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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01058551

Enrollment

Registered

2010-01-28

Start date

2011-06-30

Completion date

2019-09-18

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Obstructive Sleep Apnea

Keywords

Sleep Apnea, Atrial Fibrillation

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.

Interventions

DEVICEImplantable Loop Recorder Insertion

Implantable Loop Recorder Insertion. The device will be explanted after reaching outcome (First AF detected) or at 36 months

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026