Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Queen's University
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Adrian Baranchuk, Queen's University
ClinicalTrials.gov Identifier:
NCT01058551
First received: January 27, 2010
Last updated: August 13, 2013
Last verified: August 2013

January 27, 2010
August 13, 2013
June 2011
July 2015   (final data collection date for primary outcome measure)
To determine the incidence of new onset AF in patient's with severe OSA [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01058551 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Incidence of Atrial Fibrillation in Patients With Severe Obstructive Sleep Apnea: The Reveal XT-SA Study
Incidence of New Onset Atrial Fibrillation in Patients With Severe Obstructive Sleep Apnea: The Reveal XT-SA 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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Obstructive Sleep Apnea
  • Atrial Fibrillation
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
Experimental: Reveal XT ILR
Implantable Loop Recorder Insertion
Intervention: Device: Implantable Loop Recorder Insertion

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
August 2016
July 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Adrian M Baranchuk, MD (613) 549-6666 ext 3801 barancha@kgh.kari.net
Canada
 
NCT01058551
Reveal XT-SA
No
Adrian Baranchuk, Queen's University
Queen's University
Medtronic
Principal Investigator: Adrian Baranchuk, MD Queen's University
Queen's University
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP