A pilot prospective study to evaluate Electrocardiogram (ECG) signal acquisition and functionality of newly developed External Cardiac Monitoring (ECM) prototype

India Medtronic Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年1月9日

试验速览

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•1) Above 18 years of age
•2) Patients with the previous history of cardiovascular disease
•3) Patients with a previous history of cardiovascular disease (or) suspected (or) increased risk of cardiac arrhythmia in the setting of unexplained syncope, cryptogenic stroke or with transient symptoms of dizziness, palpitations, or chest pain
•4) Enroll only In-patients who can complete for the Group A study
•5) The subject is willing to sign the Informed consent form

•1) Patients implanted with Cardiac Implantable Electronic Device (CIED) (e.g., IPG, ICD, CRT, etc.)
•2) Any high-risk patient who is already implanted or needs an implant with other life sustaining equipment during the course of study, that may interfere with the function of Cardilinq External Cardiac Monitor(ECM) prototype should be excluded as per physician discretion
•3) Patients with a history of sweat allergy
•4) Patients with prior evidence of skin irritation or symptoms of skin infection OR wound at any point where the ZephyrTM Bioharness chest strap will contact the subject
•5) Female patients who are pregnant and breastfeeding
•6) Not willing to consent

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