Incidence of Atrial Fibrillation in Patients With Severe Obstructive Sleep Apnea: The Reveal XT-SA Study
This trial is active, not recruiting.
|Conditions||obstructive sleep apnea, atrial fibrillation|
|Treatment||implantable loop recorder insertion|
|Start date||June 2011|
|End date||July 2019|
|Trial size||31 participants|
|Trial identifier||NCT01058551, Reveal XT-SA|
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.
|Intervention model||single group assignment|
Implantable Loop Recorder Insertion
To determine the incidence of new onset AF in patient's with severe OSA
time frame: 36 months
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
All participants at least 18 years old.
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
|Official title||Incidence of New Onset Atrial Fibrillation in Patients With Severe Obstructive Sleep Apnea: The Reveal XT-SA Study|
|Principal investigator||Adrian Baranchuk, MD|
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