Corticosteroid Pulse After Ablation

Study Overview
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Brief Summary
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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
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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..

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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Solumedrol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Steroid<br> | Drug: Solumedrol<br>* 100mg, given once within 2 hours of the end of the ablation procedure<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Normal saline (1.6 cc)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Clinically Significant Atrial Arrhythmias at 6 Weeks | Clinically significant atrial arrhythmias include ER, urgent care, or hospitalization for atrial fibrillation, cardioversion for atrial fibrillation, or atrial fibrillation requiring an increase in anti-arrhythmia medication | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Pain Assessment | Perception of cardiac pain assessed by a numerical pain scale (0= no pain; 10=worst pain imaginable) | one day and one week | 
| Symptoms Post Ablation Requiring Diuretic | Occurrence of shortness of breath or edema requiring administration of a diuretic | 6 weeks | 
| Repeat Intervention | Need for repeat ablation | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Corticosteroid, Radiofrequency catheter ablation for atrial fibrillation