Comparison of 7-Day ECG Patches
2026年6月22日 更新者：Medical University Innsbruck
Comparison of Commercially Available 7-Day ECG Patches: A Randomized Study
This prospective, randomized, multi-arm study evaluates the usability and performance of commercially available CE-certified 7-day ECG patches in an outpatient setting.
Participants aged ≥65 years requiring ECG monitoring as part of routine care will be randomized to one of six ECG patch devices.
The study aims to assess the proportion of analyzable ECG recordings and overall recording quality over a 7-day period.
研究概览
地位
主动，不招人
详细说明
Atrial fibrillation is a common arrhythmia often underdiagnosed due to its intermittent nature. Long-term ECG monitoring using wearable patch devices has emerged as an important diagnostic tool. However, comparative data between available devices are lacking.
This randomized study compares six commercially available ECG patches regarding usability, adherence, and recording quality in an elderly outpatient population. Participants will independently apply the assigned device and undergo 7-day ECG monitoring. Device performance and patient feedback will be systematically assessed.
研究类型
介入性
注册 (实际的)
150
阶段
- 不适用
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。
学习地点
-
-
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Innsbruck、奥地利、6020
- Medical University Innsbruck
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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
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
- Age 65 years or older and residing in private homes
- ECG patch intended for use as part of routine clinical practice
- Written informed consent
Exclusion Criteria:
- Allergies to adhesive materials
- Participation in another randomized trial
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
- 主要用途：诊断
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Smartcardia 7L Patch
Participants randomized to this arm will receive the Smartcardia 7L ECG patch for a 7-day monitoring period and will apply the device independently according to instructions.
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CE-certified multi-parameter ECG patch including additional physiological monitoring
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实验性的：ECG247
Participants randomized to this arm will receive the ECG247 ECG patch for a 7-day monitoring period and will apply the device independently according to instructions.
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CE-certified ECG patch with smartphone-based data transmission.
|
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实验性的：HeartX Recorder
Participants randomized to this arm will receive the HeartX Recorder for a 7-day monitoring period and will apply the device independently according to instructions.
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CE-certified ECG patch designed for long-term continuous rhythm monitoring.
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实验性的：Kardiobeat
Participants randomized to this arm will receive the Kardiobeat patch for a 7-day monitoring period and will apply the device independently according to instructions.
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CE-certified multi-lead ECG patch for continuous cardiac monitoring
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实验性的：net_ECG
Participants randomized to this arm will receive the net_ECG patch for a 7-day monitoring period and will apply the device independently according to instructions.
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CE-certified 3 lead ECG patch designed for long-term continuous rhythm monitoring.
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实验性的：ZIO Patch
Participants randomized to this arm will receive the ZIO Patch for a 7-day monitoring period and will apply the device independently according to instructions.
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CE-certified single-lead ECG patch for long-term continuous rhythm monitoring
|
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 |
|---|---|---|
|
Proportion of participants with analyzable ECG recording ≥24 hours
大体时间：7 days
|
The proportion of participants who achieve at least 24 hours of analyzable ECG recording during the 7-day monitoring period.
Analyzable ECG recording is defined as ECG data of sufficient technical quality to allow rhythm assessment, as determined by the certified analysis algorithm provided by the device manufacturer.
Periods with insufficient signal quality (e.g., due to noise, signal loss, or artifacts) are excluded.
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7 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cumulative analysable ECG time
大体时间：7 days
|
Cumulative duration, in hours, of analysable ECG obtained per participant during the intended 7-day monitoring period, where analysable ECG is defined as ECG of sufficient quality, according to the manufacturer's signal-quality criteria, to permit rhythm analysis.
Participants without any recording were assigned a value of 0 hours.
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7 days
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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。
调查人员
- 首席研究员：Michael Schreinlechner, MD、Medical University Innsbruck
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 (实际的)
2025年9月18日
初级完成 (实际的)
2026年5月1日
研究完成 (估计的)
2026年7月1日
研究注册日期
首次提交
2026年4月27日
首先提交符合 QC 标准的
2026年4月27日
首次发布 (实际的)
2026年5月4日
研究记录更新
最后更新发布 (实际的)
2026年6月25日
上次提交的符合 QC 标准的更新
2026年6月22日
最后验证
2026年4月1日
更多信息
与本研究相关的术语
其他研究编号
- 1133/2025
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
De-identified individual participant data underlying the published results will be made available to researchers whose proposed use has been approved by an independent review committee, for analyses that have received appropriate ethics approval.
Requesters will be asked to sign a data access agreement.
Data are held in controlled-access storage at the Medical University of Innsbruck.
IPD 共享时间框架
Beginning 6 months and ending 5 years after publication.
IPD 共享访问标准
Proposals should be directed to the corresponding author.
Access will be granted for approved analyses with appropriate ethics approval, after signing a data access agreement.
IPD 共享支持信息类型
- 研究方案
- 树液
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
不
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.