Treating Congestive Heart Failure Using a Device to Remove Cholesterol

Inclusion Criteria:

Male or Female, between the age of 18 and 85 years old. If female, must guarantee that pregnancy will not occur for duration of study
Presence of Left ventricular systolic dysfunction due to ischemic or non-ischemic cardiomyopathy and have symptoms of New York Heart Association Class III chronic Heart failure (CHF)
Left ventricular ejection fraction (LVEF) ≤ 35% as measured by radionuclide angiography
Subject must be on optimal conventional heart failure therapy including Beta-blocker in target or maximally tolerated doses for at least 3 months prior to entry into the study, and/or an angiotension receptor blocker (ARB) for at least 30 days prior to study entry. Subjects on ACE inhibitors, with approval of their physician, have been switched to an ARB one week before initiating apheresis
Other optimal conventional therapy have been taken for at least 30 days prior to initiation of apheresis
Subject is able to complete the 6-minute walk test and the Kansas City Congestive Heart Failure Quality of Life Questionnaire (KCCQ)
Not currently in, or planning to participate in other studies

Exclusion Criteria:

Age <18 years, or >85 years of age
Poor venous access
CHF due to, or associated with, uncorrected primary valvular disease, uncorrected thyroid disease, obstructive/hypertrophic cardiomyopathy, pericardial disease, amyloidosis, active myocarditis, malfunctioning artificial heart valve, uncorrected congenital heart disease, or primary pulmonary hypertension
Subject has undergone a cardiac revascularization, valvular surgery, or bi-ventricular resynchronization procedure within six months prior to initiation of apheresis treatment
Subject is listed for transplantation and is expected to be transplanted within 6 months of initiation of apheresis treatment
Subject has had a myocardial infarction within 6 months prior to initiation of apheresis treatment
Subject with electrocardiogram (ECG) recorded at initial screening showing particular abnormalities
Subject has sustained VT, unless precipitated by an event such as an acute myocardial infarction, induction by catheter replacement, or by an electrophysiology procedure, or addressed by placement of an automatic implantable cardiac defibrillator (AICD)
Subject has an AICD that has fired for any ventricular arrhythmia within 90 days of the initial visit
Subject has unstable angina
Subject on a mechanical assist device
Subject has evidence of concomitant disease that may interfere with the natural course of the subjects underlying heart failure for the duration of the study
Subject has poorly controlled diabetes mellitus
Subject is currently taking study prohibited medication
Subject is unable to tolerate Beta blocker therapy or asthma, has a heart rate of <55 bpm, or the presence of second or third degree heart block without an implanted pacemaker, and first-degree heart block with a PR interval > 220 milliseconds
Subject has active disease, that in the opinion of the Investigator, may adversely affect the safety and efficacy of the treatment or the life span of the patient
Subject has history of, or is currently abusing alcohol or illicit drugs
Subject has serum potassium <4.0 mEq/L or >5.5mEq/L at initial visit
Subject has serum digoxin level of >1.2ng/mL at time of initial visit
Subject is pregnant or at risk of becoming pregnant during study
Subject is currently lactating
Subject has participated in a clinical drug or device trial in the last 90 days
Subject has demonstrated noncompliance with previous medical regimens
Subject is currently hospitalized, and is not hemodynamically stable, or has an acute cardiac or non-cardiac illness that requires further hospitalization
Subject is unable, or unwilling to change from an ACEI to an ARB
Subject has a known hypersensitivity to heparin or ethylene oxide
Subject has a known Low-density lipoprotein cholesterol (LDL-C) level of >130mg/dl