Atrial Fibrillation
Conditions
Keywords
atrial fibrillation, catheter ablation
Brief summary
The aim of this randomized study is to evaluate the efficacy of two different approaches for conversion of persistent atrial fibrillation, the non-invasive one (external electrical cardioversion) and the invasive one (catheter ablation).
Detailed description
This randomized study compares two treatment strategies in patients with persistent atrial fibrillation: Cardioversion vs. catheter ablation. Cardioversion is a low risk standard treatment option for patients with persistent atrial fibrillation. However, mid- and long term efficacy (regarding the maintenance of sinus rhythm) is low. Catheter ablation is an invasive treatment which has been reported to result in up to 60-70% of patients in stable sinus rhythm. However, it is a potentially dangerous invasive procedure with potentially fatal complications. Comparison: External cardioversion vs. catheter ablation
Interventions
PROCEDUREcatheter ablation
catheter ablation to treat persistent atrial fibrillation
PROCEDUREexternal electric cardioversion
external cardioversion and drug prophylaxis to treat persistent atrial fibrillation
Sponsors
Deutsches Herzzentrum Muenchen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age \>20 years and \<75 years * documented persistent atrial fibrillation for at least 3 months (documented in at least 2 ECGs or holter-ECGs during the previous 3 months before inclusion and persistent atrial fibrillation in a 7-d-holter) * documented sufficient anticoagulation for at least 4 weeks before inclusion
Exclusion criteria
* Paroxysmal atrial fibrillation * NYHA IV (if recompensation is not possible) * Contraindication for warfarin * Disturbance of blood coagulation * Myocardial infarction, PTCA/stenting, bypass-operation, stroke, intracranial bleeding less than 3 months before * Reversible causes of atrial fibrillation (i.e. hyperthyroidism) * Pregnancy * LA-diameter \> 55mm * LV-function \< 30% EF * Aortic or mitral stenosis or regurgitation III°-IV° * Prosthetic valves
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival after 6 months (i.e. freedom of atrial tachyarrhythmias - as evaluated in a 7-d-holter, stroke, pulmonary vein stenosis - as evaluated in a CT-/MRT-scan 6 months after the initial procedure - and death). | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| need for re-intervention between 2 and 3 months after initial procedure if not stable sinus rhythm at the two-months follow-up (further ablation/cardioversion) | 2-3 months |
| burden of atrial fibrillation in a 7-day-holter after 6 months | 6 months |
| success-rate immediately after intervention | success-rate immediately after intervention |
| decrease in NT-pro-BNP levels in the blood after 6 months compared to the level before initial intervention | 6 months |
| improvement of quality-of-life (combined questionnaire including the SF-36 form) before initial intervention and at the 6-months follow-up | 6 months |
| significant improvement in exercise capacity (measured by spiroergometry) | 6 months |
Countries
Germany
Contacts
Primary ContactHeidi L Estner, MD
Outcome results
None listed