Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT02743520
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of OSA within the last 12 months
2. No previous diagnosis of atrial fibrillation
3. Able and willing to follow-up as an outpatient
4. Age 40-85 years
Exclusion Criteria:
1. Life expectancy \< 2 years
2. Dementia or other neurologic condition which would make outpatient follow-up difficult
3. CHADS score \<2
4. Alcohol or drug abuse which would interfere with outpatient follow-up
5. Severe Congestive heart failure (NYHA class 3 or 4) or use of left ventricular assist device.
6. Current dialysis treatment or planned treatment within 12 months
7. Known bleeding disorder or prothrombin time \>15 seconds
8. Mechanical heart valve requiring anticoagulation
9. Moderate to severe mitral stenosis or regurgitation
10. Prior clinical diagnosis of ischemic stroke (radiologic infarcts are not excluded)
11. Chronic obstructive pulmonary disease with oxygen dependence
12. Pregnant patients or patients that plan to become pregnant within the course of the study\*.
13. Patients with anticipated need for a pacemaker during the course of the study \*If any patients become pregnant during the course of the study, pregnancy outcomes will not be followed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
85 Years
Study:
NCT02743520
Study Brief:
Protocol Section:
NCT02743520