Prospective Observational Comparative Pilot Study to Evaluate Performance of an AI-based Cardiac Disease Analysis Algorithm Using Standard 12-lead ECG and Single-lead ECG Data

DeepCardio0 个研究点目标入组 300 人开始时间: 2026年8月3日最近更新: 2026年7月13日

适应症

试验速览

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研究类型: Observational
观察模型: Others, Time Perspective : Prospective, Enrollment : 300, Biospecimen Retention : Not collect nor Archive

•Subjects who voluntarily agreed in writing to participate in this clinical study
•adults over 19 years of age
•Patients subjected to standard 12-lead ECG measurements during the study period
•Those whose ECG at the time of inspection is sinus rhythm
•Those who can measure 1-lead ECG additionally during the same visit

•A person who is difficult or inappropriate to conduct research as judged by the research manager
•Patients with an atrial fibrillation or atrial flutter at the time of examination
•Pacemaker-induced pacing rhythm patient
•Those who have difficulty measuring 1-lead ECG due to severe Tremor, inability to cooperate, and skin conditions
•A person who is likely to delay standard medical treatment due to a serious medical situation
•A person who wishes to withdraw his/her consent or who does not consent to the use of personal information
•ECG below quality standards (non-analytic level noise, lead disconnection, etc.)
•However, the analysis impossibility evaluation can be recorded separately

发起方

DeepCardio