Clinical trial NCT00708786: Ventricular Arrhythmias Incidence According to Sleep Apnea Syndrome in Implantable Cardioverter-Defibrillator (ICD) Patients
Official title: Ventricular Arrhythmias Incidence According to Sleep Apnea Syndrome in ICD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sleep Apnoea
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
First posted: 2008-07-02
Enrollment: 755
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
measure: 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.
timeFrame: 12 months
measure: To report and compare the number of hospitalizations, mortality, and morbidity according to Respiratory Disturbance Index (RDI).
timeFrame: 12 months
measure: 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
timeFrame: 12 months
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU Hopital de la cavale blanche
city: Clermont Ferrand
country: France
facility: CHU
city: Grenoble
country: France
facility: CHU - Hopital Michallon
city: Limoges
country: France
facility: CHU Dupuytren
city: Lyon
country: France
facility: Hopital cardiologique
city: Lyon
country: France
facility: Hopital Saint Joseph et saint Luc
city: Marseille
country: France
facility: Hopital Nord
city: Metz
country: France
facility: CHR Notre Dame de Bonsecours
city: Montpellier
country: France
facility: CH Montpellier
city: Nantes
country: France
facility: Nouvelle Clinique Nantaise
city: Paris cedex 16
country: France
facility: Clinique Bizet
city: Paris
country: France
facility: Clinique Bizet
city: Pau
country: France
facility: CH Pau
city: Poitiers
country: France
facility: CHU Hopital la Milétrie
city: Rennes
country: France
facility: CHR Cardiologie A
city: Rouen
country: France
facility: CHU Charles Nicolle
city: Toulouse
country: France
facility: Clinique Pasteur
city: Tours
country: France
facility: CHRU Hopital Trousseau
city: Tours
country: France
facility: Clinique Saint gatien
city: Vandoeuvre les Nancy
country: France
facility: CHRU Brabois
city: Bad Bevensen
country: Germany
facility: Herz-Kreislauf-Klinik Bevensen AG
city: Hamburg
country: Germany
facility: Universitatsklinikum Hamburg Eppendorf
city: Starnberg
country: Germany
facility: Prof. Frey Praxis Starnberg
city: Athens
country: Greece
facility: Onassis Cardiac Surgery Center
city: Chiari (BS)
country: Italy
facility: Ospedale Mellini
city: Desio
country: Italy
facility: Osp. Civile
city: Mercogliano
country: Italy
facility: Casa di Cura Montevergine
city: Modenna
country: Italy
facility: Policlinico de Modenna
city: Pavia
country: Italy
facility: Instituto di Cura
city: Piacenza
country: Italy
facility: Hospitale civile Guglielmo da Saliceto
city: San Donato
country: Italy
facility: Policlinico San Donato
Study officials:
affiliation: CHU Charles Nicolle - Rouen
name: Frédéric Anselme, MD
role: PRINCIPAL_INVESTIGATOR
References: