AI-ECG Accessory Pathway Localisation Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Performance and accuracy of the AI-ECG accessory pathway localisation algorithm
研究概览
简要总结
This study seeks to validate the real-world accuracy of an AI-based algorithm for identifying the location of an accessory pathway from the 12-lead electrocardiogram
详细描述
Silent validation study of an AI-ECG (artificial intelligence applied to electrocardiography) accessory pathway localisation algorithm, applied to prospective and consecutive cases in clinical practice, to determine its true accuracy and performance.
A pre-existing AI-ECG algorithm will be applied to participant ECG data, collected at the time of their clinical electrophysiology study (EPS) for ablation of their accessory pathway. This will be compared to the ground truth of the successful ablation location, determined by fluoroscopy and/or 3D electroanatomical mapping from their 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
- 13 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referred for EPS procedure as part of their clinical care, with a finding of pre-excitation on their ECG
- •Manifest pre-excitation on their ECG any time prior to their procedure
- •Able to give consent
- •Minimum age 13 years old
- •Maximum age 100 years old
排除标准
- •Unable to give consent
- •Adults > 100 years old
- •Children < 13 years old
- •Patients with known location of their accessory pathway from a previous EP study
结局指标
主要结局
Performance and accuracy of the AI-ECG accessory pathway localisation algorithm
时间窗: At completion of recruitment, anticipated at 18 months
Performance metrics of the AI-ECG accessory pathway localisation algorithm, including accuracy, F1-score, sensitivity, specificity, positive and negative predictive values. Benchmarked against the ground truth of human operator assessment from fluoroscopy and/or 3D electroanatomical mapping.
次要结局
- Accuracy of the ground truth locations from the human operator compared to the successful ablation location(At completion of recruitment, anticipated at 18 months)
- Relative performance of the AI-ECG algorithm compared to human estimation(At completion of recruitment, anticipated at 18 months)
- Relative performance of the AI-ECG algorithm compared to manual localisation algorithms(At completion of recruitment, anticipated at 18 months)