has advanced heart failure for at least 14 days and is dependent on an IABP for at least seven days.
• Patient has provided voluntary and informed consent.
• Females of childbearing age agree to use adequate contraception and have a negative pregnancy test.