Effect of Adaptive Servo Ventilation (ASV) on Survival and Hospital Admissions in Heart Failure

Inclusion Criteria:

- American Heart Association Stage B-D Heart failure due to ischemic, idiopathic or
hypertensive causes, present for at least 3 months

- Left Ventricular Ejection Fraction ≤ 45 %

- Optimal medical therapy for heart failure

- No change in active cardiac medications for 2 weeks prior to randomization,
beta-blockers must be started 3 months prior to randomization

- Sleep apnea with an AHI ≥ 15. Subjects with obstructive sleep apnea must also have an
Epworth Sleepiness Scale score of ≤ 10 and no or mild daytime sleepiness

- Written informed consent

Exclusion Criteria:

- Heart failure due to primary valvular heart disease

- Presence of moderate to severe mitral insufficiency due to intrinsic mitral valve
disease

- Hypertrophic obstructive or restrictive or post partum cardiomyopathy

- Exercise capacity limited by class IV angina pectoris

- Acute MI, cardiac surgery, PCI, AICD, or CRT within 3 months of randomization

- Active myocarditis

- Planned AICD or CRT

- Presence of a left-ventricular assist device

- Transplanted heart or expected to receive a transplanted heart within the next 6
months

- Pregnancy

- Current use of ASV or CPAP or treated with any investigational therapy during the last
4 weeks (including approved therapies being used in unapproved indications)

- A clinical history that would interfere with the objectives of this study or that
would in the investigator's opinion preclude safe conclusion of the study

- Any other medical, social, or geographical factor, which would make it unlikely that
the patient will comply with the study procedures (e.g. alcohol abuse, lack of
permanent residence, severe depression, disorientation, distant location, or history
of non-compliance)

- Any contraindication to ASV therapy as detailed in the device provider manual