Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00708786
Recruitment Status : Completed
First Posted : July 2, 2008
Last Update Posted : July 2, 2008
Sponsor:
Information provided by:
LivaNova

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.

Condition or disease Intervention/treatment Phase
Sleep Apnoea Device: ICD Device: CRT-D Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 755 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ventricular Arrhythmias Incidence According to Sleep Apnea Syndrome in ICD Patients
Study Start Date : April 2004
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea


Intervention Details:
  • Device: ICD
    Ventricular arrhythmia treatment
  • Device: CRT-D
    Ventricular arrhythmia treatment


Primary Outcome Measures :
  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. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. To report and compare the number of hospitalizations, mortality, and morbidity according to Respiratory Disturbance Index (RDI). [ Time Frame: 12 months ]
  3. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00708786


Locations
Show Show 31 study locations
Sponsors and Collaborators
LivaNova
Investigators
Layout table for investigator information
Principal Investigator: Frédéric Anselme, MD CHU Charles Nicolle - Rouen

Layout table for additonal information
Responsible Party: F. Anselme - Principal investigator, CHRU Charles Nicolle
ClinicalTrials.gov Identifier: NCT00708786    
Other Study ID Numbers: ITAC01-VISION
First Posted: July 2, 2008    Key Record Dates
Last Update Posted: July 2, 2008
Last Verified: June 2008
Additional relevant MeSH terms:
Layout table for MeSH terms
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases