Incidence of Atrial Fibrillation in Patients With Severe Obstructive Sleep Apnea: The Reveal XT-SA Study
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|ClinicalTrials.gov Identifier: NCT01058551|
Recruitment Status : Completed
First Posted : January 28, 2010
Last Update Posted : November 27, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea Atrial Fibrillation||Device: Implantable Loop Recorder Insertion||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- To determine the incidence of new onset AF in patient's with severe OSA [ Time Frame: 36 months ]
- 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 ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients with severe OSA defined as Apnea Hypopnea Index (AHI) > 30.
- Age > 18 years.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01058551
|Kingston General Hospital|
|Kingston, Ontario, Canada, K7L 2V7|
|Principal Investigator:||Adrian Baranchuk, MD||Queen's University|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Dr. Adrian Baranchuk, MD, Queen's University|
|Other Study ID Numbers:||
|First Posted:||January 28, 2010 Key Record Dates|
|Last Update Posted:||November 27, 2019|
|Last Verified:||November 2019|
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases