Validation of an iPhone-based Event Recorder for Arrhythmia Detection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Validation of an iPhone-based Event Recorder for Arrhythmia Detection
研究概览
简要总结
In this study, we will evaluate the diagnostic yield of the new AliveCor device versus a 14 day event monitor with the use of both devices simultaneously. We will also examine by means of a questionnaire the compliance, ease of use and patient satisfaction for each device.
Hypothesis:
- The AliveCor monitor will be non-inferior to the 14 day event monitor with respect to diagnosis of the arrhythmia responsible for a patient's symptoms.
- The AliveCor monitor will have better compliance and acceptability compared to the 14 day event monitor, and thus there will be a greater number of days with recordings from the AliveCor monitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patients >18 years of age with symptoms such as palpitations or pre-syncope suggestive of arrhythmias (usually occurring less frequently than once a day) with prior non-diagnostic ECGs and/or Holter monitoring.
- •Patients who own an iPhone 4, 4S or 5 device and demonstrate the capability of recording and uploading a test ECG recording at the office visit.
排除标准
- •Patients <18 years of age.
- •Patients with a myocardial infarction (MI) within the last three months, and/or known history of sustained VT/VF.
- •Patients with NYHA class IV heart failure.
- •Patients with unstable angina.
- •Patients with syncope as the presenting symptom.
- •Patients unable to or unwilling to use the device.
研究组 & 干预措施
Alivecor device and event monitor
Both the Alivecor device (experimental) and the standard of care (event monitor) will be provided to all patients for the duration of the study
干预措施: Alivecor monitor and 14 day event monitor (Device)
结局指标
主要结局
Validation of an iPhone-based Event Recorder for Arrhythmia Detection
时间窗: one year
For the primary endpoint, equivalence testing using the two one-sided test (TOST) procedure was used to compare the proportion of unpaired days in which a diagnostic recording was made with each device during the monitoring period. A difference of less than 10% between the devices on the rate of detection of arrhythmias was taken to indicate equivalence.
次要结局
未报告次要终点
研究者
Deepika Narasimha
MD
University at Buffalo