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.
Study Type
OBSERVATIONAL
Enrollment
200
Hietzing Hospital
Vienna, Austria
RECRUITINGMedical University of Vienna
Vienna, Austria
RECRUITINGSMZO
Vienna, Austria
RECRUITINGWilhelminenspital
Vienna, Austria
RECRUITINGWiener Neustadt Hospital
Wiener Neustadt, Austria
NOT_YET_RECRUITINGHeart and Diabetes centre NRW
Bad Oeynhausen, Germany
ACTIVE_NOT_RECRUITINGKlinikum Coburg
Coburg, Germany
RECRUITINGUniversity of Leipzig
Leipzig, Germany
ACTIVE_NOT_RECRUITINGReinbek Hospital
Reinbek, Germany
RECRUITINGKyushu University
Kyushu, Japan
NOT_YET_RECRUITING...and 4 more locations
Apnea-Hypopnea-Index
Time frame: 1 night
Apnea-Hypopnea-Index >/= 30 (in-laboratory polysomnography)
Time frame: 1 night
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