Clinical Validation of the AIMIGo 12 Lead ECG Synthesis Software for Arrhythmia Detection: A Prospective Multicenter Pivotal Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 9
- 主要终点
- Clinical equivalence of ECG amplitudes compared between AIMIGo Synthesized 12L and reference standard 12L
研究概览
简要总结
The study is a prospective single-arm multicenter clinical trial. Adult patients will be consented and enrolled in an outpatient cardiology office or Arrhythmia Clinics.
详细描述
The purpose of this study is to conduct clinical validation of the AIMIGo 12-lead Synthesis Software against a standard FDA-cleared 12-lead ECG system, based on quantitative and qualitative assessment of paired recordings from the same patient, in sinus rhythm or during episodes of symptomatic non-life-threatening arrhythmia. The study will provide the necessary data for an FDA 510(k) regulatory submission and develop experience for market access and integration into clinical workflows.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Male or female subjects over 18 years of age.
- •Referred to outpatient arrhythmia clinic with a history of one or more of the following conditions:
- •Previous diagnosis of arrhythmia presenting to the clinic for routine follow-up evaluation.
- •Patients with symptoms indicative of cardiac arrhythmias.
- •Able and willing to sign informed consent.
排除标准
- •Open chest wounds or recent (<30 days) surgery to the chest or abdomen.
- •Clinical conditions that in the opinion of the Investigator would compromise the safety of the patient or ability to complete the protocol.
结局指标
主要结局
Clinical equivalence of ECG amplitudes compared between AIMIGo Synthesized 12L and reference standard 12L
时间窗: 30 seconds recording
Quantitative analysis on ECG amplitudes of the median beat of a 30s simultaneously recorded ECG from study and reference device.
Clinical equivalence of ECG intervals compared between AIMIGo Synthesized 12L and reference standard 12L
时间窗: 30 seconds recording
Quantitative analysis on ECG intervals of the median beat of a 30s simultaneously recorded ECG from study and reference device.
次要结局
- Clinical diagnostic accuracy of AIMIGo Synthesized 12L compared with the reference standard 12L ECG for the classification of arrhythmia.(30 seconds recording)