Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF)

Inclusion Criteria:

• Subjects with heart failure classified as New York Heart Association (NYHA) Class III and IV
• Subject has been managed with standard medical therapy for heart failure (such as diuretic, angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blockers (ARB), and beta-blocker for at least 3 months prior to the baseline evaluation
• Subject must have at least one heart failure-related hospitalization or emergency department visit requiring intravenous treatment within 6 months prior to baseline evaluation

Exclusion Criteria:

• Subjects who are likely to be transplanted within 6 months from randomization or will remain hospitalized until transplantation
• Subjects with severe COPD or restrictive airway disease (recommended FEV1 less than or equal to 1 liter or 50% predicted)
• Subjects who are on continuous positive inotropic therapy
• Subjects with known atrial or ventricular septal defects
• Subjects with mechanical right heart valves
• Subjects with stenotic tricuspid or pulmonary valves
• Subjects with a presently implanted non-compatible pacemaker or ICD
• Subjects with cardiac resynchronization therapy which has not achieved optimal programming for more than 3 months
• Subjects with a major cardiovascular event within 3 months prior to baseline evaluation
• Subjects with a severe non-cardiac condition limiting 6 month survival
• Subjects with a primary diagnosis of pulmonary artery hypertension
• Subjects with serum creatinine greater than or equal to 3.5 mg/dL or on chronic renal dialysis
• Subjects enrolled in concurrent studies that may confound the results of this study
• Women who are pregnant or with child bearing potential and who are not on a reliable form of birth control