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The purpose of this study is to report the incidence of ventricular arrhythmias correlated to the SAS and to focus on the interest of diagnosing Sleep-disorders breathing in ICD patients. This diagnosis will be assessed by an ambulatory nasal pressure recording with portable multi-channel recorder associated to a complete SAS related symptoms questionnaire.This clinical trial will be the first step to gather information about the suspected sleep relation between ventricular arrhythmias and Sleep breathing disorders, in order to improve the management and treatment of such arrhythmias in next generation of defibrillators which will integrate a minute ventilation sensor able to monitor breathing.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICD | Device | Ventricular arrhythmia treatment | ||
| CRT-D | Device | Ventricular arrhythmia treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of this study is to assess the correlation between ventricular arrhythmias and Sleep apnoea syndrome in ICD patients during a 12-month follow-up. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the number of arrhythmias in the morning (between 06:00 and 12:00 AM). The circadian distribution of global arrhythmias will be presented. | 12 months | |
| To report and compare the number of hospitalizations, mortality, and morbidity according to Respiratory Disturbance Index (RDI). |
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Inclusion Criteria:
Patients who are at risk of sudden death due to ventricular arrhythmia and who satisfy at least one of the following criteria are eligible for enrolment:
Class I indications for ICD
Class IIa Indication for ICD
Patients candidate for cardiac resynchronization therapy (CRT) need to be in functional Class III or IV of the NYHA classification.
Patients will be included only after having granted their informed consent to participate in the study, preceded by the delivery of appropriate information
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frédéric Anselme, MD | CHU Charles Nicolle - Rouen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU Hopital de la cavale blanche | Brest | France | ||||
| CHU |
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| 12 months |
| To evaluate the incidence of adverse events in the studied population: device-related adverse events with an actual or potential effect on the patient, serious adverse events not related to the device, mortality, and unanticipated adverse device effects | 12 months |
| Clermont-Ferrand |
| France |
| CHU - Hopital Michallon | Grenoble | 38043 | France |
| CHU Dupuytren | Limoges | France |
| Hopital cardiologique | Lyon | France |
| Hopital Saint Joseph et saint Luc | Lyon | France |
| Hopital Nord | Marseille | France |
| CHR Notre Dame de Bonsecours | Metz | France |
| CH Montpellier | Montpellier | France |
| Nouvelle Clinique Nantaise | Nantes | France |
| Clinique Bizet | Paris | 75116 | France |
| Clinique Bizet | Paris | France |
| CH Pau | Pau | France |
| CHU Hopital la Milétrie | Poitiers | France |
| CHR Cardiologie A | Rennes | France |
| CHU Charles Nicolle | Rouen | France |
| Clinique Pasteur | Toulouse | France |
| CHRU Hopital Trousseau | Tours | France |
| Clinique Saint gatien | Tours | France |
| CHRU Brabois | Vandœuvre-lès-Nancy | France |
| Herz-Kreislauf-Klinik Bevensen AG | Bad Bevensen | Germany |
| Universitatsklinikum Hamburg Eppendorf | Hamburg | Germany |
| Prof. Frey Praxis Starnberg | Starnberg | Germany |
| Onassis Cardiac Surgery Center | Athens | Greece |
| Ospedale Mellini | Chiari (BS) | Italy |
| Osp. Civile | Desio | Italy |
| Casa di Cura Montevergine | Mercogliano | Italy |
| Policlinico de Modenna | Modenna | Italy |
| Instituto di Cura | Pavia | Italy |
| Hospitale civile Guglielmo da Saliceto | Piacenza | Italy |
| Policlinico San Donato | San Donato | Italy |
| 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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