Sleep ApnoeaPhase 4NCT00708786

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

A Phase 4 study testing ICD and CRT-D in people with Sleep Apnoea, run by LivaNova at 31 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Sleep Apnoea
What is being tested?: ICD and CRT-D
Type of treatment: Medical device
How many people: 755 participants
Where: 31 sitesin 4 countries
Study dates: Apr 2004to Oct 2007
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 10Show fewer

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

Who cannot join

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);

Show all 12Show fewer

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).

Trial locations and contacts

31 sites in 4 countries.

Country

City, postcode or hospital

31 sites in 4 countries

France20 sites

CHRU Hopital de la cavale blanche
Brest
CHU
Clermont-Ferrand
CHU - Hopital Michallon
Grenoble, 38043
CHU Dupuytren
Limoges
Hopital cardiologique
Lyon
Hopital Saint Joseph et saint Luc
Lyon
Hopital Nord
Marseille
CHR Notre Dame de Bonsecours
Metz
CH Montpellier
Montpellier
Nouvelle Clinique Nantaise
Nantes
Clinique Bizet
Paris, 75116
Clinique Bizet
Paris
CH Pau
Pau
CHU Hopital la Milétrie
Poitiers
CHR Cardiologie A
Rennes
CHU Charles Nicolle
Rouen
Clinique Pasteur
Toulouse
CHRU Hopital Trousseau
Tours
Clinique Saint gatien
Tours
CHRU Brabois
Vandœuvre-lès-Nancy

Other trials in France

Italy7 sites

Ospedale Mellini
Chiari (BS)
Osp. Civile
Desio
Casa di Cura Montevergine
Mercogliano
Policlinico de Modenna
Modenna
Instituto di Cura
Pavia
Hospitale civile Guglielmo da Saliceto
Piacenza
Policlinico San Donato
San Donato

Other trials in Italy

Germany3 sites

Herz-Kreislauf-Klinik Bevensen AG
Bad Bevensen
Universitatsklinikum Hamburg Eppendorf
Hamburg
Prof. Frey Praxis Starnberg
Starnberg

Other trials in Germany

Greece1 site

Onassis Cardiac Surgery Center
Athens

Other trials in Greece

About this study

Official title: Ventricular Arrhythmias Incidence According to Sleep Apnea Syndrome in ICD Patients

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.

Conditions: Sleep Apnoea
Being tested: ICD, CRT-D
Medical subject headings: Sleep Apnea Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ICDDevice
Ventricular arrhythmia treatment
CRT-DDevice
Ventricular arrhythmia treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 12 months
To report and compare the number of hospitalizations, mortality, and morbidity according to Respiratory Disturbance Index (RDI).
Measured: 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
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2004Oct 2007

First posted2 Jul 2008 (estimated)
Study startApr 2004
Primary completionOct 2007
Study completionOct 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Sleep ApnoeaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 755 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00708786
Sponsor's protocol ID: ITAC01-VISION
Status last verified: Jun 2008
First submitted: 7 Apr 2008
Last updated: 2 Jul 2008
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders

All Sleep Apnoea trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ventricular Arrhythmias Incidence According to Sleep Apnea Syndrome in ICD Patients
ClinicalTrials.gov ID: NCT00708786
Acronym / sponsor ID: ITAC01-VISION
Conditions: Sleep Apnoea
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 755 participants (estimated)
Lead sponsor: LivaNovaIndustry (pharma, biotech, devices)
Study start: Apr 2004
Primary completion: Oct 2007 (actual)
Study completion: Oct 2007 (actual)
First posted: 2 Jul 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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
Class IIa Indication for ICD
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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ICDVentricular arrhythmia treatment	Device	–
CRT-DVentricular arrhythmia treatment	Device	–

Primary outcome

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

3 secondary outcomes

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
To report and compare the number of hospitalizations, mortality, and morbidity according to Respiratory Disturbance Index (RDI).
Time frame: 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
Time frame: 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2008.

Related trials for Sleep Apnoea

RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Frédéric Anselme, MD principal investigator

CHU Charles Nicolle - Rouen

31 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ICD and CRT-D in people with Sleep Apnoea, run by LivaNova at 31 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in France, Italy, Germany, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00708786.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2008.