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

Sleep Apnoea Clinical Trial

Official title:

Ventricular Arrhythmias Incidence According to Sleep Apnea Syndrome in ICD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00708786
• Other study ID #: ITAC01-VISION
• Status: Completed
• Phase: Phase 4
• First received: April 7, 2008
• Last updated: June 30, 2008
• Start date: April 2004
• Est. completion date: October 2007

Study information

• Verified date: June 2008
• Source: LivaNova
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Institutional Ethical CommitteeItaly: Ethics CommitteeGermany: Ethics CommissionUnited Kingdom: Research Ethics CommitteeGreece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 755
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnoea

Intervention

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

Locations

Country	Name	City	State
France	CHRU Hopital de la cavale blanche	Brest
France	CHU	Clermont Ferrand
France	CHU - Hopital Michallon	Grenoble
France	CHU Dupuytren	Limoges
France	Hopital cardiologique	Lyon
France	Hopital Saint Joseph et saint Luc	Lyon
France	Hopital Nord	Marseille
France	CHR Notre Dame de Bonsecours	Metz
France	CH Montpellier	Montpellier
France	Nouvelle Clinique Nantaise	Nantes
France	Clinique Bizet	Paris
France	Clinique Bizet	Paris cedex 16
France	CH Pau	Pau
France	CHU Hopital la Milétrie	Poitiers
France	CHR Cardiologie A	Rennes
France	CHU Charles Nicolle	Rouen
France	Clinique Pasteur	Toulouse
France	CHRU Hopital Trousseau	Tours
France	Clinique Saint gatien	Tours
France	CHRU Brabois	Vandoeuvre les Nancy
Germany	Herz-Kreislauf-Klinik Bevensen AG	Bad Bevensen
Germany	Universitatsklinikum Hamburg Eppendorf	Hamburg
Germany	Prof. Frey Praxis Starnberg	Starnberg
Greece	Onassis Cardiac Surgery Center	Athens
Italy	Ospedale Mellini	Chiari (BS)
Italy	Osp. Civile	Desio
Italy	Casa di Cura Montevergine	Mercogliano
Italy	Policlinico de Modenna	Modenna
Italy	Instituto di Cura	Pavia
Italy	Hospitale civile Guglielmo da Saliceto	Piacenza
Italy	Policlinico San Donato	San Donato

Sponsors (1)

Lead Sponsor	Collaborator
LivaNova

Countries where clinical trial is conducted

France,  Germany,  Greece,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	To report and compare the number of hospitalizations, mortality, and morbidity according to Respiratory Disturbance Index (RDI).		12 months	No
Secondary	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	No