NCT00708786

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

Ventricular Arrhythmias Incidence According to Sleep Apnea Syndrome in ICD Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 755 (estimated)
• Sponsor: LivaNova · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	ICD	Ventricular arrhythmia treatment
DEVICE	CRT-D	Ventricular arrhythmia treatment

Timeline

• Start date: 2004-04-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2008-07-02
• Last updated: 2008-07-02

Locations

31 sites across 4 countries: France, Germany, Greece, Italy