Clinical trial NCT00196209: Cardioversion vs. Catheter Ablation for Persistent Atrial Fibrillation
Official title: Randomized Study Comparing Cardioversion vs. Catheter Ablation in Patients With Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
catheter ablation
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 130
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: 6 months
Secondary outcomes:
measure: success-rate immediately after intervention
timeFrame: success-rate immediately after intervention
measure: 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)
timeFrame: 2-3 months
measure: burden of atrial fibrillation in a 7-day-holter after 6 months
timeFrame: 6 months
measure: significant improvement in exercise capacity (measured by spiroergometry)
timeFrame: 6 months
measure: decrease in NT-pro-BNP levels in the blood after 6 months compared to the level before initial intervention
timeFrame: 6 months
measure: improvement of quality-of-life (combined questionnaire including the SF-36 form) before initial intervention and at the 6-months follow-up
timeFrame: 6 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen
Study officials:
affiliation: Deutsches Herzzentrum Muenchen
name: Isabel Deisenhofer, MD
role: STUDY_CHAIR
affiliation: Deutsches Herzzentrum Muenchen
name: Heidi L Estner, MD
role: PRINCIPAL_INVESTIGATOR
References: