Paroxysmal atrial fibrillation
Conditions
Interventions
Flecainide therapy 100-200mg daily
Pilsicainide therapy 75-225mg daily
Sponsors
Steering committee in the multicenter study of rhythm-control drugs in patients with paroxysmal atrial fibrillation (Department of Cardiology, Tokyo Women's Medical University)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1:History of symptomatic paroxysmal atrial fibrillation of a frequency of two or more attacks per month, and paroxysmal atrial fibrillation was previously indentified by electrocardiography when patient complained symptom. 2:Presence of sinus rhythm before the start of the study. 3. Patients who gave written informed consent to participate.
Exclusion criteria
Exclusion criteria: 1. Patients with obvious structural heart disease. 2. Potentially dangerous symptoms associated with paroxysmal atrial fibrillation, such as syncope and transient ischemic attacks. 3. History of cerebral vascular accident associated with occurrence of paroxysmal atrial fibrillation. 4. Excessive bradycardia (<40 bpm) or sick sinus syndrome. 5. PR interval 0.28 or more second, second or third degree atrioventricular block, bundle branch block, severe intraventricular conduction delay. 6. Implantation of pacemaker or implantable cardioverter-defibrillator. 7. Paroxysmal atrial fibrillation caused by reversible, noncardiac disease such as hyperthyroidism. 8. Requirement of ongoing therapy with other antiarrhythmic drug. 9. Significant serious noncardiac disease such as hepatic, renal, hematological and lung diseases. 10. Pregnancy or possibility of pregnancy, and breast feeding. 11. Judgement by attending physician that patient participation would be inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of days when atrial fibrillation is recorded on ambulatory electrocardiogram for a period of 5-12 weeks (treatment phase) | — |
Secondary
| Measure | Time frame |
|---|---|
| Time(days) to first documented atrial fiberillation after 4 weeks of dose finding period. Quality of life (SF-36 score, AFQLQ score) | — |
Countries
Japan
Contacts
Public ContactTsuyoshi Shiga
Tokyo Women's Medical University Cardiology
Outcome results
None listed