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

• ClinicalTrials.gov Identifier: NCT01058551
• Recruitment Status: Completed
• First Posted: January 28, 2010
• Last Update Posted: November 27, 2019
• Sponsor: Queen's University
• Collaborator: Medtronic
• Information provided by (Responsible Party): Dr. Adrian Baranchuk, Queen's University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Obstructive Sleep Apnea; Atrial Fibrillation	Device: Implantable Loop Recorder Insertion	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 31 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: June 2011
• Actual Primary Completion Date: September 10, 2019
• Actual Study Completion Date: September 18, 2019

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. To determine the incidence of new onset AF in patient's with severe OSA [ Time Frame: 36 months ]

Secondary Outcome Measures :

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) [ Time Frame: 36 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Canada, Ontario

Kingston General Hospital

Kingston, Ontario, Canada, K7L 2V7

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. doi: 10.1093/europace/eun078. Epub 2008 Apr 7. 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. doi: 10.1161/01.CIR.0000068337.25994.21. 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. doi: 10.1161/01.CIR.0000136587.68725.8E. Epub 2004 Jul 12.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Dr. Adrian Baranchuk, MD, Queen's University
• ClinicalTrials.gov Identifier: NCT01058551
• Other Study ID Numbers: Reveal XT-SA
• First Posted: January 28, 2010
• Last Update Posted: November 27, 2019
• Last Verified: November 2019

Keywords provided by Dr. Adrian Baranchuk, Queen's University:

Sleep Apnea; Atrial Fibrillation

Additional relevant MeSH terms:

Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases