The purpose of this study is to examine the overall effectiveness of short-time anti-arrhythmic drug treatment with amiodarone (to control heart rhythm) to prevent short-and long-term atrial fibrillation following an ablation procedure for atrial fibrillation.
Atrial fibrillation (AF) is the most common cardiac arrhythmia, and it is associated with increased mortality and morbidity due to increased risk of stroke, poor quality of life and risk of developing heart failure. Today, catheter ablation has become a standard procedure in the treatment of symptomatic atrial fibrillation, but so far there is no official recommendations regarding the use of antiarrythmic drugs after the procedure. Nevertheless, it is common standard practice to prescribe antiarrhythmic drugs for the first 2-3 months after the intervention to prevent early recurrences. To our knowledge, the effect of antiarrythmic drugs following ablation for atrial fibrillation has only been evaluated in a few recent studies. None of these have evaluated the long term effect of short term antiarrythmic drug treatment. In addition, none of the trials have been conducted placebo-controlled. In this study patients with paroxysmal or persistent atrial fibrillation will be considered for randomisation. Following the ablation procedure, patients will be randomized to receive either amiodarone or placebo for a period of 8 weeks. Clinical visits including a physical exam, 12 lead ECG recording and blood samples, will be scheduled during the follow-up time. Furthermore patients will be evaluated with Quality of Life questionaires and Holter monitoring. The primary endpoint of the study is freedom from atrial fibrillation, atrial flutter or atrial tachycardia at 6 months follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
212
(Pulmonary vein isolation)
From the day of the catheter ablation procedure and 8 weeks forward.
From the day of the catheter ablation procedure and 8 weeks forward.
Rigshospitalet
Copenhagen, Denmark
Gentofte University Hospital
Hellerup, Denmark
Freedom from atrial fibrillation, atrial flutter or atrial tachycardia.
Patients who (based upon clinical decision) are re-ablated within the blanking period counts as having reached an end point.
Time frame: 6 months from ablation procedure
Quality of Life
Time frame: 6 months
Adverse outcome/intolerance of antiarrhythmic agent requiring cessation of drug
Time frame: 6 months
Structural and electrical changes (evaluated by echocardiography and digital ECG).
Time frame: 6 months
Atrial fibrillation burden evaluated by Holter monitoring
Time frame: 6 months
Asymptomatic atrial fibrillation, atrial flutter or atrial tachycardia documented with Holter.
Time frame: 6 months
Within blanking period of 3 months: Number AF-related hospitalisations, need for cardioversion or need for additional antiarrythmic drugs.
Time frame: 3 months
Symptom burden.
Time frame: 6 months
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