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