Ventricular Arrhythmias Incidence According to Sleep Apnea Syndrome in Implantable Cardioverter-Defibrillator (ICD) Patients

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. Identifier: NCT00708786
Recruitment Status : Completed
First Posted : July 2, 2008
Last Update Posted : July 2, 2008
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Brief Summary:
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 or disease Intervention/treatment Phase
Sleep Apnoea Device: ICD Device: CRT-D Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 755 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ventricular Arrhythmias Incidence According to Sleep Apnea Syndrome in ICD Patients
Study Start Date : April 2004
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Intervention Details:
    Device: ICD
    Ventricular arrhythmia treatment
    Device: CRT-D
    Ventricular arrhythmia treatment

Primary Outcome Measures :
  1. 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. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 12 months ]
  2. To report and compare the number of hospitalizations, mortality, and morbidity according to Respiratory Disturbance Index (RDI). [ Time Frame: 12 months ]
  3. 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 [ Time Frame: 12 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

    • Survival of at least one episode of cardiac arrest due to VT or VF not due to a transient or reversible cause, or presumed to be due to VF when electrophysiological testing is precluded by other medical conditions; or
    • Spontaneous sustained ventricular tachycardia, or
    • Syncope of undetermined origin with clinically relevant haemodynamically significant sustained VT or VF induced at electrophysiological study when drug therapy is ineffective, not tolerated or not preferred, or
  • Class IIa Indication for ICD

    • Non-sustained VT with coronary disease, prior myocardial infarction, left ventricular dysfunction (≤ 40%) and inducible VF or sustained VT at electrophysiological study.
    • With prior myocardial infarction and LVEF less than 30 % (without prior life-threatening arrhythmia or sustained VT).
  • 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:

  • VT/VF is associated with drug toxicity, electrolyte imbalance, hypoxia, electrocution or other reversible cause;
  • VT/VF occurred during the acute phase of infarction (< 1 week) or during an unstable ischemic phase;
  • Incessant VT/VF;
  • Implanted pacemaker that is not going to be explanted or otherwise disabled;
  • Inability or refusal to provided informed consent
  • Tricuspid valvular disease or tricuspid mechanical heart valve (lead contraindication);
  • Unable to understand the purpose and plan of the study;
  • Geographically unstable or not available for follow-up as defined in the investigational plan;
  • Reduced life expectancy (≤ 1 year) for other than cardiovascular reasons;
  • Patient participating in another clinical study;
  • Patient of minor age (< 18 years);
  • Pregnancy (Women of childbearing potential are required to have a negative pregnancy test within seven days prior to enrollment).

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00708786

CHRU Hopital de la cavale blanche
Brest, France
Clermont Ferrand, France
CHU - Hopital Michallon
Grenoble, France, 38043
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 cedex 16, France, 75116
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
Vandoeuvre les 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
Sponsors and Collaborators
Principal Investigator: Frédéric Anselme, MD CHU Charles Nicolle - Rouen

Responsible Party: F. Anselme - Principal investigator, CHRU Charles Nicolle Identifier: NCT00708786     History of Changes
Other Study ID Numbers: ITAC01-VISION
First Posted: July 2, 2008    Key Record Dates
Last Update Posted: July 2, 2008
Last Verified: June 2008

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases