The objective of this multicenter randomized study is to establish the effectiveness of treatment for paroxysmal atrial fibrillation (AF), in patients not previously treated with anti-arrhythmic drugs, by encircling the pulmonary veins with radiofrequency (RF) ablation, using the NaviStar® ThermoCool® catheter and the CARTO™ EP Navigation System. Effectiveness will be determined by comparing chronic success of ablation therapy versus anti-arrhythmic drug treatment, defined as patients with an absence of atrial tachycardias during 24 months of follow-up as determined by 7-days Holter and transtelephonic monitoring, and by 12-lead electrocardiogram (ECG) recordings.
This study is a prospective, randomized, multicenter clinical study that will enroll in its first phase 40 patients. The study will be performed in 3 European hospitals. Patients will be randomized to either the RF ablation strategy or to the medication arm. Hypothesis: As first line therapy, catheter ablation improves the long-term success, health-economic outcomes and is equally safe compared to the best anti-arrhythmic medication treatment in a selected group of patients with paroxysmal atrial fibrillation. Primary endpoint: * long-term success, defined as patients free from any atrial fibrillation during 24 months after initial study treatment as determined by 7-days Holter and transtelephonic monitoring and by 12-lead ECG recordings. Secondary endpoints: * AF burden: frequency and duration of episodes * health-economic costs over 24 months * serious adverse events * Quality of Life scores, using SF-36 questionnaire
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
long-term success
Time frame: 19 months
AF-burden
Time frame: 19 months
health-economic costs
Time frame: 24 months
serious adverse events
Time frame: 19 months
Quality of Life scores
Time frame: 19 months
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