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

Primary Purpose

Obstructive Sleep Apnea, Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Implantable Loop Recorder Insertion
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obstructive Sleep Apnea focused on measuring Sleep Apnea, Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kingston General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Reveal XT ILR

Arm Description

Implantable Loop Recorder Insertion

Outcomes

Primary Outcome Measures

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

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)

Full Information

First Posted
January 27, 2010
Last Updated
November 26, 2019
Sponsor
Queen's University
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT01058551
Brief Title
Incidence of Atrial Fibrillation in Patients With Severe Obstructive Sleep Apnea: The Reveal XT-SA Study
Official Title
Incidence of New Onset Atrial Fibrillation in Patients With Severe Obstructive Sleep Apnea: The Reveal XT-SA Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
September 10, 2019 (Actual)
Study Completion Date
September 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Atrial Fibrillation
Keywords
Sleep Apnea, Atrial Fibrillation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reveal XT ILR
Arm Type
Experimental
Arm Description
Implantable Loop Recorder Insertion
Intervention Type
Device
Intervention Name(s)
Implantable Loop Recorder Insertion
Other Intervention Name(s)
Reveal XT ILR, Medtronic
Intervention Description
Implantable Loop Recorder Insertion. The device will be explanted after reaching outcome (First AF detected) or at 36 months
Primary Outcome Measure Information:
Title
To determine the incidence of new onset AF in patient's with severe OSA
Time Frame
36 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with severe OSA defined as Apnea Hypopnea Index (AHI) > 30. Age > 18 years. Exclusion Criteria: 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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Baranchuk, MD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
18390984
Citation
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.
Results Reference
background
PubMed Identifier
12743002
Citation
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.
Results Reference
background
PubMed Identifier
15249509
Citation
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.
Results Reference
background
PubMed Identifier
30274768
Citation
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.
Results Reference
derived

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

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