View Clinical Trial (Medical Research Study)
Atrial Fibrillation Recurrence in Sleep Apnea - NCT00263757-55905(Clinical Trial 379666)
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| City: |
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Rochester |
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State:
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MN |
| Zip Code: |
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55905 |
| Conditions: |
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Sleep Apnea - Atrial Fibrillation |
| Purpose: |
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The purpose of the study is to determine if, in people with sleep apnea who have undergone
cardioversion therapy for atrial fibrillation, the recurrence rate of atrial fibrillation is
affected by sleep apnea treatment.
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| Study summary: |
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sleep apnea is a common disorder which is increasingly implicated in the pathogenesis of
cardiovascular disease. Observational data suggest that sleep apnea may play a role in the
development of atrial fibrillation (AF), and may even predispose to recurrence of AF
following electrical cardioversion (DCCV). Because of biases and confounders inherent to
observational studies, we propose a randomized clinical trial to assess the effects of
treatment of sleep apnea in subjects with AF treated with DCCV. Following polysomnography,
subjects with sleep apnea will be randomized to positive airway pressure (PAP) or usual
medical care and followed for up to one year to compare a primary outcome of AF recurrence
rate. |
| Criteria: |
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Inclusion criteria:
1. Age >18 yrs
2. Successful electrical or chemical cardioversion within previous 2 weeks
3. Greater than 2 episodes symptomatic AF in previous 6 months
Exclusion criteria:
1. Currently on PAP therapy
2. Moderate to severe pulmonary disease
3. Neurologic impairment (h/o CVA, TIA, neuromuscular disease, diaphragmatic paralysis)
4. Severe cardiac disease (LVEF<40%, greater than mild to moderate valvular disease)
5. Post cardiac surgery AF
6. Congenital heart disease
7. Renal disease (Scr > 2.5)
8. Excessive EtOH use (>2 drinks/day)
9. Anatomically fixed nasal obstruction (severe septal deviation, uncontrolled rhinitis)
10. History of motor vehicle or occupational accident related to sleepiness.
11. Epworth Sleepiness Scale score >18 (out of maximum score of 24). |
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| Study is available at: |
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Mayo Clinic
Rochester, MN 55905
United States
Primary Contact:
Lindsey L Haagensen
Email: haagensen.lindsey@mayo.edu
Phone: 507-255-1997 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 21, 2011 |
Modifications to
this listing: |
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above to view all information about this clinical trial. |
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