A Multi-Center, Prospective, Open Label Clinical Trial to Evaluate Impact of Extended Electrocardiographic Monitoring Using MEMO Patch Plus in Patients With Acute Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 3
- 主要终点
- Percentage of Participants With Clinically Significant Arrhythmias Detected by MEMO Patch Plus
研究概览
简要总结
This prospective, multicenter, open-label, single-group exploratory clinical trial evaluates the clinical effectiveness of extended electrocardiographic monitoring with MEMO Patch Plus for detecting clinically significant arrhythmias in adult patients hospitalized with acute heart failure.
Eligible participants receive continuous electrocardiographic monitoring with MEMO Patch Plus for up to 14 days during hospitalization and again for up to 14 days after discharge. Participants return the post-discharge device by mail, review the monitoring results approximately 6 weeks after discharge, and complete a final follow-up assessment approximately 12 weeks after discharge.
The primary outcome is the proportion of participants in whom a clinically significant arrhythmia is detected. Secondary outcomes include the detection of other arrhythmias, changes in clinical management following an arrhythmia diagnosis, major clinical events through 3 months after discharge, atrial fibrillation or atrial flutter burden, the longest atrial fibrillation or atrial flutter episode, and adherence to MEMO Patch Plus monitoring.
详细描述
Background
Clinically significant arrhythmias frequently coexist with acute heart failure and may contribute to hemodynamic instability, worsening heart failure, stroke, cardiac arrest, intensive care unit admission, and death. Although continuous electrocardiographic monitoring may allow earlier detection of arrhythmias, evidence regarding the appropriate method and duration of monitoring in patients with acute heart failure who are not receiving intensive care remains limited.
MEMO Patch Plus is a wearable patch-type electrocardiographic monitoring device that continuously records electrocardiographic signals for up to 14 days. This study is designed to evaluate the feasibility and clinical effectiveness of extended electrocardiographic monitoring using MEMO Patch Plus in patients hospitalized with acute heart failure.
Study Design and Population
This is a prospective, multicenter, open-label, single-group exploratory clinical trial. Approximately 46 male and female participants aged 19 years or older who are hospitalized for acute heart failure will be enrolled.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participant aged 19 years or older
- •Participant who voluntarily agrees to participate in the clinical trial and provides written informed consent
- •Participant who is hospitalized for acute heart failure
- •Acute heart failure is defined as worsening signs or symptoms of heart failure requiring an unplanned hospital admission or emergency department visit.
排除标准
- •Participant who is unable to make a voluntary decision regarding participation in the clinical trial
- •Participant who is currently admitted to an intensive care unit
- •Participant diagnosed with any of the following clinically significant arrhythmias on the initial standard 12-lead electrocardiogram obtained after presentation:
- •A pause lasting 3 seconds or longer
- •High-degree atrioventricular block or complete atrioventricular block
- •Atrial fibrillation or atrial flutter
- •Supraventricular tachycardia, including atrial tachycardia and paroxysmal supraventricular tachycardia
- •Ventricular tachycardia
- •Ventricular fibrillation
- •Participant with a psychiatric disorder, including cognitive impairment or dementia, or a social circumstance that, in the investigator's judgment, may interfere with compliance with the clinical trial
- •Participant with a history of an allergic skin reaction to external medical electrodes or equivalent materials
- •Participant with a life expectancy of less than 3 months, as determined by the investigator
研究组 & 干预措施
MEMO Patch Plus Monitoring Group
Participants hospitalized with acute heart failure receive extended electrocardiographic monitoring with MEMO Patch Plus.
Participants wear MEMO Patch Plus during hospitalization for up to 14 days and return the device by Visit 2, no later than Day 15. At discharge, participants receive another MEMO Patch Plus device and wear it for up to 14 additional days in the outpatient setting. The post-discharge device is returned by mail.
Participants review the complete monitoring results at approximately 6 weeks after discharge and complete a final follow-up assessment at approximately 12 weeks after discharge.
干预措施: MEMO Patch Plus (Device)
结局指标
主要结局
Percentage of Participants With Clinically Significant Arrhythmias Detected by MEMO Patch Plus
时间窗: During inpatient monitoring for up to 14 days and post-discharge monitoring for up to 14 days
The number and percentage of participants with at least one clinically significant arrhythmia detected during extended electrocardiographic monitoring with MEMO Patch Plus will be assessed. Clinically significant arrhythmias are defined as: * A pause lasting 3 seconds or longer * High-degree atrioventricular block or complete atrioventricular block * Atrial fibrillation or atrial flutter * Supraventricular tachycardia, including atrial tachycardia and paroxysmal supraventricular tachycardia * Ventricular tachycardia * Ventricular fibrillation The number and percentage of participants with each type of clinically significant arrhythmia will also be summarized.
次要结局
- Percentage of Participants With Other Arrhythmias Detected by MEMO Patch Plus(From the first MEMO Patch Plus application through 12 weeks after discharge)
- Percentage of Participants With Changes in Clinical Management Following an Arrhythmia Diagnosis(From the first MEMO Patch Plus application through 12 weeks after discharge)
- Number and Percentage of Participants With Major Clinical Events(From discharge through 12 weeks after discharge)
- Atrial Fibrillation or Atrial Flutter Burden(During inpatient monitoring for up to 14 days and post-discharge monitoring for up to 14 days)
- Duration of the Longest Atrial Fibrillation or Atrial Flutter Episode(During inpatient monitoring for up to 14 days and post-discharge monitoring for up to 14 days)
- Actual Wear Time of MEMO Patch Plus After Discharge(During post-discharge monitoring for up to 14 days)
- Percentage of Interpretable Electrocardiographic Recording(During post-discharge monitoring for up to 14 days)