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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 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: August 13, 2013
Last verified: August 2013
  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:


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 2016
Estimated Primary Completion Date: July 2015 (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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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: August 13, 2013
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 July 20, 2014