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