Obstructive Sleep ApneaNCT01058551
Incidence of Atrial Fibrillation in Patients With Severe Obstructive Sleep Apnea: The Reveal XT-SA Study
A study testing Implantable Loop Recorder Insertion in people with Obstructive Sleep Apnea and Atrial Fibrillation, run by Dr. Adrian Baranchuk at 1 site in Canada.
Trial summary
Single site study: The goal of the study is to determine the incidence of new onset atrial fibrillation (AF) in patients with severe obstructive sleep apnea (OSA) syndrome through the use of a Medtronic Reveal XT implantable Loop recorder (ILR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Atrial Fibrillation
- What is being tested?
- Implantable Loop Recorder Insertion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2011to 18 Sep 2019
- Phase
- Interventional
- 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 with severe OSA defined as Apnea Hypopnea Index (AHI) > 30.
- Age > 18 years.
Who cannot join
- Previous history of clinical AF defined as documented lone, paroxysmal, persistent or permanent, according to standard definitions.
- Patient with anticipated requirement of MRI.
- Patient with well-know allergy to any component of the Medtronic Reveal XT.
- Patients with implantable cardiac rhythm device [pacemakers or internal cardiac device (ICDs)].
- Women of child bearing potential.
- Unable or unwilling to provide written informed consent.
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- Unable or unwilling to complete the study follow-up schedule (eg. intention to leave the Kingston area over the next 3 years.
- Previously enrolled in this trial.
- Enrolled in another study that would confound the results of this trial.
- Documented history of heart failure
- Diagnosed with severe obstructive sleep apnea greater than 1 year from screening date
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of New Onset Atrial Fibrillation in Patients With Severe Obstructive Sleep Apnea: The Reveal XT-SA Study
Single site study: The goal of the study is to determine the incidence of new onset atrial fibrillation (AF) in patients with severe obstructive sleep apnea (OSA) syndrome through the use of a Medtronic Reveal XT implantable Loop recorder (ILR). The ILR device is approved for use in Canada, for the assessment of atrial fibrillation.
- Conditions
- Obstructive Sleep Apnea, Atrial Fibrillation
- Being tested
- Implantable Loop Recorder Insertion
- Keywords
- Sleep Apnea, Atrial Fibrillation
- Medical subject headings
- Sleep Apnea, Obstructive, Atrial Fibrillation, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable Loop Recorder InsertionDevice
Also called Reveal XT ILR, Medtronic
Implantable Loop Recorder Insertion. The device will be explanted after reaching outcome (First AF detected) or at 36 months
| Study group | Role | What they receive |
|---|---|---|
| Reveal XT ILR | Experimental | Implantable Loop Recorder Insertion Receives: Device: Implantable Loop Recorder Insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the incidence of new onset AF in patient's with severe OSA
Measured: 36 months
Secondary outcomes (1)
To determine the impact of continuous positive airway pressure (CPAP) treatment in patients with new onset of AF in patients with severe OSA. (post hoc analysis)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2010 (estimated)
- Study startJun 2011
- Primary completion10 Sep 2019
- Study completion18 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Adrian Baranchuk
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor-investigator, Dr. Adrian Baranchuk, Queen's University
- Investigators
- Adrian Baranchuk, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058551
- Sponsor's protocol ID
- Reveal XT-SA
- Status last verified
- Apr 2024
- First submitted
- 27 Jan 2010
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Baranchuk A, Simpson CS, Redfearn DP, Fitzpatrick M. It's time to wake up! Sleep apnea and cardiac arrhythmias. Europace. 2008 Jun;10(6):666-7. doi: 10.1093/europace/eun078. Epub 2008 Apr 7. No abstract available.
PubMed 18390984Kanagala R, Murali NS, Friedman PA, Ammash NM, Gersh BJ, Ballman KV, Shamsuzzaman AS, Somers VK. Obstructive sleep apnea and the recurrence of atrial fibrillation. Circulation. 2003 May 27;107(20):2589-94. doi: 10.1161/01.CIR.0000068337.25994.21. Epub 2003 May 12.
PubMed 12743002Gami AS, Pressman G, Caples SM, Kanagala R, Gard JJ, Davison DE, Malouf JF, Ammash NM, Friedman PA, Somers VK. Association of atrial fibrillation and obstructive sleep apnea. Circulation. 2004 Jul 27;110(4):364-7. doi: 10.1161/01.CIR.0000136587.68725.8E. Epub 2004 Jul 12.
PubMed 15249509Yeung C, Drew D, Hammond S, Hopman WM, Redfearn D, Simpson C, Abdollah H, Baranchuk A. Extended Cardiac Monitoring in Patients With Severe Sleep Apnea and No History of Atrial Fibrillation (The Reveal XT-SA Study). Am J Cardiol. 2018 Dec 1;122(11):1885-1889. doi: 10.1016/j.amjcard.2018.08.032. Epub 2018 Sep 7.
PubMed 30274768
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of New Onset Atrial Fibrillation in Patients With Severe Obstructive Sleep Apnea: The Reveal XT-SA Study
- ClinicalTrials.gov ID
- NCT01058551
- Acronym / sponsor ID
- Reveal XT-SA
- Conditions
- Obstructive Sleep Apnea, Atrial Fibrillation
- Keywords
- Sleep Apnea, Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Dr. Adrian BaranchukUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Jun 2011
- Primary completion
- 10 Sep 2019 (actual)
- Study completion
- 18 Sep 2019 (actual)
- First posted
- 28 Jan 2010 (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.
Single site study: The goal of the study is to determine the incidence of new onset atrial fibrillation (AF) in patients with severe obstructive sleep apnea (OSA) syndrome through the use of a Medtronic Reveal XT implantable Loop recorder (ILR). The ILR device is approved for use in Canada, for the assessment of atrial fibrillation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reveal XT ILR | Experimental | Device: Implantable Loop Recorder InsertionImplantable Loop Recorder Insertion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with severe OSA defined as Apnea Hypopnea Index (AHI) > 30.
- Age > 18 years.
Key exclusion criteria (11 listed)
- Previous history of clinical AF defined as documented lone, paroxysmal, persistent or permanent, according to standard definitions.
- Patient with anticipated requirement of MRI.
- Patient with well-know allergy to any component of the Medtronic Reveal XT.
- Patients with implantable cardiac rhythm device [pacemakers or internal cardiac device (ICDs)].
- Women of child bearing potential.
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 |
|---|---|---|
| Implantable Loop Recorder InsertionAlso: Reveal XT ILR, MedtronicImplantable Loop Recorder Insertion. The device will be explanted after reaching outcome (First AF detected) or at 36 months | Device | Reveal XT ILR |
Primary outcome
To determine the incidence of new onset AF in patient's with severe OSA
Time frame: 36 months
1 secondary outcome
To determine the impact of continuous positive airway pressure (CPAP) treatment in patients with new onset of AF in patients with severe OSA. (post hoc analysis)
Time frame: 36 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 15 Apr 2024.
- Background: PubMed 18390984Baranchuk A, Simpson CS, Redfearn DP, Fitzpatrick M. It's time to wake up! Sleep apnea and cardiac arrhythmias. Europace. 2008 Jun;10(6):666-7. doi: 10.1093/europace/eun078. Epub 2008 Apr 7. No abstract available.
- Background: PubMed 12743002Kanagala R, Murali NS, Friedman PA, Ammash NM, Gersh BJ, Ballman KV, Shamsuzzaman AS, Somers VK. Obstructive sleep apnea and the recurrence of atrial fibrillation. Circulation. 2003 May 27;107(20):2589-94. doi: 10.1161/01.CIR.0000068337.25994.21. Epub 2003 May 12.
- Background: PubMed 15249509Gami AS, Pressman G, Caples SM, Kanagala R, Gard JJ, Davison DE, Malouf JF, Ammash NM, Friedman PA, Somers VK. Association of atrial fibrillation and obstructive sleep apnea. Circulation. 2004 Jul 27;110(4):364-7. doi: 10.1161/01.CIR.0000136587.68725.8E. Epub 2004 Jul 12.
- Derived from this study: PubMed 30274768Yeung C, Drew D, Hammond S, Hopman WM, Redfearn D, Simpson C, Abdollah H, Baranchuk A. Extended Cardiac Monitoring in Patients With Severe Sleep Apnea and No History of Atrial Fibrillation (The Reveal XT-SA Study). Am J Cardiol. 2018 Dec 1;122(11):1885-1889. doi: 10.1016/j.amjcard.2018.08.032. Epub 2018 Sep 7.
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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.
Adrian Baranchuk, MD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantable Loop Recorder Insertion in people with Obstructive Sleep Apnea and Atrial Fibrillation, run by Dr. Adrian Baranchuk at 1 site in Canada.
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 2 inclusion and 11 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 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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.
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?
To determine the incidence of new onset AF in patient's with severe OSA (time frame: 36 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 NCT01058551, which also lists 4 linked publications.
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 15 Apr 2024.