Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
Phase 1: The European ASV Registry (short name) will investigate the use of Adaptive
 Servo-Ventilation in non-heart failure conditions. The purpose is to examine the effects of
 ASV on quality of life, daytime symptoms and sleep, to describe usage patterns of ASV with
 regards to patient characteristics and to document adverse events related to therapy for a
 therapy safety analysis. A pilot phase will enrol at least 200 patients to test the
 feasibility of the registry. After the pilot phase will be completed and an intermediate data
 analysis had been performed, the registry will be expanded over several countries across
 Europe with the goal of enrolling up to 800 patients over a period of 5 years. Phase 2: The
 READ-ASV Registry (short name) will investigate the use of Adaptive Servo-Ventilation in
 non-heart failure conditions. The purpose is to examine the effects of ASV on quality of
 life, daytime symptoms and sleep, to describe usage patterns of ASV with regards to patient
 characteristics and to document adverse events related to therapy for a therapy safety
 analysis.
Phase 1: The collection of data will be performed during the course of clinical routine. In
 regular clinical practice, a first control visit (i.e. Follow-up number one) should occur
 during the first 6 months. Further follow-up visits are only indicated when the patient is
 reporting problems during the course of therapy. We recommend FU visit at least once year
 (after the first routine FU visit). Each patient will be included for 6 months, the total
 duration of phase 1 of the registry. Phase 2: The pilot phase 1 enrolled over 200 patients.
 After completion of the pilot phase the registry expands to 1 additional country in Europe
 with the goal of enrolling up to 800 patients over a period of 4 years. The collection of
 data will be performed during the course of clinical routine. In regular clinical practice, a
 first control visit (i.e. Follow-up number one) should occur after the first 12 months of
 therapy use. Further follow-up visits are only indicated when the patient is reporting
 problems during the course of therapy. Each patient will be included for a maximum of 15
 months, whereas serious events will be tracked throughout the total duration of phase I and
 II of the registry.
Inclusion Criteria:

 -  Patients over ≥18 years of Age

 -  Prescription of ResMed AirCurve 10 CS PaceWave or S9 AutoSet CS PaceWave for treatment
 of ASV

 -  Naive to ASV Treatment

 -  Able to fully understand information on data protection and provide written informed
 consent

 Exclusion Criteria:

 - Heart Failure (HF) with a Left Ventricular Ejection Fraction (LVEF) <45% and CSA >50%
 central apneas of all apneas

 Phase 2: Inclusion Criteria:

 -  ≥ 18 years old.

 -  Indication for treatment with ASV according to applicable medical guidelines.

 -  Use of eligible ResMed devices for treatment with ASV according to the Instructions
 For Use of the corresponding device.

 -  Naive to ASV treatment (max. 7 days between start of ASV therapy and enrolment).

 -  Able to fully understand information on data protection and provide written informed
 consent for use of their medical data.

 Phase 2: Exclusion Criteria:

 -  Chronic, symptomatic heart failure (NYHA 2-4) with reduced left ventricular ejection
 fraction (LVEF ≤ 45%) and moderate to severe predominant central sleep apnea.