Prospective Evaluation of Heart Failure Patients With Central Sleep Apnea

Inclusion Criteria:

Subject is willing and able to comply with this protocol and has signed an IRB/MEC approved informed consent (as well as Privacy Protection Authorization in the United States)
Age is greater than or equal to 18 years
Known recent history of sleep disordered breathing of predominantly central origin, as evidenced by an overnight PSG with EEG and at least 4 hours of recording that was conducted within 60 days of enrollment and demonstrating the following characteristics:
AHI greater than or equal to 20
greater than or equal to 50% of classified events of a central nature
less than 20% of the total AHI comprised of obstructive apnea events
Diagnosed chronic heart failure, with medications optimized and stable for at least 30 days prior to the screening PSG, or since the date of the earliest test used for baseline, whichever is longer. Optimal medications include: beta blockade, ACE-I or ARB and diuretics unless contraindicated or not considered medically necessary.

Exclusion Criteria:

Current or intended use of any mask-based therapy for central sleep apnea
Baseline oxygen saturation less than or equal to 90% on a stable FiO2
Severe Chronic Obstructive Pulmonary Disease (COPD) (per GOLD classification system)
History of cerebrovascular accident (CVA), myocardial infarction (MI), coronary artery bypass grafting (CABG) surgery, or percutaneous coronary intervention (PCI), or any cardiac ablation procedure within the 3 months prior to the study
Unstable angina
History of primary pulmonary hypertension
Currently enrolled in a non-observational (ie, interventional) clinical study that could confound the results of this study
If subject has an implanted cardiac resynchronization device (CRT), it must have been implanted at least 3 months before enrollment; any other device must have been implanted at least 30 days prior to enrollment
Life expectancy of less than 6 months