Post-Approval Study of the HeartLight Endoscopic Ablation System for the Treatment of Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- CardioFocus
- 入组人数
- 250
- 试验地点
- 7
- 主要终点
- The proportion of participants free from symptomatic atrial fibrillation (AF) or symptomatic atypical atrial flutter/atrial tachycardia (AFL/AT) lasting longer than 30 seconds post the 90 day blanking period
研究概览
简要总结
This is a post-approval study to evaluate the clinical outcomes in a cohort of participants treated during commercial use of the HeartLight System to confirm results of the previously conducted pivotal clinical study.
详细描述
This is a prospective, open-label, multi-center, single arm study designed to assess continued safety and effectiveness of the HeartLight System during commercial use in participants being treated for drug refractory, symptomatic, paroxysmal 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •planned for catheter ablation due to symptomatic paroxysmal atrial fibrillation
- •failure of at least one anti-arrhythmic drug
排除标准
- •overall good health as established by multiple criteria
结局指标
主要结局
The proportion of participants free from symptomatic atrial fibrillation (AF) or symptomatic atypical atrial flutter/atrial tachycardia (AFL/AT) lasting longer than 30 seconds post the 90 day blanking period
时间窗: Day 91 through 12 months
The outcome will be assessed from 91 days post procedure through 12 months
次要结局
未报告次要终点