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

This study has been completed.
Sponsor:
Information provided by:
Sorin Group
ClinicalTrials.gov Identifier:
NCT00708786
First received: April 7, 2008
Last updated: June 30, 2008
Last verified: June 2008
  Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ventricular Arrhythmias Incidence According to Sleep Apnea Syndrome in ICD Patients

Resource links provided by NLM:


Further study details as provided by Sorin Group:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To report and compare the number of hospitalizations, mortality, and morbidity according to Respiratory Disturbance Index (RDI). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00708786

Locations
France
CHRU Hopital de la cavale blanche
Brest, France
CHU
Clermont Ferrand, France
CHU - Hopital Michallon
Grenoble, France, 38043
CHU Dupuytren
Limoges, France
Hopital Saint Joseph et saint Luc
Lyon, France
Hopital cardiologique
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 cedex 16, France, 75116
CH Pau
Pau, France
CHU Hopital la Milétrie
Poitiers, France
CHR Cardiologie A
Rennes, France
CHU Charles Nicolle
Rouen, France
Clinique Pasteur
Toulouse, France
Clinique Saint gatien
Tours, France
CHRU Hopital Trousseau
Tours, France
CHRU Brabois
Vandoeuvre les Nancy, France
Germany
Herz-Kreislauf-Klinik Bevensen AG
Bad Bevensen, Germany
Universitatsklinikum Hamburg Eppendorf
Hamburg, Germany
Prof. Frey Praxis Starnberg
Starnberg, Germany
Greece
Onassis Cardiac Surgery Center
Athens, Greece
Italy
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
Sorin Group
Investigators
Principal Investigator: Frédéric Anselme, MD CHU Charles Nicolle - Rouen
  More Information

No publications provided

Responsible Party: F. Anselme - Principal investigator, CHRU Charles Nicolle
ClinicalTrials.gov Identifier: NCT00708786     History of Changes
Other Study ID Numbers: ITAC01-VISION
Study First Received: April 7, 2008
Last Updated: June 30, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee
Italy: Ethics Committee
Germany: Ethics Commission
United Kingdom: Research Ethics Committee
Greece: Ethics Committee

Additional relevant MeSH terms:
Apnea
Arrhythmias, Cardiac
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on April 16, 2014