A Ring-type Wearable Device for Atrial Fibrillation
2020年3月16日 更新者:Eue-Keun Choi、Seoul National University Hospital
CART Phase 2 Study: Diagnostic Performance of a Ring-type Wearable Device Using Deep Learning Analysis of Photoplethysmographic Signals for Detecting Atrial Fibrillation
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. 2019.
The eligible criteria are (1) those who admitted the institution for elective direct-current cardioversion of persistent atrial fibrillation, and (2) aged 19 years or more.
The exclusion criteria are (1) those aged less than 19 years, (2) those who are not eligible to perform cardioversion by any reasons.
This study aims to recruit 200 participants in total.
The participants are required to record photoplethysmographic signals by the ring device in addition to routine procedures of direct-current cardioversion, hence, the study is at minimal risk.
研究概览
地位
未知
条件
详细说明
- Study title: Diagnostic Performance of a Ring-type Wearable Device Using Deep Learning Analysis of Photoplethysmographic Signals for Detecting Atrial Fibrillation.
- 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.
- Study period: From the date of IRB approval to 31th Dec. 2019.
- The size of study population: 200 participants
- The eligibility criteria:
(1) Those with persistent atrial fibrillation (2) Those who admitted the institution for elective direct-current cardioversion (3) Those aged 19 years or more 9. The exclusion criteria:
(1) Those with other forms of cardiac arrhythmias (2) Those aged less than 19 hears (3) Those who are not eligible to perform electrical cardioversion 10. Procedures of the study
- A participant is under the routine procedures of direct-current cardioversion.
- On admission, a participant is given with detailed information of the study.
- After the informed consent, the only additional procedure due to the study is recording photoplethysmographic signal by wearing a ring-type device.
- Recorded signals are evaluated without encompassing persornal information. 11. Financial benefits to the participants: None.
研究类型
观察性的
注册 (预期的)
200
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Seoul、大韩民国、03080
- Seoul National university Hostpital
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
19年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
The study consecutively recruits participants who admitted for elective direct-current cardioversion due to persistent atrial fibrillation.
描述
Inclusion Criteria:
- Those with persistent atrial fibrillation
- Those who admitted for elective direct-current cardioversion
- Those who aged 19 years or more
Exclusion Criteria:
- Those who aged less than 19 years
- Those who had other types of cardiac arrhythmias
- Those who are not eligible to perform electrical cardioversion
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Diagnostic performance
大体时间:Baseline
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Diagnostic performance of a ring-type wearable device for detecting atrial fibrillation (parameters including sensitivity, specificity, positive predictive value, negative predictive value).
|
Baseline
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员:Eue-Keun Choi, MD, PhD、Devision of Cardiology, Department of Internal Medicine, Seoul National University Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年1月23日
初级完成 (预期的)
2020年8月30日
研究完成 (预期的)
2020年12月31日
研究注册日期
首次提交
2019年7月15日
首先提交符合 QC 标准的
2019年7月15日
首次发布 (实际的)
2019年7月17日
研究记录更新
最后更新发布 (实际的)
2020年3月18日
上次提交的符合 QC 标准的更新
2020年3月16日
最后验证
2020年3月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
未定
IPD 计划说明
Currently, according to the decision with IRB of the institution, the IPD is not planned to be shared with other researchers for the purpose of protecting potential privacy issues of the participants.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.