NCT06282393Unknown不适用
The FibriCheck Data Registry
Qompium NV2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年1月31日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Alignment PPG measurement
研究概览
简要总结
The goal of this interventional clinical trial is to establish a comprehensive, structured database that includes photoplethysmography (PPG) measurements with simultaneously recorded electrocardiography (ECG) data to evaluate the FibriCheck Algorithm in patients with heart rhythm disorders.
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
- •At least 18 years old
- •Access to a smartphone to perform daily measurements
- •Ability to understand Dutch
- •Atrial Fibrillation diagnosis OR one of the following:
- •CHA2DS2-VASc score ≥2 (male) or ≥3 (female)
- •Underwent elective cardiac surgery
- •Known with:
- •Chronic obstructive pulmonary disease
- •Obstructive sleep apnea
- •Heart Failure
- •Hypertension
- •Previous stroke or transient ischaemic attack
- •Having palpitations and/or racing heart as symptoms
- •Other arrhythmia such as atrial flutter, premature atrial contractions (PAC), premature ventricular contractions (PVC)
排除标准
- •Individuals which are currently in follow-up with their physician, using the FibriCheck application
- •Individuals with unnaturally coloured fingers (i.e. tattoos, ink); this may weaken the signal and may interfere with the effectiveness of the device
- •Persons with conditions causing tremors or the inability to hold their hand still for at least 60 seconds (e.g. Parkinson or dementia) as, in this case, the device may not be able to accurately process a measurement
- •Persons with reduced blood flow in the fingertips (e.g. perniosis or severe callus formation) as the device may not be able to detect the intensity variations induced by the blood flow
- •Persons that have a disability to perform the measurements according to the instructions for use
- •Persons with cardiac pacemakers, implantable cardioverter-defibrillators, or other implanted electronic devices as these can control the natural heart rhythm
研究组 & 干预措施
FibriCheck recordings
Other
干预措施: FibriCheck recordings (Device)
结局指标
主要结局
Alignment PPG measurement
时间窗: 14 days
ECG-PPG alignment (RR-intervals)
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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