Cardioversion vs. Catheter Ablation for Persistent Atrial Fibrillation

German Heart Center Munich

Status and phase: Unknown; Phase 4

Conditions: Atrial Fibrillation

Treatments: Procedure: external electric cardioversion; Procedure: catheter ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT00196209

GE IDE No. C00705

Details and patient eligibility

About

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).

Full 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

Enrollment: 130 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

1

Experimental group

Description:

catheter ablation to treat persistent atrial fibrillation

Treatment:

Procedure: catheter ablation

2

Experimental group

Description:

cardioversion and drug prophylaxis to treat persistent atrial fibrillation

Treatment:

Procedure: external electric cardioversion