Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5.1-2018-18343 | Registry Identifier | Swedish Medical Products Agency | |
| 2018/9 | Registry Identifier | Regional Ethical Review Board in Lund, Sweden |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECG monitoring system CardioSenseSystem group | Experimental |
| |
| ECG monitoring system Philips Intellivue | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CardioSenseSystem | Device | CardioSensySystem is a novel wireless ECG monitoring system developed by Novosense AB for monitoring of ECG in health care departments. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lost of monitoring data | Compare time of interruptions in the monitoring system between the investigational device and the control device. | During 24 hour per subject |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During 24 hour per subject |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonas Tilly | Contact | +46709905725 | jonas.tilly@novosense.se |
| Name | Affiliation | Role |
|---|---|---|
| Rikard Linnér, MD PhD EDIC | Skane University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VO Thorax o Kärl, Region SkĂ¥ne | Lund | EntrĂ©gatan 7 | SE-222 41 | Sweden |
Not provided
| Label | URL |
|---|---|
| Sponsors website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000789 | Angina, Unstable |
| D006349 | Heart Valve Diseases |
| D001018 | Aortic Diseases |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
The study participants will be using both the experimental device and the control device simultaneously throughout the study participation. The participant will thereby act as its own control.
Not provided
Not provided
Not provided
Not provided
| Philips Intellivue | Device | Philips Intellivue in an established ECG monitoring system used at the clinical investigational device. |
|
| Number of correct yellow and red alarm |
Compare the number of correct yellow and red alarm between the investigational device and the control device. |
| 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. | 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. | During 24 hour per subject |
| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |