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

NCT00708786 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 755

Last updated 2008-07-02

No results posted yet for this study

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

Interventions

DEVICE

ICD

Ventricular arrhythmia treatment

DEVICE

CRT-D

Ventricular arrhythmia treatment

Sponsors & Collaborators

  • LivaNova

    lead INDUSTRY

Principal Investigators

  • Frédéric Anselme, MD · CHU Charles Nicolle - Rouen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • France
  • Germany
  • Greece
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00708786 on ClinicalTrials.gov