NCT00807586

Corticosteroid Pulse After Ablation

SAAB: Randomized, Double Blind STudy of Corticosteroid Pulse After Ablation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Minneapolis Heart Institute Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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..

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Solumedrol	100mg, given once within 2 hours of the end of the ablation procedure
DRUG	Placebo	Normal saline (1.6 cc)

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-12-01
• Completion: 2013-12-01
• First posted: 2008-12-12
• Last updated: 2019-08-20
• Results posted: 2019-08-20

Locations

1 site across 1 country: United States