A Comparative Study Evaluating the Vein of MArshall Ethanol Infusion Ablation Using an Over-the-wire (OTW) Balloon Versus a microcatHeter in Patients With Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 800
- 试验地点
- 5
- 主要终点
- Recovery rate of the mitral isthmus line
研究概览
简要总结
The goal of this study is to compare OTW balloon with microcatheter in the Marshall vein alcohol ablation study. The main questions it aims to answer are: • Is there a difference in the effectiveness and safety of OTW balloon and microcatheter in Marshall vein alcohol ablation? Participants will be asked to:
Undergo treatment with OTW balloon Undergo treatment with microcatheter If there is a comparison group: Researchers will compare the OTW balloon group and the microcatheter group to see different effects.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age range: 18-80 years.
- •Persistent atrial fibrillation or atrial flutter dependent on the mitral isthmus.
- •Inadequate response to antiarrhythmic drug therapy, or intolerance to antiarrhythmic drugs.
- •New York Heart Association functional class ≤ IV,with left ventricular ejection fraction (LVEF) ≥ 35%
排除标准
- •Patients with known allergies to alcohol.
- •Participants with a history of serious cardiovascular events such as myocardial infarction or stroke within the past three months will be excluded from the study
研究组 & 干预措施
OTW group
干预措施: OTW (Device)
Microcatheter group
干预措施: Microcatheter (Device)
结局指标
主要结局
Recovery rate of the mitral isthmus line
时间窗: beyond 3 months after the ablation procedure.
Long-term primary efficacy endpoints
Acute rate of mitral isthmus block
时间窗: During catheter ablation procedures
Efficacy endpoints
Procedural complications
时间窗: During catheter ablation procedures
Safety endpoints
次要结局
- Hospitalization costs(Periprocedural period)
- Procedural characteristics(Periprocedural period)
研究者
Xu Liu
Chief of the Arrhythmia Center
Shanghai Chest Hospital