Oral Steroids Before Pulmonary Vein Isolation to Improve Outcomes

Study Overview
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Brief Summary
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The primary purpose of this study is to assess the efficacy of oral prednisone in improving the outcomes of pulmonary vein isolation with radiofrequency ablation.

Detailed Description
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The purpose of this study is: To assess the efficacy of oral prednisone in improving the outcomes of pulmonary vein isolation with radiofrequency ablation. To measure the inflammatory cytokine (TNF-α, IL-1, IL-6, IL-8) response to radiofrequency ablation for atrial fibrillation with or without prior prednisone treatment.

Official Title
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Use of Oral Steroids Before Circumferential Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation to Improve Outcomes

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Prednisone
* Other: Placebo
* Procedure: Ablation Procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to provide written informed consent; Scheduled for radiofrequency ablation procedure for treatment of atrial fibrillation Exclusion Criteria: History of heart failure (right or left or biventricular) or cardiomyopathy. Immunosuppressive disorders and systemic fungal infection Concurrent use of corticosteroids in one week prior recruitment. Allergy or prednisone or its components. Other medical conditions were use of corticosteroids is not recommended or contraindicated. Patients with chronic and permanent atrial fibrillation. Patients with established diagnosis of rheumatological and immunological disorders.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ablation plus prednisone<br>Participants undergo ablation procedure and receive predinisone at protocol determined times. | Drug: Prednisone<br>* 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure<br>Procedure: Ablation Procedure<br>* Atrial Fibrillation (AF) ablation<br>|
| Placebo Comparator: Ablation plus placebo<br>Participants undergo ablation procedure and receive placebo at protocol determined times. | Other: Placebo<br>* 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure<br>Procedure: Ablation Procedure<br>* Atrial Fibrillation (AF) ablation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Atrial Fibrillation Recurrence From 6 Months up to 12 Months | Number of AF recurrences between the two study groups as assessed by 1-month event monitor placed at 6 and 12 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence. | From 6 months up to 12 months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Atrial Fibrillation Recurrence From 0 Months up to 3 Months | Number of AF recurrences between the two study groups as assessed by inpatient telemetry in the immediate post-procedure period until discharge and 1-month event monitor placed at 3 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence. | From 0 months up to 3 months post procedure | 
| Number of Participants With Atrial Fibrillation Recurrence From 3 Months up to 6 Months | Number of AF recurrences between the two study groups as assessed by 1-month event monitor placed at 3 and 6 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence. | From 3 months up to 6 months post-procedure | 
| Inflammatory Cytokine Response to Ablation Procedure | Measure inflammatory marker levels, including IL-1, IL-6, IL-8, and TNF-α, immediately post-ablation in keeping with prior studies on the anti-inflammatory effects of steroids following cardiac surgery. | Immediately Post-Ablation Procedure | 
| Inflammatory Cytokine Response to Ablation Procedure | Measure inflammatory marker levels, including IL-1, IL-6, IL-8, and TNF-α, 24 hours post-ablation to assess interval response to steroid administration. | 24 Hours after Ablation Procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation; Ablation