NCT03434964已完成不适用
Preliminary Evaluation of the AIFib Software in Real Time as a Medical Decision Aid for the Detection of Atrial Fibrillation Driver
Hospital St. Joseph, Marseille, France8 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2018年7月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 8
- 主要终点
- Software performance evaluation a posteriori
研究概览
简要总结
To evaluate the intraoperative effectiveness of the AIFIB software in real time in the detection of atrial fibrillation drivers during an ablation procedure.
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
- •Patients 18 years of age or older
- •Etiology in the following list:
- •Atrial fibrillation for which a conventional anatomical approach alone (pulmonary vein isolation) is not performed: persistent AF, long standing persistent AF paroxysmal AF (redo), paroxysmal AF
- •Atrial tachycardia de novo or secondary to AF ablation.
排除标准
- •Contraindication to AF ablation
- •Major bleeding disorder
结局指标
主要结局
Software performance evaluation a posteriori
时间窗: during the ablation procedure
real-time validation by the second operator of the correct detection of atrial fibrillation driver
次要结局
- Indirect evaluation of the clinical effectiveness of the software(during the ablation procedure)
研究者
研究点 (8)
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