Validation of the "ApneaScan" Algorithm for the Detection of Sleep Disordered Breathing in Chronic Heart Failure (VASA)
Recruitment status was: Recruiting
A prospective observational multi-centre study for the validation of the ApneaScan algorithm (integrated in ICD devices (with or without cardiac resynchronization therapy function) of the "Incepta" series for the screening of sleep disordered breathing in patients with stable symptomatic chronic heart failure, using portable polygraphy monitoring device ("Embletta Gold") as reference for the Apnea-Hypopnea-Index (AHI).
Secondary objectives are the detection of severe sleep disordered breathing in patients with clinically indicated in-laboratory polysomnography, as well as correlations of the AHI detected by ApneaScan with other clinical endpoints like mortality, hospitalization, atrial fibrillation and ventricular arrhythmia.
Chronic Heart Failure
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Validation of the "ApneaScan" Algorithm for the Detection of Sleep Disordered Breathing in Patients With Stable Symptomatic Chronic Heart Failure|
- Apnea-Hypopnea-Index [ Time Frame: 1 night ] [ Designated as safety issue: No ]
- Apnea-Hypopnea-Index >/= 30 (in-laboratory polysomnography) [ Time Frame: 1 night ] [ Designated as safety issue: No ]
- Mortality [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Hospitalization [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- ICD therapies (i.e. shock or anti-tachycardia pacing) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- atrial fibrillation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- routine B-type natriuretic peptide [ Time Frame: 1 night ] [ Designated as safety issue: No ]only if applicable!
|Study Start Date:||December 2012|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
only 1 cohort!
All patients already got an ICD implanted which includes an algorithm for screening of sleep-disordered breathing and will be examined by an portable polygraphy monitor in order to compare the Apnea-Hypopnea-Index.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01979120
|Medical University of Vienna|
|Wiener Neustadt Hospital|
|Wiener Neustadt, Austria|
|Heart and Diabetes centre NRW|
|Bad Oeynhausen, Germany|
|University of Leipzig|
|Tokyo Medical University|
|Juntendo University School of Medicine|
|University of Geneva|
|Principal Investigator:||Christoph Schukro, MD, PhD||Medical University of Vienna|