NCT06973031招募中不适用
A Prospective Clinical Study to Evaluate the Safety and Effectiveness of Pulmonary Vein Isolation Plus Box Isolation of Fibrotic Areas With the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Kardium Inc.
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Effectiveness endpoint
研究概览
简要总结
The study will evaluate the safety and 12-month effectiveness of the Pulmonary Vein Isolation plus Box Isolation of Fibrotic Areas (BIFA) ablation strategy with the Globe Pulsed Field System (Globe PF System) for the treatment of atrial fibrillation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 否
入选标准
- •A diagnosis of recurrent symptomatic paroxysmal or persistent AF
- •Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III
排除标准
- •Long-standing persistent AF (sustained >12 months)
- •Atrial fibrillation secondary to a reversible cause or of non-cardiac origin
- •History of thromboembolic events within the past six months
- •Myocardial infarction (MI)/percutaneous coronary intervention (PCI) within the last three months
- •Any cardiac surgery within the previous six months
- •Prior left atrial ablation or surgical procedure
- •Presence of an implanted cardiac device
- •Body mass index (BMI) >40 kg/m^2
- •Left ventricular ejection fraction (LVEF) <35%
- •Anterior-posterior left atrial (LA) diameter >55mm
结局指标
主要结局
Effectiveness endpoint
时间窗: 12 months
Number of subjects with freedom from documented atrial fibrillation, atrial flutter, and atrial tachycardia (AF/AFL/AT) 12 months post-procedure.
Safety endpoint
时间窗: 7 days
Rate of subjects presenting with one or more of the specified primary safety events within 7 days of the index ablation procedure.
次要结局
未报告次要终点
研究者
研究点 (2)
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