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Validation of the "ApneaScan" Algorithm for the Detection of Sleep Disordered Breathing in Chronic Heart Failure (VASA)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by Dr. Christoph Schukro, Medical University of Vienna.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01979120
First Posted: November 8, 2013
Last Update Posted: November 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Dr. Christoph Schukro, Medical University of Vienna
November 3, 2013
November 8, 2013
November 8, 2013
December 2012
August 2014   (Final data collection date for primary outcome measure)
Apnea-Hypopnea-Index [ Time Frame: 1 night ]
Same as current
No Changes Posted
Apnea-Hypopnea-Index >/= 30 (in-laboratory polysomnography) [ Time Frame: 1 night ]
Same as current
  • Mortality [ Time Frame: 2 years ]
  • Hospitalization [ Time Frame: 2 years ]
  • ICD therapies (i.e. shock or anti-tachycardia pacing) [ Time Frame: 2 years ]
  • atrial fibrillation [ Time Frame: 2 years ]
  • routine B-type natriuretic peptide [ Time Frame: 1 night ]
    only if applicable!
Same as current
 
Validation of the "ApneaScan" Algorithm for the Detection of Sleep Disordered Breathing in Chronic Heart Failure
Validation of the "ApneaScan" Algorithm for the Detection of Sleep Disordered Breathing in Patients With Stable Symptomatic Chronic Heart Failure

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients with stable symptomatic chronic heart failure and implanted ICD/CRT-D of the "INCEPTA" series
  • Sleep-disordered Breathing
  • Chronic Heart Failure
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
200
Not Provided
August 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age over 18 years
  • Patient´s written informed consent
  • Patients with a cardiac rhythm management device (ICD with or without cardiac resynchronization therapy function) of the "Incepta" series (including the ApneaScan algorithm) already implanted for at least 8 weeks (corresponding to the duration of the leads´ healing process); in order to standardize the enrollment period, inclusion should be effected between the first (the earliest 8 weeks after implantation) and the second routine control of ICD-function (the latest 9 months after implantation)
  • Stable symptomatic chronic heart failure for either ischemic or non-ischemic reason (moderately to severely impaired systolic left ventricular function with NYHA-class II to III) under optimal pharmacological treatment (according to guidelines 2012 of the European Society of Cardiology)

Exclusion Criteria:

  • Unstable heart failure (NYHA-class IV) or asymptomatic chronic heart failure (including patients with very mild exercise induced dyspnea, i.e. NYHA-class I)
  • Patients already treated for sleep apnea syndrome (i.e. continuous positive airway pressure mask) or chronic obstructive pulmonary disease with GOLD-class IV (i.e. long-term oxygen therapy)
  • A limited AHI detection by the ApneaScan algorithm until the planned inclusion (randomly defined by <50% of countable AHI detection-points within the last 2 weeks).
  • Patients with limited mobility due to orthopedic, neurologic or oncologic diseases (because of restricted assessment of exercise induced dyspnea)
  • Patients on dialysis (either acute or chronic)
  • Alcoholism or regular intake of hypnotics
  • Pregnancy and lactation
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany,   Japan,   Switzerland
 
 
NCT01979120
ISROTH20033
Yes
Not Provided
Not Provided
Dr. Christoph Schukro, Medical University of Vienna
Dr. Christoph Schukro
Boston Scientific Corporation
Principal Investigator: Christoph Schukro, MD, PhD Medical University of Vienna
Medical University of Vienna
August 2013