NCT00708786

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
755

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2004

Longer than P75 for phase_4

Geographic Reach
4 countries

31 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2008

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 2, 2008

Completed
Last Updated

July 2, 2008

Status Verified

June 1, 2008

Enrollment Period

3.5 years

First QC Date

April 7, 2008

Last Update Submit

June 30, 2008

Conditions

Sleep Apnoea

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (3)

  • 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.

    12 months

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

    12 months

  • 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

    12 months

Interventions

ICDDEVICE

Ventricular arrhythmia treatment

CRT-DDEVICE

Ventricular arrhythmia treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

CHRU Hopital de la cavale blanche

Brest, France

Location

CHU

Clermont-Ferrand, France

Location

CHU - Hopital Michallon

Grenoble, 38043, France

Location

CHU Dupuytren

Limoges, France

Location

Hopital cardiologique

Lyon, France

Location

Hopital Saint Joseph et saint Luc

Lyon, France

Location

Hopital Nord

Marseille, France

Location

CHR Notre Dame de Bonsecours

Metz, France

Location

CH Montpellier

Montpellier, France

Location

Nouvelle Clinique Nantaise

Nantes, France

Location

Clinique Bizet

Paris, 75116, France

Location

Clinique Bizet

Paris, France

Location

CH Pau

Pau, France

Location

CHU Hopital la Milétrie

Poitiers, France

Location

CHR Cardiologie A

Rennes, France

Location

CHU Charles Nicolle

Rouen, France

Location

Clinique Pasteur

Toulouse, France

Location

CHRU Hopital Trousseau

Tours, France

Location

Clinique Saint gatien

Tours, France

Location

CHRU Brabois

Vandœuvre-lès-Nancy, France

Location

Herz-Kreislauf-Klinik Bevensen AG

Bad Bevensen, Germany

Location

Universitatsklinikum Hamburg Eppendorf

Hamburg, Germany

Location

Prof. Frey Praxis Starnberg

Starnberg, Germany

Location

Onassis Cardiac Surgery Center

Athens, Greece

Location

Ospedale Mellini

Chiari (BS), Italy

Location

Osp. Civile

Desio, Italy

Location

Casa di Cura Montevergine

Mercogliano, Italy

Location

Policlinico de Modenna

Modenna, Italy

Location

Instituto di Cura

Pavia, Italy

Location

Hospitale civile Guglielmo da Saliceto

Piacenza, Italy

Location

Policlinico San Donato

San Donato, Italy

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Frédéric Anselme, MD

    CHU Charles Nicolle - Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 7, 2008

First Posted

July 2, 2008

Study Start

April 1, 2004

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

July 2, 2008

Record last verified: 2008-06

Locations

DE(3)IT(7)FR(20)GR(1)