Hativ® 心电图监测疑似心律失常患者 (HELP-A)
2026年9月1日 更新者：Young Jun Park、Wonju Severance Christian Hospital
HELP-A 研究是一项单中心、随机、对照试验。
在2年的入组期和1个月的随访期内共有588名患者入组。
本研究旨在比较连续心电图贴片和间歇性手持式心电图对心律失常症状患者的诊断率。
研究概览
详细说明
HELP-A 研究是一项单中心、随机、对照试验，旨在比较连续心电图贴片和间歇性手持式心电图对心律失常症状患者的诊断率、心律失常检出率、用户便利性和成本效益。
有心律失常症状但 12 导联心电图未确诊且需要额外检查的患者。
在2年的入组期和3个月的随访期内共有588名患者入组。
患者将被分配接受连续贴片心电图或间歇性手持式心电图检查，并接受为期一个月的检查。
如果一个月后仍未得到诊断，患者将被转移到另一台设备并再检查一个月。
研究类型
介入性
注册 (估计的)
588
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。
学习联系方式
- 姓名：Young Park, MD
- 电话号码：82-2-920-5445
- 邮箱：yjparkcardio@gmail.com
学习地点
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Dong-gu Jaebongro 42
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Gwangju、Dong-gu Jaebongro 42、韩国、61469
- 招聘中
- Chonnam National University Hospital
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接触：
- Ki hong Lee, MD
- 电话号码：82 01-9962-5830
- 邮箱：drgood2@naver.com
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Gangwon-do
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Wŏnju、Gangwon-do、韩国、26426
- 招聘中
- Wonju Severance Christian Hospital
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接触：
- Min-Soo Ahn
- 邮箱：heartsaver@yonsei.ac.kr
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Hwaseong-si Keunjaebong-gil 7
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Gyeonggi-do、Hwaseong-si Keunjaebong-gil 7、韩国、18450
- 招聘中
- Hallym University Dongtan Sacred Heart Hospital
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接触：
- Seong Woo Han Professor, MD
- 电话号码：82 01-2630-6489
- 邮箱：hansw29@hallym.or.kr
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Seongbuk-gu, 73 Goryeodae-ro
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Seoul、Seongbuk-gu, 73 Goryeodae-ro、韩国、02841
- 招聘中
- Korea University Anam Hospital
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接触：
- Young Jun Park
- 电话号码：82-2-920-5445
- 邮箱：yjparkcardio@gmail.com
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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
描述
纳入标准：
- 有心律失常症状但 12 导联心电图未确诊且需要额外检查的患者。
- 可以使用智能手机的患者
排除标准：
- 拥有心脏植入式电子设备 (CIED) 的患者
- 无法使用手持式心电图仪的患者
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 |
|---|---|
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实验性的：Memo Patch continuous ECG strategy
Participants undergo continuous single-lead ECG monitoring with Memo Patch for up to 7 consecutive days and report symptom onset using a mobile messaging chatbot or paper diary.
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Continuous single-lead ECG monitoring for up to 7 consecutive days.
Participants report the onset of symptoms using a mobile messaging chatbot or paper diary.
For each reported symptomatic episode, a 20-minute ECG segment extending from 10 minutes before to 10 minutes after the reported onset is available for review.
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有源比较器：Hativ handheld ECG strategy
Participants use Hativ for 30 days and perform 10-second 6-lead ECG recordings at least twice daily and whenever symptoms occur.
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Handheld ECG monitoring using 10-second 6-lead recordings obtained at least twice daily and additionally whenever symptoms occur for 30 days.
Recordings are transmitted through the companion smartphone application to a secure study server.
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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 |
|---|---|---|
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Clinically informative symptom-rhythm correlation with the initially assigned device by 1 month
大体时间：From randomization through the 1-month follow-up visit
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Proportion of randomized participants with at least one participant-confirmed typical symptomatic episode documented with an interpretable ECG using the initially assigned device by the 1-month follow-up visit and before optional sequential monitoring.
Primary-endpoint success comprises either a positive symptom-rhythm correlation or a negative-only symptom-rhythm correlation.
A positive correlation is a qualifying symptomatic episode with an interpretable ECG showing a rhythm finding judged by central adjudication to be temporally and clinically concordant with that episode.
A negative-only correlation requires at least one qualifying symptomatic episode with an interpretable ECG showing no concordant rhythm finding and no positive correlation by the 1-month visit.
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From randomization through the 1-month follow-up visit
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Positive symptom-rhythm correlation
大体时间：By the 1-month follow-up visit
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Proportion of participants with at least one qualifying participant-confirmed typical symptomatic episode documented with an interpretable ECG showing a rhythm finding judged by central adjudication to be temporally and clinically concordant with that episode.
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By the 1-month follow-up visit
|
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Negative-only symptom-rhythm correlation
大体时间：By the 1-month follow-up visit
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Proportion of participants with at least one qualifying participant-confirmed typical symptomatic episode documented with an interpretable ECG showing no temporally and clinically concordant rhythm finding and with no positive correlation by the 1-month follow-up visit.
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By the 1-month follow-up visit
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Both positive and negative episodes
大体时间：By the 1-month follow-up visit
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Proportion of participants with at least one qualifying positive symptom-rhythm correlation and at least one qualifying negative symptom-rhythm correlation.
This measure is descriptive.
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By the 1-month follow-up visit
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Clinically significant arrhythmia detected during assigned-device monitoring
大体时间：By the 1-month follow-up visit
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Proportion of participants with at least one centrally adjudicated clinically significant arrhythmia detected during initially assigned-device monitoring, irrespective of symptom association.
Clinically significant arrhythmias are classified using prespecified device-specific operational definitions.
Findings are additionally classified as symptom-associated or not temporally associated with a qualifying typical symptomatic episode.
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By the 1-month follow-up visit
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Arrhythmia-directed therapeutic intervention
大体时间：Through 3 months after randomization
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Rate and timing of arrhythmia-directed therapeutic interventions, including medication, catheter ablation, or cardiac device implantation.
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Through 3 months after randomization
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Overall satisfaction
大体时间：1-month follow-up visit
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Overall device satisfaction measured using the prespecified ordinal response scale in the 1-month participant questionnaire.
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1-month follow-up visit
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EQ-5D-5L
大体时间：Baseline to 1 month
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Change in the EQ-5D-5L index score from enrollment to the 1-month follow-up visit.
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Baseline to 1 month
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Healthcare resource utilization and costs
大体时间：Through 3 months after randomization
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Arrhythmia-related healthcare resource use through 3 months, including additional diagnostic tests, arrhythmia-related medications, emergency department visits, and hospitalizations.
Costs are derived from institutional billing records at participating centers and expressed in Korean won.
The base-case analysis excludes acquisition cost of the study devices because the devices were supplied in kind.
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Through 3 months after randomization
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Safety Outcome
大体时间：Through 3 months after randomization
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Number and proportion of participants experiencing device-related or serious adverse events.
Expected device-related events include skin irritation or contact dermatitis associated with the adhesive patch and discomfort associated with device use.
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Through 3 months after randomization
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Sequential-monitoring participant questionnaire
大体时间：3-month follow-up
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Among participants who undergo optional sequential monitoring with both study devices, paired ratings of device usability, overall satisfaction, preference, willingness to recommend, and willingness to use each device again are collected using the 3-month head-to-head questionnaire.
This analysis is exploratory because eligibility for sequential monitoring depends on the outcome of the initially assigned strategy
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3-month follow-up
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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：Young Jun Park, MD、Wonju Severance Christian Hopsital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Schreiber D, Sattar A, Drigalla D, Higgins S. Ambulatory cardiac monitoring for discharged emergency department patients with possible cardiac arrhythmias. West J Emerg Med. 2014 Mar;15(2):194-8. doi: 10.5811/westjem.2013.11.18973.
- Raviele A, Giada F, Bergfeldt L, Blanc JJ, Blomstrom-Lundqvist C, Mont L, Morgan JM, Raatikainen MJ, Steinbeck G, Viskin S, Kirchhof P, Braunschweig F, Borggrefe M, Hocini M, Della Bella P, Shah DC; European Heart Rhythm Association. Management of patients with palpitations: a position paper from the European Heart Rhythm Association. Europace. 2011 Jul;13(7):920-34. doi: 10.1093/europace/eur130. No abstract available.
- Turnbull S, Garikapati K, Bennett RG, Campbell TG, Kotake Y, Mahajan R, Marschner S, Byth K, Chow CK, Kumar S. Utility of a Handheld, Single-Lead ECG Device for Diagnosis of Cardiac Arrhythmias. J Am Coll Cardiol. 2023 Jun 13;81(23):2292-2294. doi: 10.1016/j.jacc.2023.03.428. No abstract available.
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)
2024年2月22日
初级完成 (估计的)
2026年12月31日
研究完成 (估计的)
2026年12月31日
研究注册日期
首次提交
2024年1月31日
首先提交符合 QC 标准的
2024年2月7日
首次发布 (实际的)
2024年2月9日
研究记录更新
最后更新发布 (实际的)
2026年9月4日
上次提交的符合 QC 标准的更新
2026年9月1日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他研究编号
- CR223024
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 primary publication, together with a data dictionary, will be available from the corresponding investigator on reasonable request after completion of the study and publication of the primary results, subject to ethics approval and execution of an appropriate data-use agreement.
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
在美国制造并从美国出口的产品
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.