A Post Market, Global Registry to Evaluate the Identification of Atrial Fibrillation Sources Using Electrographic Flow (EGF™) Mapping System to Guide Ablation Therapy in Patients With Atrial Fibrillation in Real-world Setting.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 5
- 主要终点
- Number of Participants With Acute Procedure Success
研究概览
简要总结
This post-market global registry will evaluate the ability of Electrographic Flow (EGF™) mapping to identify atrial fibrillation (AF) sources and guide ablation therapy in patients with atrial fibrillation in real-world setting.
详细描述
The AF-FLOW Registry is a prospective, multi-center global post-market registry that will obtain clinical data in order to characterize the performance of Electrographic Flow (EGF™) mapping with Ablamap® Software for its intended use in a real-world setting. Specifically, we will evaluate the ability of EGF mapping to identify sources of atrial fibrillation (AF) and guide ablation therapy in patients with atrial fibrillation. This registry will enroll up to 100 subjects. Subjects that present with AF and meet inclusion/exclusion criteria will be eligible for enrollment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Suitable candidate for intra-cardiac mapping and ablation of arrhythmias.
- •Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law.
- •Subjects with a history of documented symptomatic atrial fibrillation.
排除标准
- •Subjects who are not candidates for cardiac ablation procedures.
- •Pregnant or nursing.
- •Presence of anatomic or comorbid conditions, or other medical, social or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or comply with follow-up requirements.
结局指标
主要结局
Number of Participants With Acute Procedure Success
时间窗: During the procedure
Acute Procedure Success is defined as targeting and successful elimination of significant sources of electrographic flow (EGF) through radiofrequency ablation. EGF-identified sources are significant when their leading source activity is ≥ 26%. Successful elimination is defined as reduction of the source activity of the leading source to \<26% upon post-ablation remapping using EGF mapping.
次要结局
- Number of Participants With 12-month Freedom From AF Recurrence(90 day - 12 months)