Evaluation of a Digital Care System in the Follow-Up Care of Atrial Fibrillation Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- iATROS GmbH
- 入组人数
- 270
- 试验地点
- 3
- 主要终点
- Superiority of the iATROS platform as compared to the standard of care
研究概览
简要总结
The present study aims to investigate whether care improvement in patients after catheter ablation/cardioversion compared with standard care can be realized by using a digital eHealth platform with connected mobile sensors through early detection of atrial fibrillation recurrence and patient empowerment.
详细描述
The main objective of the study is to compare the reliability of detection of atrial fibrillation of 2 measurement methods or protocols in terms of earliest possible detection: (1) digital eHealth platform with tethered 1-lead ECGs vs (2) standard-of-care long-term ECG. In addition, the quality of the acquired ECGs with both protocols will be compared by physician reporting based on the number of false positive abnormal findings as well as possible effects of using different mobile 1-lead ECGs.
Secondary goals are the collection of data on patient adherence (e.g., reliability of performing recommended actions such as measuring ECGs, blood pressure and body weight, and taking medications), on the course of the disease, and on the use of the health care system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years
- •Diagnosis of atrial fibrillation according to ICD-10 I48.0, I48.1, I48.2, or I48.
- •Catheter ablation or cardioversion no more than 72 hours ago at the time of inclusion.
- •Possession and use of a smartphone that allows installation and use of the iATROS app.
- •Possession of the physical and mental abilities to use and apply the iATROS app.
- •Patients undergoing ablation or cardioversion after a confirmed diagnosis of atrial fibrillation.
排除标准
- •< 18 years
- •No use of a smartphone
- •Lack of the physical and mental abilities necessary to use the iATROS app, or to use so-called "apps" on a smartphone or tablet computer in general
- •Absolute contraindications:
- •Tumor disease
- •immunosuppression
- •Dementia in an advanced stage
- •Any disease associated with a reduced life expectancy of less than 1 year
- •Any disease/condition that restricts participation in the study
- •Pregnant or breastfeeding patients
- •Participation in another clinical trial
- •Addictive diseases
- •Stroke in the last 3 months
- •Transient ischemic attack (TIA) in the last 3 months
研究组 & 干预措施
Digital eHealth platform with connected mobile 1-lead ECGs + Standard of Care
Patients will be fitted with a 1-channel ECG monitor after inclusion in the study and discharged to post ablation care. Here, ECGs are recorded regularly until the occurrence of an arrhythmic event. After the occurrence of an event, a discussion with the investigator will be performed. Interim medical contacts will be limited to the agreed-upon follow-up appointments for the long-term ECGs and other appointments routinely scheduled in the patient's care according to the Standard of Care.
long-term ECGs at defined time points
干预措施: iATROS (Device)
结局指标
主要结局
Superiority of the iATROS platform as compared to the standard of care
时间窗: 12 months to a maximum of 24 months
Assessment of atrial fibrillation recurrences and attribution to detection system. Clinically relevant superiority of one system over the other is defined at an allocation of ≥75% of all arrhythmic events to either system.
次要结局
未报告次要终点