ADVENT Trial Long Term Outcomes Evaluating Atrial Fibrillation Progression (ADVENT LTO Study)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 356
- 试验地点
- 50
- 主要终点
- Chronic success in ADVENT Trial treated subjects compared between treatment groups.
研究概览
简要总结
The (ADVENT LTO) is an observational, non-significant risk study to assess the progression of atrial fibrillation in subjects who received ablation treatment with either the FARAPULSE Pulsed Field Ablation System or thermal ablation in the ADVENT Trial.
详细描述
This study is an observational, non-significant risk study. Subjects who participated in the FARAPULSE ADVENT Trial (NCT04612244) will be approached for participation.
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
- •Subjects who meet all of the following criteria may be given consideration for inclusion in this clinical investigation.
- •Subjects who were enrolled, randomized and treated for paroxysmal atrial fibrillation, classified as Modified Intention-to-Treat subjects, and completed the 12-Month Follow-Up in the FARAPULSE ADVENT Trial (CIP CS0934; NCT04612244).
- •Subjects or legally authorized representatives who are willing and capable of providing informed consent.
- •Subjects who are willing to comply with the protocol requirements.
排除标准
- •There are no exclusion criteria for this study.
结局指标
主要结局
Chronic success in ADVENT Trial treated subjects compared between treatment groups.
时间窗: 90 day-3 years
Occurrence of any of the following between the end of the Blanking Period (Day 90) in the ADVENT Trial through completion of follow-up in the ADVENT LTO study: Detectable AF, AFL+, or AT * ≥ 30 seconds in duration as adjudicated within the ADVENT Trial * Investigator assessed ≥ 30 seconds in duration from any approved clinical recording devices considered standard of care\* at the study center post-ADVENT Trial completion * ≥ 30 seconds in duration recorded on the Holter monitor collected during the ADVENT Trial and the 3-4 Year Holter Monitor. * ≥ 10-second of continuous AF, AFL or AT documented on any 12-lead ECG Any Cardioversion for AF, AFL, or AT Re-ablation for AF, AFL, or AT
次要结局
未报告次要终点