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Sponsored by: |
Sorin Group |
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Information provided by: | Sorin Group |
ClinicalTrials.gov Identifier: | NCT00708786 |
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.
Condition | Intervention | Phase |
---|---|---|
Sleep Apnoea |
Device: ICD Device: CRT-D |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment |
Official Title: | Ventricular Arrhythmias Incidence According to Sleep Apnea Syndrome in ICD Patients |
Estimated Enrollment: | 755 |
Study Start Date: | April 2004 |
Study Completion Date: | October 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Class I indications for ICD
Class IIa Indication for ICD
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:
France | |
CH Montpellier | |
Montpellier, France | |
CH Pau | |
Pau, France | |
CHR Cardiologie A | |
Rennes, France | |
CHU - Hopital Michallon | |
Grenoble, France, 38043 | |
CHU Charles Nicolle | |
Rouen, France | |
Clinique Bizet | |
Paris cedex 16, France, 75116 | |
Clinique Bizet | |
Paris, France | |
CHU | |
Clermont Ferrand, France | |
CHRU Hopital Trousseau | |
Tours, France | |
Clinique Saint gatien | |
Tours, France | |
Hopital Nord | |
Marseille, France | |
CHRU Brabois | |
Vandoeuvre les Nancy, France | |
Hopital cardiologique | |
Lyon, France | |
Hopital Saint Joseph et saint Luc | |
Lyon, France | |
CHRU Hopital de la cavale blanche | |
Brest, France | |
Nouvelle Clinique Nantaise | |
Nantes, France | |
CHU Dupuytren | |
Limoges, France | |
Clinique Pasteur | |
Toulouse, France | |
CHR Notre Dame de Bonsecours | |
Metz, France | |
CHU Hopital la Milétrie | |
Poitiers, France | |
Germany | |
Prof. Frey Praxis Starnberg | |
Starnberg, Germany | |
Herz-Kreislauf-Klinik Bevensen AG | |
Bad Bevensen, Germany | |
Universitatsklinikum Hamburg Eppendorf | |
Hamburg, Germany | |
Greece | |
Onassis Cardiac Surgery Center | |
Athens, Greece | |
Italy | |
Osp. Civile | |
Desio, Italy | |
Ospedale Mellini | |
Chiari (BS), Italy | |
Policlinico San Donato | |
San Donato, Italy | |
Hospitale civile Guglielmo da Saliceto | |
Piacenza, Italy | |
Casa di Cura Montevergine | |
Mercogliano, Italy | |
Policlinico de Modenna | |
Modenna, Italy | |
Instituto di Cura | |
Pavia, Italy |
Principal Investigator: | Frédéric Anselme, MD | CHU Charles Nicolle - Rouen |
Responsible Party: | CHRU Charles Nicolle ( F. Anselme - Principal investigator ) |
Study ID Numbers: | ITAC01-VISION |
Study First Received: | April 7, 2008 |
Last Updated: | June 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00708786 |
Health Authority: | France: Afssaps - French Health Products Safety Agency; France: Institutional Ethical Committee; Italy: Ethics Committee; Germany: Ethics Commission; United Kingdom: Research Ethics Committee; Greece: Ethics Committee |
Signs and Symptoms Sleep Apnea Syndromes Heart Diseases Respiratory Tract Diseases Apnea Respiration Disorders |
Dyssomnias Sleep Disorders Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic Arrhythmias, Cardiac |
Pathologic Processes Nervous System Diseases Cardiovascular Diseases |