Corticosteroid Pulse After Ablation (SAAB)
Radiofrequency ablation is an effective treatment for atrial fibrillation. However, about 20% of the time the atrial fibrillation recurs. Steroids given after the ablation may decrease inflammation caused by the ablation and thus improve healing and decrease the chance of recurrence of atrial fibrillation.
In this study patients will be randomized to receive intravenous steroids or not immediately following the ablation.
|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:||SAAB: Randomized, Double Blind STudy of Corticosteroid Pulse After Ablation|
- Composite of severe symptomatic atrial arrythmias, clinically significant atrial arrhythmias lasting >24 hours requiring initiation or change in drug therapy, hospitalization for arrythmias or cardioversion during the initial 6 weeks post ablation [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
- Perception of cardiac pain assessed by a numerical pain scale [ Time Frame: one day and one week ] [ Designated as safety issue: No ]
- Occurrence of shortness of breath or edema requiring administration of a diuretic [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
- Need for repeat ablation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||December 2008|
|Estimated Study Completion Date:||December 2013|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
100mg, given once within 2 hours of the end of the ablation procedure
|Placebo Comparator: Placebo||
Normal saline (1.6 cc)
Atrial fibrillation, a common arrhythmia, is the source of considerable morbidity. Prevalence of atrial fibrillation in adults is 0.5%, increasing to 10% in those patients over the age of seventy five. Numbers are expected to increase nearly 2.5 fold over the next 50 years. Radiofrequency (RF) ablation to cure atrial fibrillation has become an established and effective therapy in the many atrial fibrillation patients. However, approximately 20% return with recurrent atrial fibrillation after ablation.
RF ablation directly targets the substrate for atrial fibrillation, cauterizing cardiac tissue through the application of radiofrequency energy , causing a myocardial lesion which effectively blocks the errant pathway. This process of RF ablation induces an inflammatory effect. As the lesion heals it often enlarges. This may contribute to recurrence of atrial fibrillation after ablation, as well as increased pain. There is some early evidence that a single dose of corticosteroids after ablation may improve the healing process, thus decreasing pain and incidence of recurrent atrial fibrillation.
The aim of the study is to determine the usefulness of a one time dose of solumedrol following radiofrequency ablation for atrial fibrillation..
|United States, Minnesota|
|Abbott Northwestern Hospital|
|Minneapolis, Minnesota, United States, 55407|
|Principal Investigator:||Daniel P Melby, MD||Minneapolis Heart Institute|