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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00826826
Acronym
AMIO-CAT
Enrollment
212
Registered
2009-01-22
Start date
2009-01-31
Completion date
2014-01-31
Last updated
2014-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation, Amiodarone, Arrhythmias, Cardiac, Catheter ablation

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.

Interventions

PROCEDURECatheter ablation

(Pulmonary vein isolation)

DRUGAmiodarone

From the day of the catheter ablation procedure and 8 weeks forward.

DRUGPlacebo

From the day of the catheter ablation procedure and 8 weeks forward.

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Freedom from atrial fibrillation, atrial flutter or atrial tachycardia.6 months from ablation procedurePatients who (based upon clinical decision) are re-ablated within the blanking period counts as having reached an end point.

Secondary

MeasureTime frame
Adverse outcome/intolerance of antiarrhythmic agent requiring cessation of drug6 months
Structural and electrical changes (evaluated by echocardiography and digital ECG).6 months
Atrial fibrillation burden evaluated by Holter monitoring6 months
Quality of Life6 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
Asymptomatic atrial fibrillation, atrial flutter or atrial tachycardia documented with Holter.6 months

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026