Tracking Results of Ablations to Combat AF Registry Generation 2
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 50
- 主要终点
- Patient's AF burden 6-month after receiving the ablation procedure
研究概览
简要总结
The primary objective of the TRAC-AF Registry is to capture real-world safety and effectiveness data on AtriCure devices used to conduct open concomitant and/or hybrid ablation, and management of the LAA concomitant to a cardiac ablation.
详细描述
Up to 10,000 patients at up to 250 sites. Participating regions may include US, Canada, Europe, Asia Pacific and others to be determined. Registry participating sites will enroll patients that meet all inclusion criteria and no exclusion criteria without preselection or bias. Each patient will be followed for a period of up to ten (10) years after their procedure according to the standard practice at the enrolling center. There will be no additional visits, nor procedures, for subjects who participate in the registry.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Patient has been scheduled by physician(s) to undergo or has undergone cardiac ablation procedure(s)
- •Patient is willing to provide informed consent
- •Patient whose age is 18 years or above, or of legal age to give informed consent specific to state and national law
排除标准
- •1. Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol.
结局指标
主要结局
Patient's AF burden 6-month after receiving the ablation procedure
时间窗: 6 months
Collect patient data on Atrial Fibrillation burden after the ablation procedure as documented by long term event monitoring or identified during the exam after a six-month recovery period.
Adverse events of the ablation procedure as atrial fibrillation management
时间窗: 1 year
Collect data on adverse events occurred during and post operation to assess the safety of the ablation procedure.
次要结局
未报告次要终点