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

This study is currently recruiting participants.

Verified March 2012 by Queen's University

Sponsor:

Collaborator:

Medtronic

Information provided by (Responsible Party):

Adrian Baranchuk, Queen's University

ClinicalTrials.gov Identifier:

NCT01058551

First received: January 27, 2010

Last updated: March 27, 2012

Last verified: March 2012

History of Changes

Purpose

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.

Condition	Intervention
Obstructive Sleep Apnea Atrial Fibrillation	Device: Implantable Loop Recorder Insertion

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Incidence of New Onset Atrial Fibrillation in Patients With Severe Obstructive Sleep Apnea: The Reveal XT-SA Study

Resource links provided by NLM:

Genetics Home Reference related topics: familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation Sleep Apnea

U.S. FDA Resources

Further study details as provided by Queen's University:

Primary Outcome Measures:

To determine the incidence of new onset AF in patient's with severe OSA [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	June 2011
Estimated Study Completion Date:	August 2014
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Reveal XT ILR Implantable Loop Recorder Insertion	Device: Implantable Loop Recorder Insertion Implantable Loop Recorder Insertion. The device will be explanted after reaching outcome (First AF detected) or at 36 months Other Name: Reveal XT ILR, Medtronic

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with severe OSA defined as Apnea Hypopnea Index (AHI) > 30.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01058551

Contacts

Contact: Adrian M Baranchuk, MD

(613) 549-6666 ext 3801

barancha@kgh.kari.net

Locations

Canada, Ontario
Kingston General Hospital	Recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Sharlene Hammond, RN (613) 549-6666 ext 32148 hammons1@kgh.kari.net
Sub-Investigator: Michael Fitzpatrick, MD
Sub-Investigator: Christopher Simpson, MD
Sub-Investigator: Damian P Redfearn, MD
Sub-Investigator: Kevin A Michael, MD
Sub-Investigator: Juan C Lopez Diez, MD
Sub-Investigator: Rodrigo Miranda`, MD
Sub-Investigator: Hoshiar Abdollah, MD

Sponsors and Collaborators

Queen's University

Medtronic

Investigators

Principal Investigator:

Adrian Baranchuk, MD

Queen's University

More Information

Publications:

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. Epub 2008 Apr 7. Review. No abstract available.

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. Epub 2003 May 12.

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. Epub 2004 Jul 12.

Responsible Party:	Adrian Baranchuk, MD, Queen's University
ClinicalTrials.gov Identifier:	NCT01058551 History of Changes
Other Study ID Numbers:	Reveal XT-SA
Study First Received:	January 27, 2010
Last Updated:	March 27, 2012
Health Authority:	Canada: Health Canada

Keywords provided by Queen's University:

Sleep Apnea
Atrial Fibrillation

Additional relevant MeSH terms:

Apnea
Atrial Fibrillation
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013

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