- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03610529
CardioSenseSystem Compared Study Regarding Efficacy and Safety in the Monitoring of ECG
CardioSenseSystem Compared to Philips Telemetry System Regarding Efficacy and Safety in the Monitoring of ECG
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jonas Tilly
- Phone Number: +46709905725
- Email: jonas.tilly@novosense.se
Study Locations
-
-
Entrégatan 7
-
Lund, Entrégatan 7, Sweden, SE-222 41
- VO Thorax o Kärl, Region Skåne
-
Contact:
- Rikard Linnér, MD PhD EDIC
- Phone Number: +4646177376
- Email: rikard.linner@skane.se
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
- Patient with mechanical auxiliary heart or ECMO.
- Patient with implantable defibrillator.
- Severely ill patient during end of life.
- Patient participating in any other clinical trial.
- Patient where the investigator judge that participation may be risky for the patient or obstruct or interfere the implementation of the trial as approved.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ECG monitoring system CardioSenseSystem group
|
CardioSensySystem is a novel wireless ECG monitoring system developed by Novosense AB for monitoring of ECG in health care departments.
|
Active Comparator: ECG monitoring system Philips Intellivue
|
Philips Intellivue in an established ECG monitoring system used at the clinical investigational device.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lost of monitoring data
Time Frame: During 24 hour per subject
|
Compare time of interruptions in the monitoring system between the investigational device and the control device.
|
During 24 hour per subject
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Management time
Time Frame: During 24 hour per subject
|
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
|
Number of correct yellow and red alarm
Time Frame: During 24 hour per subject
|
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
Time Frame: During 24 hour per subject
|
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
Time Frame: During 24 hour per subject
|
The incidence and severity of adverse events associated with the investigational device and the control device.
|
During 24 hour per subject
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rikard Linnér, MD PhD EDIC, Skåne University Hospital
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NovoECG
- 2018/9 (Registry Identifier: Regional Ethical Review Board in Lund, Sweden)
- 5.1-2018-18343 (Registry Identifier: Swedish Medical Products Agency)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Unstable Angina
-
Korea University Anam HospitalCompletedDiabetic Stable Angina | Diabetic Unstable AnginaKorea, Republic of
-
Gennaro SardellaUnknownNon ST Segment Elevation MI and Unstable AnginaItaly
-
Bon-Kwon KooSamsung Medical Center; Chonnam National University Hospital; Seoul National... and other collaboratorsCompleted
-
Ulsan University HospitalSeoul National University HospitalCompletedStable Angina | Unstable AnginaKorea, Republic of
-
University Hospital TuebingenAcrostakUnknownMyocardial Ischemia | Stable or Unstable Angina PectorisGermany
-
CID - Carbostent & Implantable DevicesCompletedStable Angina | Unstable Angina | NSTEMINetherlands, Italy
-
Medhub Ltd.CompletedStable Angina | Unstable Angina | NSTEMIIsrael
-
Ospedale San DonatoTerminatedStable Angina | Unstable AnginaItaly
-
Jun LiUnknown
-
Jun LiGuang'anmen Hospital of China Academy of Chinese Medical SciencesUnknown