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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01058551
• Other study ID #: Reveal XT-SA
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: September 18, 2019

Study information

• Verified date: April 2024
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 18, 2019
• Est. primary completion date: September 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Atrial Fibrillation
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
Canada	Kingston General Hospital	Kingston	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Adrian Baranchuk	Medtronic

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the incidence of new onset AF in patient's with severe OSA		36 months
Secondary	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