Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Rigshospitalet, Denmark |
---|---|
Information provided by: | Rigshospitalet, Denmark |
ClinicalTrials.gov Identifier: | NCT00826826 |
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: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | The Effect of Short Term Amiodarone Treatment on Success Rate and Quality af Life After Catheter Ablation for Atrial Fibrillation |
Estimated Enrollment: | 250 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | February 2012 |
Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Antiarrythmic drug: Active Comparator |
Procedure: Catheter ablation
(Pulmonary vein isolation)
Drug: Amiodarone
From the day of the catheter ablation procedure and 8 weeks forward.
|
Placebo: Placebo Comparator |
Procedure: Catheter ablation
(Pulmonary vein isolation)
Drug: Placebo
From the day of the catheter ablation procedure and 8 weeks forward.
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jesper H Svendsen, MD | (+45) 35452817 | |
Contact: Stine Darkner, MD | (+45) 35450491 |
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 | Rigshospitalet, Denmark |
Study Director: | Jesper H Svendsen, MD | Rigshospitalet, Denmark |
Responsible Party: | Rigshospitalet, Denmark ( Jesper H Svendsen, MD ) |
Study ID Numbers: | H-A-2008-085, H-A-2008-085, 2612-3819, 2008-004500-32 |
Study First Received: | January 20, 2009 |
Last Updated: | January 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00826826 History of Changes |
Health Authority: | Denmark: Danish Medicines Agency; Denmark: The Regional Committee on Biomedical Research Ethics; Denmark: Danish Dataprotection Agency |
Atrial fibrillation Amiodarone Arrhythmias, Cardiac Catheter ablation |
Vasodilator Agents Heart Diseases Cardiovascular Agents Anti-Arrhythmia Agents |
Atrial Fibrillation Amiodarone Arrhythmias, Cardiac |
Vasodilator Agents Heart Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Cardiovascular Agents Amiodarone Pharmacologic Actions |
Pathologic Processes Therapeutic Uses Cardiovascular Diseases Atrial Fibrillation Anti-Arrhythmia Agents Arrhythmias, Cardiac |