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Targeted pharmacological reversal of electrical remodeling after cardioversion

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN62728743
Enrollment
635
Registered
2005-08-02
Start date
2005-03-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation (AF) Circulatory System

Interventions

Targeted, short-term pharmacological reversal of electrical remodeling is not inferior to prevent recurrent AF after cardioversion when compared to standard long-term antiarrhythmic medication.

Sponsors

German Atrial Fibrillation competence NETwork (AFNET) (Kompetenznetz Vorhofflimmern) (Germany)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: 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.

Design outcomes

Secondary

MeasureTime frame
1. Time to first occurrence of a documented relapse of atrial fibrillation 2. Number of patients with persistent AF after 6 months 3. Number and total duration of documented AF episodes 4. Time to termination of trial medication 5. Number of hospitalizations due to atrial fibrillation 6. Number of visits without hospitalization 7. Number of serious adverse events of special interest 8. Evolution of left ventricular function 9. Quality of life

Primary

MeasureTime frame
Time to first recurrence of persistent AF

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 23, 2026