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 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT02389218
Eligibility Criteria:
Inclusion Criteria:
* \> 21 years and legally capable
* First documentation or history of symptomatic AF more than 30 sec within the last 2 years
* Twice AF within the last year
* One episode cardioverted after more than 48 hours or spontaneously terminated after more than 7 days
* Eligible for at least one first step drug therapy (sotalol, propafenone, or flecainide) and for amiodarone
* Left ventricular ejection fraction estimated \> 45%
* LA diameter \< 50 mm (parasternal short axis) and LA volume less than 100 ml (apical view, Area Length method;)
* CHADS2 ≤ 2
* Failed AAD strategy, or untreated with AAD
* No use of Amiodarone in the previous 3 months (except IV or oral for 7 days)
* Informed consent
Exclusion Criteria:
* Age \> 75 yrs
* CHF
* Ischemic heart disease as known in the history
* (Severe) Left ventricular hypertrophy as shown on echo (IVSd or PWd \> 14 mm)
* Hyperthyroidism
* Congenital heart disease
* Hypertrophic Cardiomyopathy, Arrhythmogenic Right ventricular Cardiomyopathy, channelopathies
* Contra-indications to AAD
* Long QT syndrome
* Received already adequately dosed all level 1 drugs (sotalol, propafenone, and flecainide)
* Pure (typical) atrial flutter as documented on one occasion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT02389218
Study Brief:
Protocol Section:
NCT02389218