This trial is active, not recruiting.

Condition atrial fibrillation
Treatments solumedrol, placebo
Phase phase 4
Sponsor Minneapolis Heart Institute Foundation
Collaborator St. Jude Medical
Start date December 2008
End date December 2009
Trial size 120 participants
Trial identifier NCT00807586, ep002


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
100mg, given once within 2 hours of the end of the ablation procedure
(Placebo Comparator)
Normal saline (1.6 cc)

Primary Outcomes

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

Secondary Outcomes

Perception of cardiac pain assessed by a numerical pain scale
time frame: one day and one week
Occurrence of shortness of breath or edema requiring administration of a diuretic
time frame: 6 weeks
Need for repeat ablation
time frame: 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Age ≥ 18 - Drug refractory, symptomatic paroxysmal atrial fibrillation Exclusion Criteria: - Contraindication to solumedrol - Persistent or permanent Atrial Fibrillation - Previous history of radiofrequency ablation for atrial fibrillation

Additional Information

Official title SAAB: Randomized, Double Blind STudy of Corticosteroid Pulse After Ablation
Principal investigator Daniel P Melby, MD
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..
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by Minneapolis Heart Institute Foundation.