Cardioversion vs. Catheter Ablation for Persistent Atrial Fibrillation

Study Overview
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Brief Summary
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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
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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

Official Title
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Randomized Study Comparing Cardioversion vs. Catheter Ablation in Patients With Persistent Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: catheter ablation
* Procedure: external electric cardioversion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>catheter ablation to treat persistent atrial fibrillation | Procedure: catheter ablation<br>* catheter ablation to treat persistent atrial fibrillation<br>|
| Experimental: 2<br>cardioversion and drug prophylaxis to treat persistent atrial fibrillation | Procedure: external electric cardioversion<br>* external cardioversion and drug prophylaxis to treat persistent atrial fibrillation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success-rate immediately after intervention |  | success-rate immediately after intervention | 
| 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 | 
| significant improvement in exercise capacity (measured by spiroergometry) |  | 6 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, catheter ablation