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

Primary Purpose

Sleep Apnoea

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
ICD
CRT-D
Sponsored by
LivaNova
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnoea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • CHRU Hopital de la cavale blanche
  • CHU
  • CHU - Hopital Michallon
  • CHU Dupuytren
  • Hopital cardiologique
  • Hopital Saint Joseph et saint Luc
  • Hopital Nord
  • CHR Notre Dame de Bonsecours
  • CH Montpellier
  • Nouvelle Clinique Nantaise
  • Clinique Bizet
  • Clinique Bizet
  • CH Pau
  • CHU Hopital la Milétrie
  • CHR Cardiologie A
  • CHU Charles Nicolle
  • Clinique Pasteur
  • CHRU Hopital Trousseau
  • Clinique Saint gatien
  • CHRU Brabois
  • Herz-Kreislauf-Klinik Bevensen AG
  • Universitatsklinikum Hamburg Eppendorf
  • Prof. Frey Praxis Starnberg
  • Onassis Cardiac Surgery Center
  • Ospedale Mellini
  • Osp. Civile
  • Casa di Cura Montevergine
  • Policlinico de Modenna
  • Instituto di Cura
  • Hospitale civile Guglielmo da Saliceto
  • Policlinico San Donato

Outcomes

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.

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.
To report and compare the number of hospitalizations, mortality, and morbidity according to Respiratory Disturbance Index (RDI).
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

Full Information

First Posted
April 7, 2008
Last Updated
June 30, 2008
Sponsor
LivaNova
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1. Study Identification

Unique Protocol Identification Number
NCT00708786
Brief Title
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

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
LivaNova

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnoea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
755 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
ICD
Intervention Description
Ventricular arrhythmia treatment
Intervention Type
Device
Intervention Name(s)
CRT-D
Intervention Description
Ventricular arrhythmia treatment
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
To report and compare the number of hospitalizations, mortality, and morbidity according to Respiratory Disturbance Index (RDI).
Time Frame
12 months
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric Anselme, MD
Organizational Affiliation
CHU Charles Nicolle - Rouen
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU Hopital de la cavale blanche
City
Brest
Country
France
Facility Name
CHU
City
Clermont Ferrand
Country
France
Facility Name
CHU - Hopital Michallon
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
CHU Dupuytren
City
Limoges
Country
France
Facility Name
Hopital cardiologique
City
Lyon
Country
France
Facility Name
Hopital Saint Joseph et saint Luc
City
Lyon
Country
France
Facility Name
Hopital Nord
City
Marseille
Country
France
Facility Name
CHR Notre Dame de Bonsecours
City
Metz
Country
France
Facility Name
CH Montpellier
City
Montpellier
Country
France
Facility Name
Nouvelle Clinique Nantaise
City
Nantes
Country
France
Facility Name
Clinique Bizet
City
Paris cedex 16
ZIP/Postal Code
75116
Country
France
Facility Name
Clinique Bizet
City
Paris
Country
France
Facility Name
CH Pau
City
Pau
Country
France
Facility Name
CHU Hopital la Milétrie
City
Poitiers
Country
France
Facility Name
CHR Cardiologie A
City
Rennes
Country
France
Facility Name
CHU Charles Nicolle
City
Rouen
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
Country
France
Facility Name
CHRU Hopital Trousseau
City
Tours
Country
France
Facility Name
Clinique Saint gatien
City
Tours
Country
France
Facility Name
CHRU Brabois
City
Vandoeuvre les Nancy
Country
France
Facility Name
Herz-Kreislauf-Klinik Bevensen AG
City
Bad Bevensen
Country
Germany
Facility Name
Universitatsklinikum Hamburg Eppendorf
City
Hamburg
Country
Germany
Facility Name
Prof. Frey Praxis Starnberg
City
Starnberg
Country
Germany
Facility Name
Onassis Cardiac Surgery Center
City
Athens
Country
Greece
Facility Name
Ospedale Mellini
City
Chiari (BS)
Country
Italy
Facility Name
Osp. Civile
City
Desio
Country
Italy
Facility Name
Casa di Cura Montevergine
City
Mercogliano
Country
Italy
Facility Name
Policlinico de Modenna
City
Modenna
Country
Italy
Facility Name
Instituto di Cura
City
Pavia
Country
Italy
Facility Name
Hospitale civile Guglielmo da Saliceto
City
Piacenza
Country
Italy
Facility Name
Policlinico San Donato
City
San Donato
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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