Oral Steroids Before Pulmonary Vein Isolation to Improve Outcomes

Phase 4CompletedNCT01206452

Dhanunjaya Lakkireddy, MD, FACC60 enrolled

Overview

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.

The purpose of this study is: 1. To assess the efficacy of oral prednisone in improving the outcomes of pulmonary vein isolation with radiofrequency ablation. 2. 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Atrial Fibrillation

Interventions

PrednisoneDRUG

60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure

PlaceboOTHER

60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure

Ablation ProcedurePROCEDURE

Atrial Fibrillation (AF) ablation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Able to provide written informed consent; 2. Scheduled for radiofrequency ablation procedure for treatment of atrial fibrillation Exclusion Criteria: 1. History of heart failure (right or left or biventricular) or cardiomyopathy. 2. Immunosuppressive disorders and systemic fungal infection 3. Concurrent use of corticosteroids in one week prior recruitment. 4. Allergy or prednisone or its components. 5. Other medical conditions were use of corticosteroids is not recommended or contraindicated. 6. Patients with chronic and permanent atrial fibrillation. 7. Patients with established diagnosis of rheumatological and immunological disorders.

Locations (1)

University Of Kansas Medical Center

Kansas City, Kansas, United States

Outcomes

Primary Outcomes

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.

Time frame: From 6 months up to 12 months post-procedure

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 24 Hours after Ablation Procedure

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.