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

Dr. Adrian Baranchuk1 site in 1 country31 target enrollmentJune 2011

ConditionsObstructive Sleep Apnea Atrial Fibrillation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Obstructive Sleep Apnea
Sponsor: Dr. Adrian Baranchuk
Enrollment: 31
Locations: 1
Primary Endpoint: To determine the incidence of new onset AF in patient's with severe OSA
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2011

End Date

September 18, 2019

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Dr. Adrian Baranchuk

Responsible Party

Sponsor Investigator

Principal Investigator

Dr. Adrian Baranchuk

Queen's University

Eligibility Criteria

Inclusion Criteria

•Patients with severe OSA defined as Apnea Hypopnea Index (AHI) \>
•Age \> 18 years.

Exclusion Criteria

•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

Outcomes

Primary Outcomes

To determine the incidence of new onset AF in patient's with severe OSA

Time Frame: 36 months

Secondary Outcomes

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)