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CompletedNCT01058551Updated Apr 15, 2024

Incidence of Atrial Fibrillation in Patients With Severe Obstructive Sleep Apnea: The Reveal XT-SA Study

An interventional study of Implantable Loop Recorder Insertion in Obstructive Sleep Apnea and Atrial Fibrillation, sponsored by Dr. Adrian Baranchuk. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-15.

Sponsored by Dr. Adrian Baranchuk · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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). The ILR device is approved for use in Canada, for the assessment of atrial fibrillation.

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Conditions studied

  • Obstructive Sleep Apnea
  • Atrial Fibrillation

Keywords

  • Sleep Apnea
  • Atrial Fibrillation
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In context

Sleep Apnea, Obstructive

2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.

This study's enrollment of 31 is below the median of 53 across 1,490 interventional studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

This is the only study on the registry with Dr. Adrian Baranchuk as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients with severe OSA defined as Apnea Hypopnea Index (AHI) > 30.
  2. Age > 18 years.

Exclusion criteria

Exclusion Criteria:

  1. Previous history of clinical AF defined as documented lone, paroxysmal, persistent or permanent, according to standard definitions.
  2. Patient with anticipated requirement of MRI.
  3. Patient with well-know allergy to any component of the Medtronic Reveal XT.
  4. Patients with implantable cardiac rhythm device [pacemakers or internal cardiac device (ICDs)].
  5. Women of child bearing potential.
  6. Unable or unwilling to provide written informed consent.
  7. Unable or unwilling to complete the study follow-up schedule (eg. intention to leave the Kingston area over the next 3 years.
  8. Previously enrolled in this trial.
  9. Enrolled in another study that would confound the results of this trial.
  10. Documented history of heart failure
  11. Diagnosed with severe obstructive sleep apnea greater than 1 year from screening date
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    Reveal XT ILR

    Implantable Loop Recorder Insertion

    Device: Implantable Loop Recorder Insertion

Interventions

  • DeviceImplantable Loop Recorder Insertion

    Implantable Loop Recorder Insertion. The device will be explanted after reaching outcome (First AF detected) or at 36 months

    Also known as: Reveal XT ILR, Medtronic

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What researchers measure

Primary outcomes

  1. To determine the incidence of new onset AF in patient's with severe OSA

    Time frame: 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)

    Time frame: 36 months

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Study locations

1 site
  • Kingston General Hospital
    Kingston, Ontario K7L 2V7, Canada
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References and documents

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 18390984 ↗
  • Kanagala 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 12743002 ↗
  • Gami 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 15249509 ↗
  • Yeung 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01058551
Lead sponsor
Dr. Adrian Baranchuk
Collaborators
Medtronic
Responsible party
Dr. Adrian Baranchuk (MD, Queen's University) — Sponsor-investigator
First posted
Jan 28, 2010
Start date
Jun 2011
Primary completion
Sep 10, 2019
Completion
Sep 18, 2019
Last update
Apr 15, 2024

Study contacts

Adrian Baranchuk, MD
principal investigator · Queen's University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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