CardioSenseSystem Compared Study Regarding Efficacy and Safety in the Monitoring of ECG (NCT03610529) | Clinical Trial Compass
UnknownNot Applicable
CardioSenseSystem Compared Study Regarding Efficacy and Safety in the Monitoring of ECG
Sweden60 participantsStarted 2020-09
Plain-language summary
This is a prospective, controlled, comparative clinical trial of a new ECG monitoring system CardioSenseSystem prior CE marking. The aim of the study is to demonstrate that the CardioSenseSystem's cable-free ECG monitoring system (investigational device) is equivalent or better than traditional and accepted industry standard for cable-based ECG monitoring system (control device). In this study accepted industry standard is Philips Intellivue. In order to investigate this, the study will measure ECG monitoring interruptions, management time and alarm performance. The study population will consist of sixty (60) adult subjects requiring ECG and that are fulfilling the eligibility criteria for study participation. The subjects will be using both the investigational device and the control device simultaneous for measuring data loss, management time and alarm function up to 24 hours.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female at least 18 years old.
✓. Patient hospitalized at the investigational site and in need of ECG monitoring.
✓. Patient with expected alarms during the 24 hours ECG monitoring.
✓. Patient who has been informed of the clinical trials purpose, limitations and relevance, and who has voluntarily agreed to participation in the clinical trial by signing the informed consent form.
Exclusion criteria
✕. Patient with burns.
✕. Patient with known allergy or sensitivity to any of the compositions in CardioPatch.
✕. Patient with infection in the area where the electrodes are to be placed.
✕. Patient with fragile skin (eg after prolonged cortisone treatment).
✕. Patient with open sternum / sternum (eg severe heart failure postoperatively) or treatment for infection of the sternum.