Corticosteroid Pulse After Ablation (SAAB)

Minneapolis Heart Institute Foundation

Status and phase: Completed; Phase 4

Conditions: Atrial Fibrillation

Treatments: Drug: Solumedrol; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00807586

ep002

Details and patient eligibility

About

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.

Full 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..

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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119 participants in 2 patient groups, including a placebo group

Steroid

Experimental group

Treatment:

Drug: Solumedrol

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo