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 mandibular advancement device for treatment of sleep apnea 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