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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reveal XT ILR | Experimental | Implantable Loop Recorder Insertion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantable Loop Recorder Insertion | Device | Implantable Loop Recorder Insertion. The device will be explanted after reaching outcome (First AF detected) or at 36 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the incidence of new onset AF in patient's with severe OSA | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrian Baranchuk, MD | Queen's University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kingston General Hospital | Kingston | Ontario | K7L 2V7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18390984 | Background | 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. | |
| 12743002 | Background | 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. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D001281 | Atrial Fibrillation |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| 15249509 | Background | 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. |
| 30274768 | Derived | 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. |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |