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 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
NCT ID:
NCT01213368
Eligibility Criteria:
Inclusion criteria:
* Patients of aged 20 years or more.
* Permanent Atrial Fibrillation \[AF\] (defined as duration of AF \> 6 months) for which cardioversion is not considered and with resting ventricular heart rate ≥ 80 bpm at screening.
Exclusion criteria:
* Unstable angina pectoris.
* History of torsades de pointes.
* Prolonged QT corrected interval (≥ 500 ms).
* Third degree atrioventricular block (AVB) on the screening ECG while in AF or, documentation on previous ECGs while in sinus rhythm of PR-interval \> 0.28 sec or high degree AVB (2nd degree or higher) or, significant sinus node disease (documented pause ≥ 3 sec) - without a permanent pacemaker implanted.
* Congestive Heart Failure (CHF) of New York Heart Association classification (NYHA) class IV or recent (within 1 month prior to randomization) unstable NYHA class III.
* Treatment with other class I or III anti-arrhythmic drugs.
* Patients treated with amiodarone during the 4 weeks preceding randomization.
* Clinically relevant haematologic, hepatic, gastro-intestinal, renal, pulmonary, endocrinologic (in particular thyroid) or psychiatric disease.
* Hypokalemia and hypomagnesemia must be corrected before randomization.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01213368
Study Brief:
Protocol Section:
NCT01213368