Status:
COMPLETED
Ventricular Arrhythmias Incidence According to Sleep Apnea Syndrome in Implantable Cardioverter-Defibrillator (ICD) Patients
Lead Sponsor:
LivaNova
Conditions:
Sleep Apnoea
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 diagnos...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2007
Estimated Enrollment :
755 Patients enrolled
Trial Details
Trial ID
NCT00708786
Start Date
April 1 2004
End Date
October 1 2007
Last Update
July 2 2008
Active Locations (31)
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1
CHRU Hopital de la cavale blanche
Brest, France
2
CHU
Clermont-Ferrand, France
3
CHU - Hopital Michallon
Grenoble, France, 38043
4
CHU Dupuytren
Limoges, France