Optimizing Diagnostics And Therapy Of Arrhythmia And Syncope Events Using Intelligent Telemetric Solutions. Diagnostics Of Arrhythmia In Children
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 6
- 主要终点
- Recording of symptomatic or life threatening arrhythmia event
研究概览
简要总结
The purpose of this study is to assess efficacy of prolonged Full Disclosure electrocardiogram (ECG) monitoring and signal analysis using advanced telemetric technology to diagnose arrhythmia in comparison with standard diagnostic procedure.
详细描述
Irregular and/or rapid beating of the heart called heart palpitations can occur in individuals without heart disease and the reasons for their palpitations are unknown. Together with heart palpitations silent arrhythmia may be present that could lead to serious complications (eg. stroke). In others, palpitations result from heart rhythm disturbances, sometimes life threatening. Standard diagnostic methods such as 24 hours Holter electrocardiogram (ECG) monitoring or Event Holter do not guarantee early diagnosis of the arrhythmia. Prolonged heart rhythm recording and analysis using an automatic full disclosure telemetric device can increase probability of arrhythmia diagnosis and early administration of applicable treatment. Study patients will be diagnosed using standard Holter ECG monitoring, Event Holter or 30 days telemetric ECG monitoring. Efficacy of telemetric monitoring in diagnosis of cardiac arrhythmia will be assessed in comparison with the standard Holter monitoring and Event Holter
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of symptoms that can be potentially caused by cardiac arrhythmia occuring at least 4 times a year
- •Ability to operate the telemetric device at home
- •Informed consent undersigned by the parents
- •Informed consent undersigned by the child if over 16 years of age
排除标准
- •Previously recorded tachycardia evidence
- •Wolff Parkinson White syndrome
- •Inability to operate the telemetric device at home
- •Inability to comply with the study protocol
结局指标
主要结局
Recording of symptomatic or life threatening arrhythmia event
时间窗: within 30 days since the start of monitoring
ECG monitoring is conducted until occurrence of symptomatic arrhythmia or life threatening arrhythmia but not longer than 30 days. Patients in the control group will have standard ECG Holter monitoring repeated twice
次要结局
- Occurrence of silent (asymptomatic) arrhythmia event(within 30 days since the start of monitoring)
- Verification of patient self assessment based on the Quality of Life questionnaire and European Heart Rhythm Association (EHRA) scale against evidence of cardiac arrhythmia occurrence(within 30 days since the start of monitoring)