An Exploratory Study to Evaluate Diagnostic Accuracy of a 7-day Adhesive Patch Electrocardiographic Monitoring for Detecting Arrhythmia in Patients With Palpitation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Arrhythmia Detection
研究概览
简要总结
"This exploratory prospective clinical study aims to evaluate the diagnostic yield of a 7-day adhesive electrocardiographic (ECG) monitoring device (MEMO Patch) in detecting cardiac arrhythmias in patients presenting with palpitations.
Participants who require 24-hour Holter monitoring because of symptoms such as palpitations or dizziness will simultaneously wear a conventional 24-hour Holter monitor and the MEMO Patch. The Holter monitor will be removed after 24 hours, while the MEMO Patch will continue monitoring for a total of 7 days. ECG recordings will be evaluated by cardiologists after technical quality assessment. The study will assess arrhythmia detection, device-related skin adverse events, and participant usability and satisfaction."
详细描述
"Patients aged 19 years or older who visit the study site with symptoms suggestive of arrhythmia and require 24-hour ambulatory ECG monitoring will be screened after providing written informed consent.
At Visit 1, participants will simultaneously undergo conventional 24-hour Holter monitoring and 7-day ECG monitoring using the MEMO Patch. Participants will record the occurrence and timing of any symptoms in a symptom diary during the monitoring period.
The Holter monitor will be returned after 24 hours. Participants will continue wearing the MEMO Patch for an additional six days and return the device by mail after completion of the 7-day monitoring period.
After technical quality assessment, ECG recordings from both devices will be interpreted by cardiologists. Participants will return approximately one week after completion of monitoring to review the test results. Device usability and participant satisfaction will also be assessed using a questionnaire."
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
盲法说明
No masking was applied to participants or investigators.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all of the following criteria:
- •Adults aged 19 years or older who visit the study site during the study period with symptoms such as palpitations or syncope and are considered to require 24-hour ambulatory electrocardiographic monitoring.
- •Able and willing to provide voluntary written informed consent.
- •Able to wear the MEMO Patch™ continuously for 7 days.
排除标准
- •Participants meeting any of the following criteria will be excluded:
- •A self-reported history of an allergic skin reaction to previously used adhesive products.
- •Planned electrical cardioversion, catheter ablation, or surgical treatment for an arrhythmia during the study period.
研究组 & 干预措施
MEMO Patch with 24-Hour Holter Monitoring
Participants simultaneously underwent conventional 24-hour Holter monitoring and continuous ECG monitoring using the MEMO Patch for seven days.
干预措施: MEMO Patch (Device)
MEMO Patch with 24-Hour Holter Monitoring
Participants simultaneously underwent conventional 24-hour Holter monitoring and continuous ECG monitoring using the MEMO Patch for seven days.
干预措施: 24-Hour Holter Monitor (Device)
结局指标
主要结局
Arrhythmia Detection
时间窗: Visit 3 (approximately 14 [±3] days after device application at Visit 1)
The presence of at least one of the following clinically significant arrhythmias as determined by ECG monitoring: Supraventricular tachycardia (≥3 consecutive beats, excluding atrial fibrillation/flutter) Atrial fibrillation/flutter (episode ≥30 seconds) Sinus pause (≥3 seconds) Second-degree (Mobitz type II) or third-degree atrioventricular block Ventricular tachycardia (≥3 consecutive beats) Polymorphic ventricular tachycardia or ventricular fibrillation
Rate of Participants with Clinically Significant Arrhythmia
时间窗: Visit 3 (approximately 14 [±3] days after device application at Visit 1)
The rate of participants diagnosed with at least one clinically significant arrhythmia will be evaluated based on ECG monitoring. Clinically significant arrhythmias include supraventricular tachycardia (≥3 consecutive beats, excluding atrial fibrillation/flutter), atrial fibrillation/flutter (episode ≥30 seconds), sinus pause (≥3 seconds), second-degree (Mobitz type II) or third-degree atrioventricular block, ventricular tachycardia (≥3 consecutive beats), and polymorphic ventricular tachycardia or ventricular fibrillation.
次要结局
- MEMO Patch Satisfaction and Usability Questionnaire(Visit 3 (approximately 14 [±3] days after device application at Visit 1))
- Frequency of Skin Adverse Events(Visit 3 (approximately 14 [±3] days after device application at Visit 1))
- MEMO Patch Satisfaction and Usability Questionnaire Score(Visit 3 (approximately 14 [±3] days after device application at Visit 1))