Clinical trial NCT00826826: The Effect of Short Term Amiodarone Treatment After Catheter Ablation for Atrial Fibrillation
Official title: The Effect of Short Term Amiodarone Treatment on Success Rate and Quality of Life After Catheter Ablation for Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Amiodarone
Arrhythmias, Cardiac
Catheter ablation
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2009-01-22
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Freedom from atrial fibrillation, atrial flutter or atrial tachycardia.
timeFrame: 6 months from ablation procedure
Secondary outcomes:
measure: Quality of Life
timeFrame: 6 months
measure: Adverse outcome/intolerance of antiarrhythmic agent requiring cessation of drug
timeFrame: 6 months
measure: Structural and electrical changes (evaluated by echocardiography and digital ECG).
timeFrame: 6 months
measure: Atrial fibrillation burden evaluated by Holter monitoring
timeFrame: 6 months
measure: Asymptomatic atrial fibrillation, atrial flutter or atrial tachycardia documented with Holter.
timeFrame: 6 months
measure: Within blanking period of 3 months: Number AF-related hospitalisations, need for cardioversion or need for additional antiarrythmic drugs.
timeFrame: 3 months
measure: Symptom burden.
timeFrame: 6 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Hellerup
country: Denmark
facility: Gentofte University Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Stine Darkner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Jesper H Svendsen, MD, DMSc
role: STUDY_DIRECTOR
References: