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临床试验/CTRI/2026/04/108963
CTRI/2026/04/108963尚未招募不适用

CARDIO SENSE Wearable ECG Monitor for Early Detection of Cardiac Arrhythmias .

Saveetha Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年4月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1

研究概览

简要总结

The CARDIO SENSE study aims to evaluate the effectiveness of a wearable ECG monitoring systemdesigned to continuously record cardiac electrical activity and early detect cardiac arrhythmias in adult participants. This non-invasive wearable device continuously collects high-fidelity ECG signals and related vital data to identify clinically significant arrhythmias such as atrial fibrillation, bradycardia, tachycardia, and other rhythm disturbances. The system integrates real-time data acquisition with automated analysis to alert clinicians and participants promptly upon detection of arrhythmic events. The study will assess the diagnostic accuracy of the wearable monitor compared with standard clinical ECG/Holter monitoring, and determine its feasibility for long-term ambulatory cardiac surveillance to support early intervention and improved clinical outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Population with suspected or confirmed intermittent arrhythmias e.g., palpitations, syncope, post-stroke AF screening.

排除标准

  • Dermatologic conditions precluding electrode placement.Implanted devices causing uninterpretable noise (if not filtered).Hemodynamic instability requiring continuous bedside monitoring only.

研究者

发起方
Saveetha Medical College and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Gulipalli Pallavi

Saveetha Medical College & Hospital

研究点 (1)

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