The Effect of Short Term Amiodarone Treatment After Catheter Ablation for Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
The Effect of Short Term Amiodarone Treatment on Success Rate and Quality of Life After Catheter Ablation for Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: Catheter ablation
* Drug: Amiodarone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with symptomatic paroxysmal or persistent atrial fibrillation undergoing catheter ablation for atrial fibrillation. (persistent episodes may last no more than 12 months) Exclusion Criteria: Contraindication or intolerance to amiodarone. Prolonged amiodarone treatment within 3 months before the planned ablation procedure. Previous participation in this study. Other cardiac arrythmias (patients with co-existing atrial flutter can be included). Antiarrhythmic treatment for indication other than atrial fibrillation (or atrial flutter). Heart failure (NYHA class III or IV or left ventricular ejection fraction < 35%). Significant heart valve disease. Significant lung disease, thyroid dysfunction or liver disease. Inability or unwillingness to be treated with anticoagulation before and during the study. Females with birth giving potential Failure to give informed concent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Amiodarone<br> | Procedure: Catheter ablation<br>* (Pulmonary vein isolation)<br>Drug: Amiodarone<br>* From the day of the catheter ablation procedure and 8 weeks forward.<br>|
| Placebo Comparator: Placebo<br> | Procedure: Catheter ablation<br>* (Pulmonary vein isolation)<br>Drug: Placebo<br>* From the day of the catheter ablation procedure and 8 weeks forward.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months from ablation procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life |  | 6 months | 
| Adverse outcome/intolerance of antiarrhythmic agent requiring cessation of drug |  | 6 months | 
| Structural and electrical changes (evaluated by echocardiography and digital ECG). |  | 6 months | 
| Atrial fibrillation burden evaluated by Holter monitoring |  | 6 months | 
| Asymptomatic atrial fibrillation, atrial flutter or atrial tachycardia documented with Holter. |  | 6 months | 
| Within blanking period of 3 months: Number AF-related hospitalisations, need for cardioversion or need for additional antiarrythmic drugs. |  | 3 months | 
| Symptom burden. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial fibrillation, Amiodarone, Arrhythmias, Cardiac, Catheter ablation