Use of Oral Steroids Before Circumferential Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation to Improve Outcomes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of Participants With Atrial Fibrillation Recurrence From 6 Months up to 12 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide written informed consent;
- •Scheduled for radiofrequency ablation procedure for treatment of atrial fibrillation
排除标准
- •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.
研究组 & 干预措施
Ablation plus prednisone
Participants undergo ablation procedure and receive predinisone at protocol determined times.
干预措施: Prednisone (Drug)
Ablation plus prednisone
Participants undergo ablation procedure and receive predinisone at protocol determined times.
干预措施: Ablation Procedure (Procedure)
Ablation plus placebo
Participants undergo ablation procedure and receive placebo at protocol determined times.
干预措施: Placebo (Other)
Ablation plus placebo
Participants undergo ablation procedure and receive placebo at protocol determined times.
干预措施: Ablation Procedure (Procedure)
结局指标
主要结局
Number of Participants With Atrial Fibrillation Recurrence From 6 Months up to 12 Months
时间窗: From 6 months up to 12 months post-procedure
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.
次要结局
- Number of Participants With Atrial Fibrillation Recurrence From 0 Months up to 3 Months(From 0 months up to 3 months post procedure)
- Number of Participants With Atrial Fibrillation Recurrence From 3 Months up to 6 Months(From 3 months up to 6 months post-procedure)
- Inflammatory Cytokine Response to Ablation Procedure(24 Hours after Ablation Procedure)
研究者
Dhanunjaya Lakkireddy, MD, FACC
Professor of Medicine
University of Kansas Medical Center