The objective of this clinical investigation is to evaluate the safety and efficacy of the DuoCor 2 Ventricular Assist System (DuoCor 2 VAS) in subjects with advanced biventricular heart failure requiring circulatory support.
Each subject receiving the DuoCor 2 VAS will be evaluated at 6 months (180 days) for primary and secondary endpoints with further follow-up assessments up to 2 years.
1.18 years ≤ Age ≤ 75 years
2.INTERMACS Class 1-2
3.Patient is inotrope dependent, OR has a Cardiac Index (CI) < 2.2 L/min/m2, while not on inotropes
Unable to exercise
1.Known intolerance to anticoagulant or antiplatelet therapies.
2.Etiology of heart failure due to restrictive or constrictive physiology (e.g., hypertrophic cardiomyopathy, cardiac amyloidosis /senile or other infiltrative heart disease)
3.Coagulopathy defined by platelets < 100*10^9/L or INR ≥ 1.5 not due to anticoagulant therapy.
4. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator.