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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Apnea-Hypopnea-Index | 1 night |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-Hypopnea-Index >/= 30 (in-laboratory polysomnography) | 1 night |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | 2 years | |
| Hospitalization | 2 years | |
| ICD therapies (i.e. shock or anti-tachycardia pacing) |
Inclusion Criteria:
Exclusion Criteria:
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Patients with stable symptomatic chronic heart failure and implanted ICD/CRT-D of the "INCEPTA" series
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christoph Schukro, MD, PhD | Contact | +43140400 | 4614 | christoph.schukro@meduniwien.ac.at |
| Name | Affiliation | Role |
|---|---|---|
| Christoph Schukro, MD, PhD | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hietzing Hospital | Recruiting | Vienna | Austria |
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| 2 years |
| atrial fibrillation | 2 years |
| routine B-type natriuretic peptide | only if applicable! | 1 night |
| Medical University of Vienna | Recruiting | Vienna | Austria |
|
| SMZO | Recruiting | Vienna | Austria |
|
| Wilhelminenspital | Recruiting | Vienna | Austria |
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| Wiener Neustadt Hospital | Not yet recruiting | Wiener Neustadt | Austria |
|
| Heart and Diabetes centre NRW | Active, not recruiting | Bad Oeynhausen | Germany |
| Klinikum Coburg | Recruiting | Coburg | Germany |
|
| University of Leipzig | Active, not recruiting | Leipzig | Germany |
| Reinbek Hospital | Recruiting | Reinbek | Germany |
|
| Kyushu University | Not yet recruiting | Kyushu | Japan |
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| Tokyo Medical University | Not yet recruiting | Tokyo | Japan |
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| Tottori University | Not yet recruiting | Tottori | Japan |
|
| Juntendo University School of Medicine | Not yet recruiting | Urayasu | Japan |
|
| University of Geneva | Recruiting | Geneva | Switzerland |
|
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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