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

NCT ID: NCT00708786

Last Updated: 2008-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 755 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2007-10-31

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.

Conditions

Sleep Apnoea

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

ICD

Ventricular arrhythmia treatment

Intervention Type: DEVICE

CRT-D

Ventricular arrhythmia treatment

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LivaNova

INDUSTRY

Sponsor Role: lead

Responsible Party

CHRU Charles Nicolle

Principal Investigators

Frédéric Anselme, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Charles Nicolle - Rouen

Locations

CHRU Hopital de la cavale blanche

Brest, , France

CHU

Clermont-Ferrand, , France

CHU - Hopital Michallon

Grenoble, , 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, , 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

Countries

France; Germany; Greece; Italy

Other Identifiers

ITAC01-VISION

Identifier Type: -

Identifier Source: org_study_id