Cardioversion vs. Catheter Ablation for Persistent Atrial Fibrillation

Phase 4

• Conditions: Atrial Fibrillation
• Interventions: Procedure: catheter ablation; Procedure: external electric cardioversion

• Registration Number: NCT00196209
• Lead Sponsor: Deutsches Herzzentrum Muenchen

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

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-19
• Study First Posted: 2005-09-20
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-18
• Last Update Posted: 2008-03-19
• Primary Completion: 2009-06
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	catheter ablation	catheter ablation to treat persistent atrial fibrillation
2	external electric cardioversion	cardioversion and drug prophylaxis to treat persistent atrial fibrillation

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Deutsches Herzzentrum Muenchen; 🇩🇪 Munich, Germany