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
Male or female participants at least 18 years old.
- Patients with severe OSA defined as Apnea Hypopnea Index (AHI) > 30.
- Age > 18 years.
- 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
|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|
Call for more information