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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00826826
Recruitment Status : Completed
First Posted : January 22, 2009
Last Update Posted : March 5, 2014
Information provided by (Responsible Party):
Stine Darkner, Rigshospitalet, Denmark

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: Catheter ablation Drug: Amiodarone Drug: Placebo Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Short Term Amiodarone Treatment on Success Rate and Quality of Life After Catheter Ablation for Atrial Fibrillation
Study Start Date : January 2009
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Amiodarone Procedure: Catheter ablation
(Pulmonary vein isolation)

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

Placebo Comparator: Placebo Procedure: Catheter ablation
(Pulmonary vein isolation)

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

Primary Outcome Measures :
  1. Freedom from atrial fibrillation, atrial flutter or atrial tachycardia. [ Time Frame: 6 months from ablation procedure ]
    Patients who (based upon clinical decision) are re-ablated within the blanking period counts as having reached an end point.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00826826

Copenhagen, Denmark, 2100
Gentofte University Hospital
Hellerup, Denmark, 2900
Sponsors and Collaborators
Rigshospitalet, Denmark
Principal Investigator: Stine Darkner, MD Rigshospitalet, Denmark
Study Director: Jesper H Svendsen, MD, DMSc Rigshospitalet, Denmark

Responsible Party: Stine Darkner, MD, Rigshospitalet, Denmark Identifier: NCT00826826     History of Changes
Other Study ID Numbers: H-A-2008-085
First Posted: January 22, 2009    Key Record Dates
Last Update Posted: March 5, 2014
Last Verified: March 2014

Keywords provided by Stine Darkner, Rigshospitalet, Denmark:
Atrial fibrillation
Arrhythmias, Cardiac
Catheter ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors