An interventional study of CardioSenseSystem and Philips Intellivue in Cardiac Arrythmias, Unstable Angina and Heart Valve Disorders, sponsored by Novosense AB. Status unknown at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-11.
Sponsored by Novosense AB · Not applicable, Interventional, and Prevention
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.
A prospective, controlled and comparative clinical trial before CE marking of a new ECG monitoring system CardioSenseSystem. 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 monitored by both the investigational device and the control device for measuring data loss, management time and alarm function up to 24 hours. The duration of the study is estimated to 4 months.
CardioSenseSystem is designed to provide wireless high-quality ECG monitoring. The system developed by Novosense AB consists of three components: the CardioPatch, the Novosense Base Station and the Back-End System. The CardioPatch is a wireless sensor capable to record and transmit ECG data. The CardioPatch send ECG data to the Novosense Base Station, which is the receiving unit. The Back-End System is used for presentation, storage and processing of ECG information. The CardioPatch sensor is applied to the body with an adhesive in the same way as a traditional ECG electrode. In contrast, the CardioPatch is a fully integrated unit containing electrodes, ECG amplifier and a radio transmitter. Novosense's wireless ECG sensors, CardioPatch, transmits the ECG signal 24 hours to the Novosense Base Station receiver.
885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.
This study's planned enrollment of 60 is below the median of 99 across 429 interventional studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →This is the only study on the registry with Novosense AB as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: CardioSenseSystem
Device: Philips Intellivue
CardioSensySystem is a novel wireless ECG monitoring system developed by Novosense AB for monitoring of ECG in health care departments.
Philips Intellivue in an established ECG monitoring system used at the clinical investigational device.
Lost of monitoring data
Compare time of interruptions in the monitoring system between the investigational device and the control device.
Time frame: During 24 hour per subject
Management time
Compare management time between the investigational device and the control device. This is done by measuring the time required for the sterilization of cables, battery replacements, application of electrodes and cables, and extra management time for applying electrodes and cables if unconnected.
Time frame: During 24 hour per subject
Number of correct yellow and red alarm
Compare the number of correct yellow and red alarm between the investigational device and the control device.
Time frame: During 24 hour per subject
Number of false yellow and red alarm
Compare the number of false yellow and red alarm for the investigational device and the control device.
Time frame: During 24 hour per subject
Incidence and severity of Averse Events
The incidence and severity of adverse events associated with the investigational device and the control device.
Time frame: During 24 hour per subject
Plan to share: Undecided
This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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