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

Atrial Fibrillation Clinical Trial

— AMIO-CAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00826826
• Other study ID #: H-A-2008-085
• Secondary ID: H-A-2008-0852612
• Status: Completed
• Phase: N/A
• First received: January 20, 2009
• Last updated: March 4, 2014
• Start date: January 2009
• Est. completion date: January 2014

Study information

• Verified date: March 2014
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Catheter ablation
(Pulmonary vein isolation)

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

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen
Denmark	Gentofte University Hospital	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Quality of Life		6 months	No
Secondary	Adverse outcome/intolerance of antiarrhythmic agent requiring cessation of drug		6 months	Yes
Secondary	Structural and electrical changes (evaluated by echocardiography and digital ECG).		6 months	No
Secondary	Atrial fibrillation burden evaluated by Holter monitoring		6 months	No
Secondary	Asymptomatic atrial fibrillation, atrial flutter or atrial tachycardia documented with Holter.		6 months	No
Secondary	Within blanking period of 3 months: Number AF-related hospitalisations, need for cardioversion or need for additional antiarrythmic drugs.		3 months	No
Secondary	Symptom burden.		6 months	No