Enhanced Diagnostics for Early Detection of Atrial Fibrillation - Prospective Validation (DETECTAF-pro)
研究概览
详细说明
Introduction This algorithm was validated earlier in a clinical trial with retrospective Data. The results were published accordingly.The algorithm is implemented in the commercial App Preventicus Heartbeats. DETECT AF is designed as prospective follow up trial.
Study design Prospective, blinded, multicenter international trial.
Methods
The subjects will be asked to position a smartphone on their index finger to allow their pulse curve to be recorded for five minutes. At the same time, an ecg will be recorded using an digital mobile ecg recorder as a reference.
Data will be collected on person-related information, comorbidities and medication (estimated overall duration/patient <20 min). No follow-up is planned. Analogous to predecessor studies, the pulse wave curve data are coded with the patient's identification number (ID) and externally analyzed at Preventicus; based on the results, the subjects will be assigned to SR/AF groups. After evaluation of all files, the grouped results will be aggregated, unblinded and evaluated under monitoring.
Primary target parameters are the app's sensitivity and specificity in correctly detecting atrial fibrillation compared to an automatically interpreted ECG.
Secondary target parameters include the proportion of non-evaluable recordings in the overall study.
研究类型
注册 (实际的)
联系人和位置
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Subjects of legal age,
- patients with either sinus rhythm (Group SR) or atrial fibrillation (Group AF)
- informed consent
Exclusion Criteria:
- Legally incompetent persons
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
---|---|
AF
Five minutes puls wave recording will be performed in patients in atrial fibrillation at time of recruitment
|
iPhone will be positioned on the index finger for five minutes to record a pulse wave
|
SR
Five minutes puls wave recording will be performed in patients in sinus rhythm at time of recruitment
|
iPhone will be positioned on the index finger for five minutes to record a pulse wave
|
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 |
---|---|---|
Correct detection of atrial fibrillation
大体时间:5 minutes
|
iPhone will be positioned on the index finger for five minutes to record a pulse wave; Algorithm should correctly differentiate between AF patients and SR patients
|
5 minutes
|
合作者和调查者
调查人员
- 首席研究员:Jens Eckstein, MD, PhD、Universityhospital Basel
出版物和有用的链接
一般刊物
- Krivoshei L, Weber S, Burkard T, Maseli A, Brasier N, Kuhne M, Conen D, Huebner T, Seeck A, Eckstein J. Smart detection of atrial fibrillationdagger. Europace. 2017 May 1;19(5):753-757. doi: 10.1093/europace/euw125.
- Brasier N, Raichle CJ, Dorr M, Becke A, Nohturfft V, Weber S, Bulacher F, Salomon L, Noah T, Birkemeyer R, Eckstein J. Detection of atrial fibrillation with a smartphone camera: first prospective, international, two-centre, clinical validation study (DETECT AF PRO). Europace. 2019 Jan 1;21(1):41-47. doi: 10.1093/europace/euy176.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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