Home-based Videoplethysmographic Detection of Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 256
- 试验地点
- 2
- 主要终点
- Area Under the Receiver Operating Characteristic Curve (AUC) for the Detection of Atrial Fibrillation
研究概览
简要总结
The project focuses on the evaluation of a novel, contactless monitoring technology to measure the blood pulsatile signal based on the video recording of an individual's face. The variability of the pulse rate is computed to identify the presence of atrial fibrillation (AF). We propose to enroll 315 patients with symptomatic AF, paroxysmal or persistent, who go through successful radiofrequency ablation or electrical cardioversion. A computer tablet will be used by the subjects at home during 14 days after their procedure to read emails, browse the internet and watch videos. Facial video recordings will be automatically acquired during these daily activities by the tablet device. The subject will be wearing an ECG patch during the follow-up period. The one-lead continuous ECG will be used as a reference to verify the presence of AF rhythm during facial video recordings. The primary aim of the study is to demonstrate the validity and robustness of the video-based technology to detect the presence of AF when facial videos are acquired by the patients at home.
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
- •Men and women older than 18 years of age,
- •Medically-managed for symptomatic AF (persistent or paroxysmal),
- •In sinus rhythm after their ablation procedure,
- •In sinus rhythm after trans-thoracic electrical cardioversion.
排除标准
- •Implanted with a device (pacemaker, CRT, ICD) and a ventricular pacing requirement superior or equal to 70%,
- •Known allergic reaction to adhesives or hydrogels or with a family history of adhesive skin allergies,
- •Unable to cooperate with the protocol due to dementia, psychological, or other related reason,
- •Refusing to sign the consent for participation,
- •Unable to operate the device such as blind patients.
- •Patients with Parkinson disease (or other central nervous system disorder/Tremor) who cannot record a stable video signal of their face.
- •The subject was previously enrolled in the current study.
- •The subject wears clothing covering the face, or uses facial makeup that will interfere with the quality of facial recordings.
- •Subject does not have internet access at home and lacks the technology to participate.
结局指标
主要结局
Area Under the Receiver Operating Characteristic Curve (AUC) for the Detection of Atrial Fibrillation
时间窗: 2 weeks
The outcome measure is the AUC of the curve obtained from the ROC analysis. The curve is a combination of specificity and sensitivity of detecting atrial fibrillation. The range of the curve is 0.5-1.0 where 0.5 would be random detection of atrial fibrillation and 1.0 would be perfect performance.
次要结局
未报告次要终点
研究者
Jean-Philippe Couderc
Associate Professor
University of Rochester