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

NCT ID: NCT01058551

Last Updated: 2024-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2019-09-18

Brief Summary

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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

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Conditions

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Obstructive Sleep Apnea Atrial Fibrillation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Reveal XT ILR

Implantable Loop Recorder Insertion

Group Type EXPERIMENTAL

Implantable Loop Recorder Insertion

Intervention Type DEVICE

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

Interventions

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Implantable Loop Recorder Insertion

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

Intervention Type DEVICE

Other Intervention Names

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Reveal XT ILR, Medtronic

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Dr. Adrian Baranchuk

OTHER

Sponsor Role lead

Responsible Party

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Dr. Adrian Baranchuk

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Adrian Baranchuk, MD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

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Kingston General Hospital

Kingston, Ontario, Canada

Site Status

Countries

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Canada

References

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Baranchuk A, Simpson CS, Redfearn DP, Fitzpatrick M. It's time to wake up! Sleep apnea and cardiac arrhythmias. Europace. 2008 Jun;10(6):666-7. doi: 10.1093/europace/eun078. Epub 2008 Apr 7. No abstract available.

Reference Type BACKGROUND
PMID: 18390984 (View on PubMed)

Kanagala R, Murali NS, Friedman PA, Ammash NM, Gersh BJ, Ballman KV, Shamsuzzaman AS, Somers VK. Obstructive sleep apnea and the recurrence of atrial fibrillation. Circulation. 2003 May 27;107(20):2589-94. doi: 10.1161/01.CIR.0000068337.25994.21. Epub 2003 May 12.

Reference Type BACKGROUND
PMID: 12743002 (View on PubMed)

Gami AS, Pressman G, Caples SM, Kanagala R, Gard JJ, Davison DE, Malouf JF, Ammash NM, Friedman PA, Somers VK. Association of atrial fibrillation and obstructive sleep apnea. Circulation. 2004 Jul 27;110(4):364-7. doi: 10.1161/01.CIR.0000136587.68725.8E. Epub 2004 Jul 12.

Reference Type BACKGROUND
PMID: 15249509 (View on PubMed)

Yeung C, Drew D, Hammond S, Hopman WM, Redfearn D, Simpson C, Abdollah H, Baranchuk A. Extended Cardiac Monitoring in Patients With Severe Sleep Apnea and No History of Atrial Fibrillation (The Reveal XT-SA Study). Am J Cardiol. 2018 Dec 1;122(11):1885-1889. doi: 10.1016/j.amjcard.2018.08.032. Epub 2018 Sep 7.

Reference Type DERIVED
PMID: 30274768 (View on PubMed)

Other Identifiers

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Reveal XT-SA

Identifier Type: -

Identifier Source: org_study_id

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