Atrial Fibrillation Detection Using MEMO Patch in Patients With Stroke of Unknown Cause: A Single-Center, Prospective, Exploratory Trial to Validate the Efficacy and Safety of Noninvasive Long-Term Electrocardiographic Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Detection rate of Atrial Fibrillation (%)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of a wearable device in detecting previously undiagnosed atrial fibrillation through non-invasive long-term monitoring using a wearable single-lead ECG patch (MEMO Patch M, MEMO Patch2) in 100 patients with Embolic Stroke of Undetermined Source (ESUS) who require atrial fibrillation screening. Participants who meet all inclusion and exclusion criteria and provide written informed consent will wear the MEMO Patch M and undergo in-hospital telemetry monitoring using MEMO Cue for a minimum of 12 hours and up to 8 days. During hospitalization, 24-hour Holter monitoring will also be conducted. Before discharge, the investigator will review these results to determine whether implantable loop recorder (ILR) implantation is necessary. At the time of discharge, participants will wear MEMO Patch2 for up to 14 days for the first ECG monitoring period. One month after discharge, the investigator will review the results of the first monitoring and initiate the second ECG monitoring with MEMO Patch2. Three months after discharge, the results of the second ECG monitoring will be reviewed, and participation in the clinical trial will be completed.
详细描述
This clinical study is designed as a prospective, single-center, investigator-initiated exploratory clinical trial.
- Screening Participants will be assigned a screening number in the order in which informed consent is obtained. Through interviews and review of previous medical records, demographic information, medical history, surgical/procedural history, prior medications, and other required assessment items will be collected. Eligibility for study participation will be determined by reviewing the inclusion and exclusion criteria.
- Visit 1 (In-Hospital Telemetry Monitoring) Eligible participants will be fitted with the investigational medical device, MEMO Patch M, and will undergo in-hospital telemetry monitoring using MEMO Cue for a minimum of 12 hours and up to 8 days. A 24-hour Holter monitor will also be applied after admission. Prior to discharge, participants will review the MEMO Patch M (in-hospital telemetry) results to determine whether ILR implantation is required.
- Discharge (First ECG Monitoring) At discharge, participants who were not detected with atrial fibrillation using the Holter ECG or MEMO Patch M will receive an Implantable Loop Recorder (ILR). Participants in whom atrial fibrillation is detected will not receive ILR implantation. Regardless of ILR implantation, all participants will wear MEMO Patch2 and undergo additional ECG monitoring for up to 14 days after discharge. After the scheduled monitoring period ends, MEMO Patch2 will be returned using the Huinno courier service.
- Visit 2 (Review of First ECG Monitoring Results - 1-Month Visit) At the 1-month outpatient visit, participants will review the results of the first ECG monitoring. They will then undergo a second monitoring period by wearing MEMO Patch2 for up to 14 days. After completing the scheduled monitoring period, MEMO Patch2 will be returned using the Huinno courier service.
- Visit 3 (Review of Second ECG Monitoring Results - 3-Month Visit) At the 3-month outpatient visit, participants will review the results of the second ECG monitoring. After this visit, participation in the clinical study will be completed.
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
- •Participants may take part in this clinical study only if they meet all of the following criteria:
- •Adults aged 19 years or older who voluntarily provide written informed consent to participate in the study
- •Patients diagnosed with ESUS (Embolic Stroke of Undetermined Source)
- •Patients who require in-hospital or out-of-hospital electrocardiographic (ECG) monitoring
排除标准
- •Participants who meet any of the following criteria cannot be enrolled in this clinical study:
- •Individuals already diagnosed with atrial fibrillation or atrial flutter
- •Individuals with a clearly identified cause of stroke
- •Individuals known to have allergic reactions to adhesives or hydrogels
- •Individuals who, in the investigator's judgment, have cognitive vulnerability that makes it difficult to understand the study information and voluntarily decide on participation
- •Any other individuals whom the principal investigator considers to be at potential risk by participating in the study or otherwise unsuitable for participation
研究组 & 干预措施
MEMO Patch Long-Term Monitoring(MEMO Patch M, MEMO Patch2)
Participants in this arm will undergo long-term ECG monitoring using MEMO Patch M during hospitalization and MEMO Patch2 after discharge. 24-hour Holter monitoring will also be performed, and ILR implantation will be assessed before discharge.
干预措施: MEMO Patch M and MEMO Patch2 (Device)
结局指标
主要结局
Detection rate of Atrial Fibrillation (%)
时间窗: During V1 (Day 0 to Day 8)
The detection rate of atrial fibrillation (AF) will be evaluated based on MEMO Patch M during telemetry monitoring and 24-hour Holter monitoring. The AF detection rate by MEMO Patch M will be calculated as the number and percentage of participants in whom AF is detected at least once either through alarms or analysis results. The AF detection rate by 24-hour Holter will be calculated as the number and percentage of participants in whom AF is detected at least once during Holter analysis. The final determination of atrial fibrillation will be made according to the investigator's interpretation.
次要结局
- Time of Atrial Fibrillation (AF) detection(30 days (+7 days) and 90 days (+7 days) post-discharge (discharge = up to Day 8))
- Accuracy of in-hospital monitoring alarms(During V1 (Day 0 to Day 8))
- AF detection rate and burden during out-of-hospital MEMO Patch2 monitoring(30 days (+7 days) and 90 days (+7 days) post-discharge (discharge = up to Day 8))
- Detection rate of non-AF arrhythmias(During V1 (Day 0-8), 30 days (+7 days) and 90 days (+7 days) post-discharge (discharge = up to Day 8))
- Analysis of arrhythmia types including AF(During V1 (Day 0-8), 30 days (+7 days) and 90 days (+7 days) post-discharge (discharge = up to Day 8))
- Risk factor analysis for AF occurrence(Screening (Day-28 to Day 0), 30 days (+7 days) and 90 days (+7 days) post-discharge (discharge = up to Day 8))
- Rate and timing of treatment strategy changes (Including medication and procedures) after AF diagnosis(During V1 (Day 0-8), 30 days (+7 days) and 90 days (+7 days) post-discharge (discharge = up to Day 8))
- Comparison of AF detection rates and timing between two monitoring strategies (MEMO Patch M + MEMO Patch2 vs. Holter + ILR)(During V1 (Day 0-8), 30 days (+7 days) and 90 days (+7 days) post-discharge (discharge = up to Day 8))
研究者
Bum Joon Kim
Principal Investigator
Asan Medical Center