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临床试验/CTRI/2025/02/081461
CTRI/2025/02/081461已完成不适用

Comparison of Holter Monitors and Wireless Patch Devices in Cardiac patients: Validation of Wireless Patch Device

Sunfox Technologies Private Limited1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年3月5日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Compare the ability of wireless patch devices and Holter monitors to accurately detect and diagnose cardiac arrhythmias and other ECG abnormalities.

研究概览

简要总结

This single-center, comparative, observational study at AIIMS Rishikesh aims to evaluate the diagnostic accuracy and overall reliability of a wireless patch device compared to a traditional Holter monitor for continuous cardiac monitoring. Fifty adult patients (above 20 years) with a history of cardiac symptoms and indications for ambulatory ECG monitoring will be enrolled. Following informed consent, participants will simultaneously wear both devices for a 24-hour period. Data from each device will be collected, analyzed, and compared in terms of arrhythmia detection rates, signal quality, patient comfort, and technical feasibility. The study will also incorporate patient feedback on ease of use and adherence. Statistical analysis will include constructing a confusion matrix and calculating sensitivity, specificity, positive predictive value, and negative predictive value. By comparing accuracy, usability, and compliance between the two devices, the research seeks to validate the wireless patch as a reliable alternative to the Holter monitor for extended cardiac monitoring in clinical practice.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 95.00 Year(s)(—)
性别
All

入选标准

  • Patients with a history of cardiac symptomssuch as chest pain, lightheadedness, or breathlessness and those recommended for ambulatory ECG monitoring.

排除标准

  • Patients with significant skin conditions where device adhesion may be problematic.
  • Patients unable to comply with study protocols.

结局指标

主要结局

Compare the ability of wireless patch devices and Holter monitors to accurately detect and diagnose cardiac arrhythmias and other ECG abnormalities.

时间窗: 1 year

次要结局

  • Analyse the correlation between ECG data from wireless patch devices and Holter monitors.(1 year)

研究者

发起方
Sunfox Technologies Private Limited
申办方类型
Other [Medical Device manufacturer]
责任方
Principal Investigator
主要研究者

Dr Bhanu Duggal

All India Institute of Medical Sciences

研究点 (1)

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