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Clinical Application of a New Handheld ECG Device (CANHED)

2026年6月19日 更新者：HeartEye

To investigate possible heart disease, an electrocardiogram (ECG) is needed. For this, a person usually must go to the hospital, sometimes urgently. There, an ECG is performed using a device with 10 wires attached to the skin with adhesive pads or suction cups. Taken together, a time-consuming procedure.

With a simple and pocket-size ECG device, it is being investigated whether this procedure can be made faster and easier, thereby improving the availability and accessibility of a heart tracing.

With a simple and pocket-size ECG device, it is being investigated whether this procedure can be made faster and easier, thereby improving the availability and accessibility of a heart tracing.

By holding this new device against the chest, a heart recording is made and stored via a smartphone so that it can be remotely reviewed by a doctor.

The goal of this study is to establish that the new method of ECG registration is at least as good as the conventional way.

The number of successfully completed (suitable for interpretation) ECGs will be compared to the total number of ECG registrations; also, the number of adverse events will be scored as well as user satisfaction.

There are no risks associated with participating in this study. The burden is minimal: an extra ECG within 1 minute without using any adhesives or wires.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Cardiovascular diseases (CVD) affect around 620Mn people, 1 in 13 of the world's population. The number of people affected is increasing due to changing lifestyles and a growing and aging population. CVDs are a leading cause of mortality and morbidity worldwide. They place a significant burden on healthcare systems, government budgets, and the lives of patients and caregivers. In 2019, CVDs accounted for 17.9Mn deaths worldwide - 32% of all deaths.

Specifically, heart attacks and strokes were responsible for 85% of these deaths, with a third occurring prematurely in individuals under 70 years4. The total annual costs of CVDs, including healthcare costs, productivity losses, and informal care, are estimated to be around €210Bn in Europe and €380Bn in the US.

Over the past decades, significant progress in CVD diagnostics has resulted in a wide range of diagnostic tools. However, the gold-standard 12-lead ECG remains indispensable for accurately detecting complex and life-threatening cardiac conditions like myocardial infarction (MI). While simpler devices provide convenience, they lack the precision needed for diagnosing such critical pathologies.

HeartEye is a Dutch pioneering medical technology company that has developed and aims to receive regulatory approvals of a handheld ECG device to provide accessible, accurate, and user-friendly electrocardiogram (ECG) diagnostics through innovative technology, and portable, medical-grade devices that empower individuals and healthcare professionals (HCPs) with timely and precise cardiac health insights.

To test the employment, feasibility, clinical performance, and safety of HeartEye's ECG device, 594 patients admitted to the hospital will be enrolled for (near) simultaneous registration of a standard ECG and a HeartEye ECG for comparison of diagnosis by an independent expert panel of cardiologists to assess the degree of agreement. A HeartEye ECG can be performed within 60 seconds by simply holding the device against the chest without the use of adhesives, thereby causing minimal burden or risks for patients, if any.

研究类型

观察性的

注册 (估计的)

594

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：Rien van der Zee, MD, PhD
  • 电话号码：+31 6 55756354
  • 邮箱：rien@hearteye.nl

研究联系人备份

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

概率样本

研究人群

Patients visiting a hospital with a known cardiac condition or complaints suspected of cardiac disease.

描述

Inclusion Criteria:

To be eligible for enrolment in this study after adequately being informed, a participant must meet all the following criteria:

Adult (>18years old) patients admitted to the Meander Medical Centre Amersfoort (NL) or the Catharina Hospital Eindhoven (NL) visiting the outpatient clinic with a known cardiac condition or complaints suspected of cardiac disease.

Exclusion Criteria:

A potential participant who meets any of the following criteria will be excluded from participation in this study:

  • Not intact skin condition in the sternal area (e.g. recent thoracic surgery, skin eruptions, caustic trauma, etc.)
  • Unable to understand the procedure (e.g. comatose, incapacitated, or critically ill patients).

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
Patients visiting a hospital that are scheduled for an ECG registration receive 1 additional ECG

Patients diagnosed with various conditions will be selected to create a diverse mixture of cardiac pathology in the following categories:

  1. Normal, atypical cardiac complaints, extrasystole
  2. Ischemic diseases
  3. Arrhythmia, conduction delay
  4. Cardiomyopathy
  5. Pacemaker therapy
  6. Systemic diseases (e.g., hypothyroidism, electrolyte disorder) Intervention: 1 additional ECG with a handheld ECG device.
设备：ECG registration with a handheld ECG device.
Patients admitted to the hospital that are subjected to routine ECG registration can be enrolled in the study by adding a HeartEye ECG nearly simultaneously, meaning within 5 minutes before or after the routine ECG registration. Another 60 seconds per ECG added to the procedure due to enrolment in this study, causing a minimal burden for the patient.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Primary Objective: To test non-inferiority, diagnostic agreement of the 12 lead HeartEye ECG will be determined by comparing individual cardiologist diagnosis per category to the traditional ECG.
大体时间：4 months after first inclusion.
4 months after first inclusion.

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

HeartEye

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

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6月22日

初级完成 (估计的)

2026年7月22日

研究完成 (估计的)

2026年10月22日

研究注册日期

首次提交

2026年6月8日

首先提交符合 QC 标准的

2026年6月19日

首次发布 (实际的)

2026年6月25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19日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • NL011365

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

ECG data. Patients characteristics. Questionnaires.

IPD 共享时间框架

Start date availability: Nov 30, 2026 for 15 years.

IPD 共享访问标准

Reviewers can access ECG data, patients characteristics, and questionnaires via the platform of the company's website. The key to a patient ID is stored separately in the participating hospitals.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 分析代码
  • 企业社会责任

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

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.

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