Cardiac ArrythmiasNCT03610529
CardioSenseSystem Compared Study Regarding Efficacy and Safety in the Monitoring of ECG
A study testing CardioSenseSystem and Philips Intellivue in people with Cardiac Arrythmias and Unstable Angina, run by Novosense AB at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrythmias, Unstable Angina, Heart Valve Disorders
- What is being tested?
- CardioSenseSystem and Philips Intellivue
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2020to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
VO Thorax o Kärl, Region Skåne
Lund, Entrégatan 7, SE-222 41
Rikard Linnér, MD PhD EDIC, +4646177376, rikard.linner@skane.se
About this study
Official title: CardioSenseSystem Compared to Philips Telemetry System Regarding Efficacy and Safety in the Monitoring of ECG
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.
Read the 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.
- Being tested
- CardioSenseSystem, Philips Intellivue
- Keywords
- ECG Monitoring, Controlled, Comparative, Clinical trial
- Medical subject headings
- Angina, Unstable, Heart Valve Diseases, Aortic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioSenseSystemDevice
CardioSensySystem is a novel wireless ECG monitoring system developed by Novosense AB for monitoring of ECG in health care departments.
Philips IntellivueDevice
Philips Intellivue in an established ECG monitoring system used at the clinical investigational device.
| Study group | Role | What they receive |
|---|---|---|
| ECG monitoring system CardioSenseSystem group | Experimental | Not described Receives: Device: CardioSenseSystem |
| ECG monitoring system Philips Intellivue | Active comparator | Not described Receives: Device: Philips Intellivue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lost of monitoring data
Compare time of interruptions in the monitoring system between the investigational device and the control device.
Measured: During 24 hour per subject
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During 24 hour per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study startSep 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrythmiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novosense AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rikard Linnér, MD PhD EDIC, Principal investigator, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610529
- Sponsor's protocol ID
- NovoECG
- Other IDs
- 5.1-2018-18343, 2018/9
- Status last verified
- Sep 2020
- First submitted
- 23 Jul 2018
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CardioSenseSystem Compared to Philips Telemetry System Regarding Efficacy and Safety in the Monitoring of ECG
- ClinicalTrials.gov ID
- NCT03610529
- Acronym / sponsor ID
- NovoECG
- Keywords
- ECG Monitoring, Controlled, Comparative, Clinical trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Novosense ABIndustry (pharma, biotech, devices)
- Study start
- Sep 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 1 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ECG monitoring system CardioSenseSystem group | Experimental | Device: CardioSenseSystem |
| ECG monitoring system Philips Intellivue | Active comparator | Device: Philips Intellivue |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CardioSenseSystemCardioSensySystem is a novel wireless ECG monitoring system developed by Novosense AB for monitoring of ECG in health care departments. | Device | ECG monitoring system CardioSenseSystem group |
| Philips IntellivuePhilips Intellivue in an established ECG monitoring system used at the clinical investigational device. | Device | ECG monitoring system Philips Intellivue |
Primary outcome
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.
4 secondary outcomes
Management time
Time frame: During 24 hour per subject
Number of correct yellow and red alarm
Time frame: During 24 hour per subject
Number of false yellow and red alarm
Time frame: During 24 hour per subject
Incidence and severity of Averse Events
Time frame: During 24 hour per subject
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- Sponsors websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rikard Linnér, MD PhD EDIC principal investigator
Skane University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CardioSenseSystem and Philips Intellivue in people with Cardiac Arrythmias and Unstable Angina, run by Novosense AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonas Tilly (+46709905725, jonas.tilly@novosense.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lost of monitoring data (time frame: During 24 hour per subject). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2020.