Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-04-08 @ 10:23 AM
Study NCT ID:
NCT01979120
Status:
UNKNOWN
Last Update Posted:
2013-11-08
First Post:
2013-11-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of the "ApneaScan" Algorithm for the Detection of Sleep Disordered Breathing in Chronic Heart Failure
Sponsor:
Dr. Christoph Schukro
Organization:
Study Overview
Official Title:
Validation of the "ApneaScan" Algorithm for the Detection of Sleep Disordered Breathing in Patients With Stable Symptomatic Chronic Heart Failure
Status:
UNKNOWN
Status Verified Date:
2013-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VASA
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: