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

Study Overview
=================
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.

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

Conditions
-----------------
Obstructive Sleep Apnea, Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: Implantable Loop Recorder Insertion


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reveal XT ILR<br>Implantable Loop Recorder Insertion | Device: Implantable Loop Recorder Insertion<br>* Implantable Loop Recorder Insertion. The device will be explanted after reaching outcome (First AF detected) or at 36 months<br>* Other names: Reveal XT ILR, Medtronic;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the incidence of new onset AF in patient's with severe OSA |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep Apnea, Atrial Fibrillation