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:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT02955004
Eligibility Criteria:
Inclusion Criteria:
Atrial fibrillation of recent onset (less than 48 hours) ongoing at time for baseline MRI.
Age: 18-75 years
Exclusion Criteria:
1. Recent (less than 3 months) cardioversion of AF or atrial flutter
2. Previous clinical cerebrovascular event
3. Congestive heart failure New York Heart Association (NYHA) function class III and IV
4. Previously documented moderate or severely decreased left ventricular ejection fraction (LVEF less than 35%)
5. Previously documented marked mitral regurgitation or stenosis
6. Atrial flutter, atypical atrial flutter or intra-atrial re-entry tachycardia
7. Contraindications to electrical cardioversion
8. Permanent implanted cardiac device (event recorders accepted)
9. Contraindication to nuclear magnetic resonance imaging (MRI) - see separate list addendum 1.
10. Known coagulation defects or spontaneous INR or activated partial thromboplastin time (APTT) levels at therapeutic levels
11. Current Vitamin K antagonists (VKA) or Novel Oral Anticoagulation (NOAC) treatment
12. Spontaneous conversion to sinus rhythm prior to first MRI
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02955004
Study Brief:
Protocol Section:
NCT02955004