Pulsed Field Ablation vs. Cryoballoon Ablation in Patients With Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Freedom from atrial fibrillation recurrence at 12 months
研究概览
简要总结
This clinical study is being conducted to compare two different treatment methods for persistent atrial fibrillation (AF), a common heart rhythm disorder. Atrial fibrillation occurs when the upper chambers of the heart (the atria) beat rapidly and irregularly. This can lead to symptoms like palpitations, shortness of breath, or fatigue, and it increases the risk of stroke or heart failure.
Persistent atrial fibrillation means that the irregular heart rhythm continues and does not stop on its own. Treatment often includes a procedure called catheter ablation, where special instruments are used to create small scars in the heart to block the abnormal electrical signals causing the arrhythmia.
Currently, two main types of catheter ablation are used in Japan:
Cryoballoon Ablation: A technique that uses extreme cold to create scars and isolate the pulmonary veins, which are often the source of the irregular signals.
Pulsed Field Ablation (PFA): A newer technique that uses very short bursts of electrical energy to target the heart tissue, with the aim of reducing damage to surrounding structures.
While pulsed field ablation has been introduced in Japan recently and seems to be safe, there is limited data about how well it works compared to cryoballoon ablation, especially in patients with persistent atrial fibrillation. This study aims to find out whether pulsed field ablation is as effective and safe as cryoballoon ablation for treating persistent AF.
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 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 85 years
- •Diagnosed with PeAF (lasting less than one year or requiring cardioversion)
- •Eligible for catheter ablation according to current Japanese guidelines
- •Provided written informed consent
排除标准
- •Paroxysmal or long-standing persistent AF (duration >1 year)
结局指标
主要结局
Freedom from atrial fibrillation recurrence at 12 months
时间窗: 12 months post-procedure
Proportion of patients without documented atrial fibrillation lasting 30 seconds or longer after a 3-month blanking period following the ablation procedure, assessed by ECG or Holter monitoring.
次要结局
未报告次要终点
研究者
Hidehira Fukaya
Junior Associate Professor
Kitasato University
