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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01058551
First Posted: January 28, 2010
Last Update Posted: February 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic
Information provided by (Responsible Party):
Dr. Adrian Baranchuk, Queen's University
  Purpose
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: None (Open Label)
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

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01058551


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

Publications:
Responsible Party: Dr. Adrian Baranchuk, MD, Queen's University
ClinicalTrials.gov Identifier: NCT01058551     History of Changes
Other Study ID Numbers: Reveal XT-SA
First Submitted: January 27, 2010
First Posted: January 28, 2010
Last Update Posted: February 24, 2017
Last Verified: February 2017

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

Additional relevant MeSH terms:
Atrial Fibrillation
Apnea
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
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases