C-Pulse IDE Feasibility Study- A Heart Assist System

Inclusion Criteria:

Patient has ACC/AHA Stage C heart failure and remains in NYHA Class III - ambulatory Class IV despite optimal medical therapy.
ACE inhibitor or ARB (Angiotensin Receptor Blocks) at least 30 days preceding implant or nitrate/hydralazine at the investigators discretion
Beta-blocker for at least 90 days and stable for 30 days preceding implant
Patient has left ventricular ejection fraction (LVEF) ≤ 35%
Patient has had Cardiac Resynchronization Therapy (CRT) for at least 90 days prior to enrollment or is not indicated for a CRT device
Patient has had an implanted cardio-defibrillator (ICD) at least 30 days prior to enrollment or is not indicated for ICD implantation.
Patient is at least 18 years of age and not older than 75 years
Patient six minute hall walk assessment between 100-350 meters
Patient understands the nature of the procedure, is willing to comply with associated follow-up evaluations, and provide written informed consent prior to the procedure

Exclusion Criteria:

Patient has any evidence of:

Ascending aortic calcification on posterior-anterior or lateral chest x-ray at initial screening OR
Atherosclerotic ascending aortic disease, specifically intimal thickening greater than 3mm or mobile atheroma (moderate) or mural calcification (severe) as detected by CT scan or echocardiography (Echo)
Patient has ascending aorto-coronary artery bypass grafts, history of aortic dissection, Marfans disease or other connective tissue disorder or has had an aortic root replacement
Patient aorta not conforming to specified dimensional constraints defined by CT scan, most specifically mid ascending aortic outside diameter less than 29mm or greater than 40mm
Patient has severe mitral valve incompetence, grade 4+
Patient has moderate to severe aortic valve incompetence, grade 2-4+
Patient has systolic blood pressure less than 90 or greater than 140 mmHg
Patient has a Serum Sodium less than 130 mEq/L
Patient has a Estimated Glomerular Filtration Rate (GFR) less than 40 ml/min/1.73m2
Patient has any two of three of Bilirubin, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) greater than three times upper limit of normal
Patient has a serum Albumin less than 3.0 g/dL
Patient has Body Mass Index (BMI) less than 18 or greater than 40 kg/m2
Men with Peak Oxygen Uptake (VO2) of greater than 18 ml/kg/min or less than 10 ml/kg/min OR -Women with Peak VO2 of greater than 16 ml/kg/min or less than 9 ml/kg/min
Patient has any active infection
Patient has had a myocardial infarction (MI), stroke, transient ischemic attack (TIA), cardiac or other major surgery, in the 90 days prior to enrollment
Patient has severe Chronic Obstructive Pulmonary Disease (COPD) as evidenced by Forces Expiratory Volume (FEV1) less than or equal to 0.9 L/min
Patient requires a concomitant surgical procedure [i.e. coronary artery bypass graft (CABG), Valve repair]
Patient is supported with a left ventricular assist device or IABP
Severe Right Heart Dysfunction with systemic venous congestion evidenced by clinical signs/symptoms such as Central Venous Pressure (CVP) ≥ 20 mmHg, Cardiac Index (CI) < 2.0 l/min./m2, elevated liver function tests beyond three time the upper limit of normal and presence of ascites
Patient has reversible causes of heart failure that may be remedied by conventional surgery or other intervention
Patient is pregnant; Note: Negative pregnancy test required in all women of child bearing potential
Patient has any other condition that, in the opinion of the investigators, would disqualify the patient for inclusion in the study, limits survival to less than one year, or not permit valid consideration
Patient is currently enrolled or has participated in the last 30 days in another therapeutic or interventional clinical study that is likely to confound study results
Patient has symptomatic Carotid artery disease or asymptomatic disease with a stenosis greater than 70%.