NCT05462145进行中（未招募）不适用
A Prospective, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Kardium Inc.
- 入组人数
- 549
- 试验地点
- 37
- 主要终点
- Effectiveness endpoint
研究概览
简要总结
This study will evaluate the safety and effectiveness of the Globe® Pulsed Field System for treating patients with symptomatic paroxysmal or persistent atrial fibrillation (AF).
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
研究组 & 干预措施
Globe Pulsed Field System
Experimental
干预措施: Globe Pulsed Field System (Device)
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 (37)
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