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The Effect of Short Term Amiodarone Treatment After Catheter Ablation for Atrial Fibrillation (AMIO-CAT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stine Darkner, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00826826
First received: January 20, 2009
Last updated: March 4, 2014
Last verified: March 2014

January 20, 2009
March 4, 2014
January 2009
January 2014   (final data collection date for primary outcome measure)
Freedom from atrial fibrillation, atrial flutter or atrial tachycardia. [ Time Frame: 6 months from ablation procedure ] [ Designated as safety issue: No ]
Patients who (based upon clinical decision) are re-ablated within the blanking period counts as having reached an end point.
Freedom from atrial fibrillation, atrial flutter or atrial tachycardia. [ Time Frame: at 6 months from ablation procedure ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00826826 on ClinicalTrials.gov Archive Site
  • Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Adverse outcome/intolerance of antiarrhythmic agent requiring cessation of drug [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Structural and electrical changes (evaluated by echocardiography and digital ECG). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Atrial fibrillation burden evaluated by Holter monitoring [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Asymptomatic atrial fibrillation, atrial flutter or atrial tachycardia documented with Holter. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Within blanking period of 3 months: Number AF-related hospitalisations, need for cardioversion or need for additional antiarrythmic drugs. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Symptom burden. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Atrial Fibrillation
  • Procedure: Catheter ablation
    (Pulmonary vein isolation)
  • Drug: Amiodarone
    From the day of the catheter ablation procedure and 8 weeks forward.
  • Drug: Placebo
    From the day of the catheter ablation procedure and 8 weeks forward.
  • Active Comparator: Amiodarone
    Interventions:
    • Procedure: Catheter ablation
    • Drug: Amiodarone
  • Placebo Comparator: Placebo
    Interventions:
    • Procedure: Catheter ablation
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
212
January 2014
January 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00826826
H-A-2008-085, H-A-2008-085, 2612-3819, 2008-004500-32
Yes
Stine Darkner, Rigshospitalet, Denmark
Rigshospitalet, Denmark
Not Provided
Principal Investigator: Stine Darkner, MD Rigshospitalet, Denmark
Study Director: Jesper H Svendsen, MD, DMSc Rigshospitalet, Denmark
Rigshospitalet, Denmark
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP