The purpose of the study is to demonstrate that in patients of 70 years or older with symptomatic paroxysmal atrial fibrillation (AF) pulmonary vein isolation (PVI) using RF ablation therapy is superior to medical treatment with amiodarone to prevent recurrence of AF.
Atrial fibrillation (AF) is the most common arrhythmia. The prevalence of AF is highly age dependent as 70% of AF patients is between 65 and 85 years old. With increasing life expectancy, AF prevalence will increase 2,5 times during the next 50 years and constitute an even more important health concern. In younger patients Pulmonary vein ablation is an accepted procedure with superior efficacy compared to medical treatment. In this study the safety and efficacy of PVI in patients over 70 years old will be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
59
Pulmonary Vein Ablation using RF.
Amiodarone tablets
Elkerliek Hospital
Helmond, North Brabant, Netherlands
Maxima Medical Center
Veldhoven, North Brabant, Netherlands
Haga Hospital
The Hague, South Holland, Netherlands
Onze Lieve Vrouwen Gasthuis
Amsterdam, Netherlands
Recurrence of episodes of AF, atypical atrial flutter or left sided atrial tachycardia
Time frame: Until 1 year after post treatment blanking period
Composite end point of hospitalization, stroke, major bleeding and death
Time frame: Until last patient has been followed for 15 months after inclusion
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Catharina Ziekenhuis
Eindhoven, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands