Targeted pharmacological reversal of electrical remodeling after cardioversio
- Conditions
- Atrial Fibrillation (AF)Circulatory System
- Registration Number
- ISRCTN62728743
- Lead Sponsor
- German Atrial Fibrillation competence NETwork (AFNET) (Kompetenznetz Vorhofflimmern) (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 635
1. Documented persistent atrial fibrillation
2. Age of 18 years
3. Documented oral anticoagulation (international normalized ratio [INR] =2) for at least three weeks prior to inclusion, or exclusion of left atrial thrombi by trans-esophageal echocardiography
4. Written informed consent of the patient
Exclusion criteria are based on the approval information of flecainide and include, among others, patients with known coronary artery disease or typical angina pectoris, patients with depressed left ventricular ejection fraction (<40%), patients with severely depressed renal or hepatic function, patients with overt thyroid disease, and patients with known Brugada syndrome, sinus node dysfunction or higher degree AV nodal block.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to first recurrence of persistent AF
- Secondary Outcome Measures
Name Time Method 1. Time to first occurrence of a documented relapse of atrial fibrillation<br>2. Number of patients with persistent AF after 6 months<br>3. Number and total duration of documented AF episodes<br>4. Time to termination of trial medication<br>5. Number of hospitalizations due to atrial fibrillation<br>6. Number of visits without hospitalization<br>7. Number of serious adverse events of special interest<br>8. Evolution of left ventricular function<br>9. Quality of life