跳至主要内容
临床试验/NCT06870175
NCT06870175招募中不适用

Non-Invasive Ambulatory Monitoring of Electrocardiogram (ECG) and Arrhythmia Detection Using Textile Electrodes

Myant Medical Corp.2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年2月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
2
主要终点
Arrhythmia Detection

研究概览

简要总结

This research is a clinical evaluation of the Skiin chest band, a smart garment with embedded electronic textile (e-textile) electrodes, to record body surface electrocardiogram (ECG) signals. Developed by Myant Textile Computing Inc., the Skiin chest band (i.e. as part of the Skiin Underwear family of garments) is a component of the Myant Health Platform (MHP). The MHP also consists of: (a) a mobile phone application (Skiin Connected Life Application; SCLA), and (b) the Myant Virtual Clinic Portal (MVCP). In this study, participants will wear the Skiin chest band to collect their ECG for a period of 14 days. Participants will also be provided with a smartphone that is pre-loaded with the SCLA to record any symptoms (e.g. palpitations, shortness of breath, fatigue, light- headedness, fainting, etc.) they may experience over the 14 day ECG monitoring period. The data collected in this study will be used to develop new algorithms and patient monitoring tools to detect and predict cardiovascular health problems.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being referred to the Partners in Advanced Cardiac Evaluation (PACE Cardiology), and having been prescribed a 14-day ambulatory ECG monitoring by their physician.
  • Able to understand and speak English language, enough to provide informed consent.

排除标准

  • Age < 18 years
  • Pregnancy
  • Cardiovascular Implantable Electronic Devices (CIED), including Implanted cardioverter defibrillator (ICD) or pacemakers
  • Absence of chest band that fits the participant's body
  • Open wound or dressing on a body part that needs to be in contact with the Skiin garment

结局指标

主要结局

Arrhythmia Detection

时间窗: Each participant undergoes up to 14 day ambulatory ECG monitoring from the time of wearing the Skiin chest band.

To evaluate the performance of Skiin chest band in collecting ambulatory body surface ECG, and in detecting the presence or absence of arrhythmias for up to 14 days

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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