Investigation of the BrioVAD System for the Treatment of Left Ventricular Heart Failure

Exclusion criteria

• . Patient's heart failure etiology is related to restrictive or constrictive physiology (e.g., nondilated hypertrophic cardiomyopathy, cardiac amyloidosis/senile or other infiltrative disease), complex congenital heart disease (e.g., transposition of the great vessels), uncorrected thyroid disease, and/or pericardial disease.
• . Patient had a myocardial infarction within seven days of study enrollment.
• . Patient had cardiothoracic surgery within 30 days of implant with the exception of a procedure to implant temporary MCS: Impella 5.5, Impella CP or TandemHeart.
• . Patient has physiological conditions or comorbidities which pose high surgical risk or obstacles as determined by the Investigator.
• . Patient has contraindications to warfarin anticoagulation.
• . Patient has known hypo- or hypercoagulable state \[e.g., disseminated intravascular coagulation (DIC)\], or has a positive heparin-induced thrombocytopenia (HIT) assay and positive serotonin release assay or requires use of a non-heparin alternative anticoagulation strategy for cardiopulmonary bypass in the judgement of the Investigator.
• . Patient is on durable MCS (e.g., LVAD or RVAD).
• . Planned need for durable or temporary RVAD support concomitant with LVAD implant.