The Effect of Short Term Amiodarone Treatment After Catheter Ablation for Atrial Fibrillation - Full Text View

Sponsor:	Rigshospitalet, Denmark
Information provided by (Responsible Party):	Stine Darkner, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00826826

Purpose

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	Intervention
Atrial Fibrillation	Procedure: Catheter ablation Drug: Amiodarone Drug: Placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Arrhythmia Atrial Fibrillation

Drug Information available for: Amiodarone hydrochloride Amidox Amiodarone

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:

Freedom from atrial fibrillation, atrial flutter or atrial tachycardia. [ Time Frame: at 6 months from ablation procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	250
Study Start Date:	January 2009
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Antiarrythmic drug	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.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Drug refractory, symptomatic paroxysmal or persistent 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826826

Contacts

Contact: Jesper H Svendsen, MD	(+45) 35452817
Contact: Stine Darkner, MD	(+45) 35450491

Locations

Denmark
Rigshospitalet	Recruiting
Copenhagen, Denmark, 2100
Contact: Jesper H Svendsen, MD (+45) 35452817
Contact: Stine Darkner, MD (+45) 35450491 stine.darkner@rh.regionh.dk
Sub-Investigator: Steen Pehrson, MD
Sub-Investigator: Xu Chen, MD
Principal Investigator: Stine Darkner, MD
Gentofte University Hospital	Not yet recruiting
Hellerup, Denmark, 2900
Contact: Jim Hansen, MD, DMsc JIHA@geh.regionh.dk
Contact: Stine Darkner, MD stine.darkner@rh.regionh.dk
Principal Investigator: Jim Hansen, MD, DMSc
Sub-Investigator: Arne Johannessen, MD, DMSc
Sub-Investigator: Stine Darkner, MD

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

Principal Investigator:	Stine Darkner, MD	Rigshospitalet, Denmark
Study Director:	Jesper H Svendsen, MD	Rigshospitalet, Denmark

More Information

No publications provided

Responsible Party:	Stine Darkner, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00826826 History of Changes
Other Study ID Numbers:	H-A-2008-085, H-A-2008-085, 2612-3819, 2008-004500-32
Study First Received:	January 20, 2009
Last Updated:	August 25, 2011
Health Authority:	Denmark: Danish Medicines Agency; Denmark: The Regional Committee on Biomedical Research Ethics; Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:

Atrial fibrillation
Amiodarone
Arrhythmias, Cardiac
Catheter ablation

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amiodarone
Anti-Arrhythmia Agents

Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on February 09, 2012