Post-Market Randomized Controlled Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation GuideD by Electroanatomical Mapping to Achieve Permanent Pulmonary Vein Isolation (En-GARDE)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- CardioFocus
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Rate of Permanent Pulmonary Vein Isolation of EAS-AC Compared to EAM Guided Radiofrequency Ablation
研究概览
简要总结
To compare the safety and chronic Pulmonary Vein isolation of 2 ablation types.
- visually guided ablation (VGA) using the EAS-AC and
- radiofrequency ablation
详细描述
The goal of the study was to compare two interventions, visually-guided endoscopic ablation to standard-of-care radiofrequency (RF) ablation. The study was terminated early by the Sponsor for business reasons before any participants were randomized or treated with RF ablation.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic, Paroxysmal Atrial Fibrillation (AF)
- •18 to 75 Years of age
- •Generally good overall health as determined by multiple criteria
- •Willing to participate in a study
排除标准
- 未提供
研究组 & 干预措施
Radiofrequency Ablation
PVI using RF ablation
干预措施: RF PVI Ablation (Device)
Visually Guided Ablation
PVI using visually guided ablation with an endoscopic ablation system
干预措施: Endoscopically guided PVI Ablation (Device)
结局指标
主要结局
Rate of Permanent Pulmonary Vein Isolation of EAS-AC Compared to EAM Guided Radiofrequency Ablation
时间窗: 3 Months
Number of initially isolated pulmonary veins that remain isolated at a 3 month remapping. The unit of measure is treated pulmonary veins (PVs).
次要结局
未报告次要终点