Overview

This trial is active, not recruiting.

Conditions obstructive sleep apnea, atrial fibrillation
Treatment implantable loop recorder insertion
Sponsor Queen's University
Collaborator Medtronic
Start date June 2011
End date July 2019
Trial size 31 participants
Trial identifier NCT01058551, Reveal XT-SA

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Implantable Loop Recorder Insertion
implantable loop recorder insertion Reveal XT ILR, Medtronic
Implantable Loop Recorder Insertion. The device will be explanted after reaching outcome (First AF detected) or at 36 months

Primary Outcomes

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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female 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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Queen's University.