NCT01058551

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2010

Completed
1.3 years until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2019

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2019

Completed
Last Updated

April 15, 2024

Status Verified

April 1, 2024

Enrollment Period

8.3 years

First QC Date

January 27, 2010

Last Update Submit

April 11, 2024

Conditions

Obstructive Sleep ApneaAtrial Fibrillation

Keywords

Sleep ApneaAtrial Fibrillation

Outcome Measures

Primary Outcomes (1)

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

    36 months

Secondary Outcomes (1)

  • 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

Study Arms (1)

Reveal XT ILR

EXPERIMENTAL

Implantable Loop Recorder Insertion

Device: Implantable Loop Recorder Insertion

Interventions

Implantable Loop Recorder InsertionDEVICE

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

Also known as: Reveal XT ILR, Medtronic
Reveal XT ILR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with severe OSA defined as Apnea Hypopnea Index (AHI) \> 30.
  • Age \> 18 years.

You may not qualify if:

  • 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
  • Diagnosed with severe obstructive sleep apnea greater than 1 year from screening date

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

Related Publications (4)

  • 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.

    PMID: 18390984BACKGROUND

  • 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.

    PMID: 12743002BACKGROUND

  • 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.

    PMID: 15249509BACKGROUND

  • 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.

    PMID: 30274768DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveAtrial FibrillationSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Adrian Baranchuk, MD

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 27, 2010

First Posted

January 28, 2010

Study Start

June 1, 2011

Primary Completion

September 10, 2019

Study Completion

September 18, 2019

Last Updated

April 15, 2024

Record last verified: 2024-04

Locations

CA(1)