Feasibility and Usability of a Chest-Strap Ambulatory ECG Monitor in Active Individuals in Comparison With a Traditional Ambulatory ECG Patch Monitor (MoMe ARC)
2026年9月14日 更新者：Elizabeth H. Dineen、Mayo Clinic
The purpose of this research is to compare the standard ambulatory ECG monitor, the MoMe ARC, against Fourth Frontier's "Frontier X Plus".
This device is an FDA-Cleared chest-strap-based ECG wearable that provides an alternative modality to capture ambulatory ECG rhythm changes.
研究概览
研究类型
观察性的
注册 (估计的)
15
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Elizabeth Dineen, DO
- 电话号码：904-953-5230
- 邮箱：dineen.elizabeth@mayo.edu
学习地点
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Arizona
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Scottsdale、Arizona、美国、85259
- 招聘中
- Mayo Clinic Arizona
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接触：
- Satyajit Reddy, MD
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Florida
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Jacksonville、Florida、美国、32224
- 招聘中
- Mayo Clinic Florida
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接触：
- Elizabeth Dineen, DO
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Minnesota
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Rochester、Minnesota、美国、55905
- 招聘中
- Mayo Clinic Rochester
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接触：
- Kathryn Larson, MD
- 电话号码：507-293-6358
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
Active adults older than 22 years who participate in moderate- to high-intensity exercise at least 4 days per week and more than 150 minutes per week total, and who have been prescribed ambulatory ECG monitoring for clinical purposes for 24 hours or more.
描述
Inclusion Criteria:
- Adult participants (>22 years; Frontier X is approved for use in this age group) who participate in >4 days a week of >150 minutes total per week of moderate to high intensity exercise who were prescribed a ambulatory ECG monitor for clinical purposes for 24 hours or more.
- Patients must agree to wear the Frontier X monitor for the prescribed duration and use the Frontier X Plus application
Exclusion Criteria:
- Current use of Implanted Cardiac Devices
- Pregnancy
- Known allergies to any of the materials listed in the "List of Patient-Contacting Materials"
- Presence of skin injuries or broken skin in the area where the chest strap is worn
- Inability to use a compatible mobile device required for the operation of the study device
- Any cognitive or physical limitations that, in the opinion of the investigator, limits the participant's ability to fully follow study procedures
- Medical restrictions on exercise for safety including cardiac, orthopedic or other relevant past medical history
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Active Adults Undergoing Ambulatory ECG Monitoring
Participants prescribed clinical ambulatory ECG monitoring will wear the Frontier X Plus chest-strap ECG device simultaneously with the MoMe ARC traditional ambulatory ECG monitor during their prescribed monitoring period and typical daily activities, including exercise.
|
The Frontier X Plus is a chest-strap-based wearable ECG device with embedded dry electrodes and a sensor that captures, stores, analyzes, and transmits ECG data through a mobile application and cloud-based platform for subsequent review.
The MoMe ARC monitor will be used as the traditional ambulatory ECG comparator and processed according to standard clinical workflows.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Concordance of Symptomatic Triggered Events Between Frontier X Plus and MoMe ARC
大体时间：24 hours
|
Automated Holter-style reports generated from the Frontier X Plus device will be compared with MoMe ARC reports.
Concordance will be assessed for symptomatic triggered events.
Results will be reported as the number of symptomatic triggered event findings for which the Frontier X Plus and MoMe ARC reports are in agreement.
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24 hours
|
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Concordance of Ventricular Tachycardia Episodes Greater Than 3 Beats Detected by Frontier X Plus and MoMe ARC
大体时间：24 hours
|
Automated Holter-style reports generated from the Frontier X Plus device will be compared with MoMe ARC reports.
Concordance will be assessed for ventricular tachycardia episodes greater than 3 beats.
Results will be reported as the number of ventricular tachycardia episode findings for which the Frontier X Plus and MoMe ARC reports are in agreement.
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24 hours
|
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Concordance of Supraventricular Tachycardia Episodes Greater Than 3 Beats Between Frontier X Plus and MoMe ARC
大体时间：24 hours
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Automated Holter-style reports generated from the Frontier X Plus device will be compared with MoMe ARC reports.
Concordance will be assessed for supraventricular tachycardia episodes greater than 3 beats.
Results will be reported as the number of supraventricular tachycardia episode findings for which the Frontier X Plus and MoMe ARC reports are in agreement.
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24 hours
|
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Total Time in Atrial Fibrillation Detected by Frontier X Plus and MoMe ARC
大体时间：24 hours
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Automated Holter-style reports generated from the Frontier X Plus device will be compared with MoMe ARC reports.
Total time in atrial fibrillation will be assessed for each device and reported as the cumulative duration of atrial fibrillation detected during the concordant monitoring period.
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24 hours
|
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Concordance of Premature Atrial Contraction Counts Between Frontier X Plus and MoMe ARC
大体时间：24 hours
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Automated Holter-style reports generated from the Frontier X Plus device will be compared with MoMe ARC reports.
Concordance will be assessed for premature atrial contraction counts.
Results will be reported as the number of premature atrial contraction count findings for which the Frontier X Plus and MoMe ARC reports are in agreement.
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24 hours
|
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Concordance of Premature Ventricular Contraction Counts Between Frontier X Plus and MoMe ARC
大体时间：24 hours
|
Automated Holter-style reports generated from the Frontier X Plus device will be compared with MoMe ARC reports.
Concordance will be assessed for premature ventricular contraction counts.
Results will be reported as the number of premature ventricular contraction count findings for which the Frontier X Plus and MoMe ARC reports are in agreement.
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24 hours
|
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Atrial Fibrillation Burden Detected by Frontier X Plus and MoMe ARC
大体时间：24 hours
|
Automated Holter-style reports generated from the Frontier X Plus device will be compared with MoMe ARC reports.
Atrial fibrillation burden will be assessed for each device and reported as the percentage of the concordant monitoring period during which atrial fibrillation was detected.
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24 hours
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：Elizabeth Dineen, DO、Mayo Clinic
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2027年2月23日
研究完成 (估计的)
2027年2月23日
研究注册日期
首次提交
2026年8月14日
首先提交符合 QC 标准的
2026年8月14日
首次发布 (实际的)
2026年8月19日
研究记录更新
最后更新发布 (实际的)
2026年9月17日
上次提交的符合 QC 标准的更新
2026年9月14日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 25-012842
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
是的
在美国制造并从美国出口的产品
是的
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.