Cardioversion vs. Catheter Ablation for Persistent Atrial Fibrillation

Phase 4UnknownNCT00196209

Deutsches Herzzentrum Muenchen130 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

130

Conditions

Atrial Fibrillation

Interventions

catheter ablationPROCEDURE

catheter ablation to treat persistent atrial fibrillation

external electric cardioversionPROCEDURE

external cardioversion and drug prophylaxis to treat persistent atrial fibrillation

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Deutsches Herzzentrum Muenchen

Munich, Germany

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: 6 months

Secondary Outcomes

success-rate immediately after intervention

Time frame: 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)

Time frame: 2-3 months

burden of atrial fibrillation in a 7-day-holter after 6 months

Time frame: 6 months

significant improvement in exercise capacity (measured by spiroergometry)

Time frame: 6 months

decrease in NT-pro-BNP levels in the blood after 6 months compared to the level before initial intervention

Time frame: 6 months

improvement of quality-of-life (combined questionnaire including the SF-36 form) before initial intervention and at the 6-months follow-up

Time frame: 6 months

Central Contacts

Heidi L Estner, MD

CONTACT

0049 89 1218 2020 estner@dhm.mhn.de

Data from ClinicalTrials.gov

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