Efficacy of Different Ablation Strategies in Achieving Long-Term Arrhythmia Control in Patients With Persistent or Permanent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Long-term (greater than 6 months) arrhythmia control in patients with persistent or permanent AF
研究概览
简要总结
This study involves treatment for atrial fibrillation (AF)-the most common heart condition in the US-where the upper chambers of the heart beat very fast and in a disorganized manner. This can be felt as palpitations, tiredness, shortness of breath and passing out, plus can lead to stroke, damage to the heart muscle and a shorter life span. Study participants will receive a common treatment for atrial fibrillation called radiofrequency ablation (RFA), where small lesions or "burns" are made inside the heart to cut off the abnormal impulses that cause AF. The purpose of this study is to compare the effectiveness of three different common ablation strategies in patients with persistent or permanent AF. Subjects will be randomized (like drawing straws) to be treated with one of the three strategies to see if there is a difference in how well atrial fibrillation is controlled after treatment.
详细描述
In most cases, AF originates where the pulmonary veins (PV) enter the left upper chamber of the heart, known as the left atrium (LA). Common to the procedure in each arm of the study is pulmonary vein isolation (PVI) or ablation of tissue around the pulmonary vein entrances. After PVI, the procedure continues with ablation in other areas of the LA where similar abnormal impulses are found. The three strategies for continuing with ablation after PVI are described in the "Arms" section below.
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
- None
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
- •All patients of age ≥ 30 years, undergoing their first ablation procedure that meet ACC / AHA defined criteria for persistent or permanent AF will be eligible to participate in the study. This includes patients with a history of AF episodes lasting at least 7 days or requiring at least 2 cardioversions.
排除标准
- •Patients with paroxysmal AF (self-terminating episodes lasting < 7 day)
- •Patients who have had a previous AF ablation procedure
- •Failure to obtain informed consent
- •Less than 30 years old
研究组 & 干预措施
Group 1
Pulmonary vein isolation (PVI) combined with ablation of documented non-PV triggers of atrial fibrillation --- (sites away from the pulmonary veins where consistent abnormal impulses that can trigger AF are identified during the procedure)
干预措施: Radiofrequency ablation (Procedure)
Group 2
PVI combined with ablation at documented sites of non-PV triggers, PLUS ablation at sites where non-PV triggers are commonly found
干预措施: Radiofrequency ablation (Procedure)
Group 3
PVI combined with ablation at documented sites of non-PV triggers and ablation at sites in the left atrium that demonstrate disorganized electrical impulses called complex fractionated electrograms (CFE).
干预措施: Radiofrequency ablation (Procedure)
结局指标
主要结局
Long-term (greater than 6 months) arrhythmia control in patients with persistent or permanent AF
时间窗: 6 - 12 months
次要结局
未报告次要终点