HeartMate PHP™ CE Mark Clinical Investigation Plan

Inclusion Criteria: * At least 18 years of age. * Patient presents with a non-emergent need for complex PCI with: 1. an ejection fraction of ≤35% requiring hemodynamic support during the procedure, AND 2. the heart team has determined that the patient is not an optimal surgical candidate, OR the patient elects not to undergo surgery * Written, signed, and dated informed consent Exclusion Criteria: * Emergent PCI * ST elevation myocardial infarction within 7 days of procedure * Cardiac arrest within 7 days of procedure requiring CPR or defibrillation * Hemodynamic support with the HeartMate PHP post-PCI is anticipated * Cardiogenic shock (SBP \<90 mmHg for \>1 hour with either cool clammy skin OR oliguria OR altered sensorium OR cardiac index \<2.2 L/min/m2) * Mural thrombus in the left ventricle * History of aortic valve replacement * Documented presence of aortic stenosis (orifice area of 1.5cm2 or less) * Moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as 2 or higher) * Severe peripheral vascular disease * Abnormalities of the aorta that would preclude surgery, including aneurysms and significant tortuosity or calcifications * Planned use of rotablator or atherectomy during the procedure * Serum creatinine \> 3.5mg/dL within 7 days of procedure * Liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ 3x ULN or INR (Internationalized Normalized Ratio) ≥2 * Uncorrectable abnormal coagulation parameters * Active systemic infection requiring treatment with antibiotics * Clinically relevant stroke or TIA within 3 months of procedure. Patients with suspected stroke or TIA within 3 months of procedure must have documented absence of neurological infarction * Uncontrollable allergy or intolerance to heparin, aspirin, clopidogrel, ionic and nonionic contrast media, or any other potentially required anticoagulants or antiplatelet therapy drugs * History of heparin induced thrombocytopenia * Patient is pregnant or planning to become pregnant during the study period * Participation in another clinical study of an investigational drug or device that has not met its primary endpoint-