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Completed

NCT Number: NCT01058551

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Documented history of heart failure
  • Diagnosed with severe obstructive sleep apnea greater than 1 year from screening date

Treatment and study plan

implantable loop recorder insertion

Device

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

Other names: Reveal XT ILR, Medtronic

Primary outcomes

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

    Time frame: 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)

    Time frame: 36 months

Sponsors and collaborators

Lead sponsor

Dr. Adrian Baranchuk

Other

Collaborators

  • Medtronic

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Jan 28, 2010
Registry last updated
Apr 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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