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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea; Atrial Fibrillation
• Interventions: Device: Implantable Loop Recorder Insertion

• Registration Number: NCT01058551
• Lead Sponsor: Dr. Adrian Baranchuk

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-27
• Study First Submitted QC: 2010-01-27
• Study First Posted: 2010-01-28
• Study Start: 2011-06
• Primary Completion: 2019-09-10
• Study Completion: 2019-09-18
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Reveal XT ILR	Implantable Loop Recorder Insertion	Implantable Loop Recorder Insertion

Primary Outcome Measures

Name	Time	Method
To determine the incidence of new onset AF in patient's with severe OSA	36 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada