Evaluation of an Ultraportable ECG Recording Device and Its Visualization Software for the Detection of Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 主要终点
- the ratio between the number of ECGWs that allowed a physician to make a rhythmic diagnosis (ECGW interpretable) and the total number of ECGWs recorded and visualized.
研究概览
简要总结
The purpose is to demonstrate the usefulness of WitCard and WitDisplayer in the diagnosis of AF but more generally in the qualification of the heart rhythm and the diagnosis of cardiac arrhythmias.
The main objective is therefore to demonstrate that at least 90 +/- 0.03% of ECGWs are interpretable by a physician and the primary endpoint will therefore be the ratio of the number of ECGWs that allowed a physician to make a diagnosis. rhythmic (ECGW interpretable) and the total number of ECGW recorded and viewed.
The clinical trial as part of the CE medical device certification process for secondary objectives and ancillary studies will be required to assess the diagnostic performance of the WitCard + WitDisplayer system, the quality of the ECGW recorded by the WitCard, the the safety of using the WitCard, the technical performance of the WitCard ECG recorder, the ergonomics of the WitCard, and finally the performance of automatic cardiac rhythm classification algorithms.
详细描述
Monocentric, prospective, interventional study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patient, male or female, over 18 years of age, presenting to the cardiology-rhythmology department (consultations and hospitalizations) or to the emergency department of the Timone 2 Hospital for the management of suspicion of disorder heart rate in front of:
- •Palpitations
- •Dyspnoea, acute pulmonary edema, non-ischemic heart failure
- •Malaise, lipothymia, syncope
排除标准
- •Patients with clinical criteria that do not warrant the use of WitCard:
- •Immediate vital risk whatever its nature
- •Rhythmic urgency requiring treatment without delay: respiratory, circulatory or neurological distress
- •Acute Coronary Syndrome
- •Pregnant women
- •Non-beneficiaries of a social security scheme
- •Persons deprived of their liberty
- •Patient participating in another study
- •Patient in a period of exclusion determined by a previous study
- •Patient under the protection of justice, under guardianship or under guardianship
研究组 & 干预措施
witcard
干预措施: the use of the WitCard (Device)
witcard
干预措施: the use of WitDisplayer (Other)
结局指标
主要结局
the ratio between the number of ECGWs that allowed a physician to make a rhythmic diagnosis (ECGW interpretable) and the total number of ECGWs recorded and visualized.
时间窗: 9 months
次要结局
未报告次要终点