Atrial Fibrillation Clinical Trial
Official title:
The Effect of Short Term Amiodarone Treatment on Success Rate and Quality of Life After Catheter Ablation for Atrial Fibrillation
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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