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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Dr. Adrian Baranchuk, Queen's University Identifier:
First received: January 27, 2010
Last updated: February 23, 2017
Last verified: February 2017
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.

Condition Intervention
Obstructive Sleep Apnea
Atrial Fibrillation
Device: Implantable Loop Recorder Insertion

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic
Official Title: Incidence of New Onset Atrial Fibrillation in Patients With Severe Obstructive Sleep Apnea: The Reveal XT-SA Study

Resource links provided by NLM:

Further study details as provided by Dr. Adrian Baranchuk, Queen's University:

Primary Outcome Measures:
  • To determine the incidence of new onset AF in patient's with severe OSA [ Time Frame: 36 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 31
Study Start Date: June 2011
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reveal XT ILR
Implantable Loop Recorder Insertion
Device: Implantable Loop Recorder Insertion
Implantable Loop Recorder Insertion. The device will be explanted after reaching outcome (First AF detected) or at 36 months
Other Name: Reveal XT ILR, Medtronic


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

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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Please refer to this study by its identifier: NCT01058551

Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Sponsors and Collaborators
Queen's University
Principal Investigator: Adrian Baranchuk, MD Queen's University
  More Information

Responsible Party: Dr. Adrian Baranchuk, MD, Queen's University Identifier: NCT01058551     History of Changes
Other Study ID Numbers: Reveal XT-SA
Study First Received: January 27, 2010
Last Updated: February 23, 2017

Keywords provided by Dr. Adrian Baranchuk, Queen's University:
Sleep Apnea
Atrial Fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases processed this record on May 25, 2017