CART Phase 3 Study: Diagnostic Performance of a Ring-type Wearable Device Using Deep Learning Analysis of Photoplethysmographic Signals for Detecting Atrial Fibrillation Among Ambulatory Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Diagnostic performance
研究概览
简要总结
This study investigates diagnostic performance of a ring-type wearable device for detecting atrial fibrillation. This is a prospective cohort registry study began after the date of IRB approval and until 31th Dec. 2023. The eligible criteria are (1) those who admitted the institution for elective direct-current cardioversion or catheter ablation of persistent atrial fibrillation, (2) those who were successfully converted to sinus rhythm after the intervention, and (3) aged 19 years or more. The exclusion criteria are (1) those aged less than 19 years, (2) those who are not converted to sinus rhythm after the intervention, and (3) those who are not eligible to measure photoplethysmographic signals. This study aims to recruit 100 participants in total. The participants are required to record photoplethysmographic signals by the ring device in addition to routine procedures of direct-current cardioversion or catheter ablation, hence, the study is at minimal risk.
详细描述
- Study title: Diagnostic Performance of a Ring-type Wearable Device Using Deep Learning Analysis of Photoplethysmographic Signals for Detecting Atrial Fibrillation Among Ambulatory Patients.
- Study type: Investigator initiated study.
- Study design: Prospective observational cohort registry design.
- Sponsor: Sky Labs, Inc., Republic of Korea.
- The aim of the study: To evaluate diagnostic performance of a ring-type wearable device for detecting atrial fibrillation among ambulatory patients.
- Study period: From the date of IRB approval to 31th Dec. 2023.
- The size of study population: 100 participants
- The eligibility criteria:
(1) Those with persistent atrial fibrillation (2) Those who admitted the institution for elective direct-current cardioversion or catheter ablation (3) Those who are successfully converted to sinus rhythm (4) Those aged 19 years or more
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The exclusion criteria:
-
Those with other forms of cardiac arrhythmias
-
Those aged less than 19 years
-
Those who are not eligible to perform electrical cardioversion or catheter ablation
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Those who are not converted to sinus rhythm after the intervention
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Procedures of the study
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those with persistent atrial fibrillation
- •Those who admitted for elective direct-current cardioversion or catheter ablation
- •Those who are successfully converted to sinus rhythm
- •Those who aged 19 years or more
排除标准
- •Those who aged less than 19 years
- •Those who had other types of cardiac arrhythmias
- •Those who are not eligible to perform electrical cardioversion or catheter ablation
- •Those who are not converted to sinus rhythm
结局指标
主要结局
Diagnostic performance
时间窗: 1 month (from the discharge to the next outpatient clinic)
Diagnostic performance of a ring-type wearable device for detecting atrial fibrillation (parameters including sensitivity, specificity, positive predictive value, negative predictive value).
次要结局
未报告次要终点
研究者
Eue-Keun Choi
Professor
Seoul National University Hospital