None listed
Conditions
Brief summary
This study will evaluate the usability and functionality of the MoMe continuous ECG monitoring and arrhythmia detection system. The device is intended for patients who have a demonstrated need for cardiac monitoring to detect arrhythmias (abnormal heart rhythms and rates) which could pose a danger to the patient’s health. The MoMe device records electrical signals from the heart through a series of electrodes attached to the chest, providing a range of information including the heart rhythm, heart rate, respiration rate, blood pressure and motion activity level. Standard of care ECG monitoring devices used only monitor heart activity for a short duration (24-48hrs) and because of this, transient arrhythmias can go undetected. The diagnosis by the doctor is also delayed as the device data has to be sent to a lab for review and analysis before he/she can receive it. The technology of this new MoMe device overcomes the issue of a missed or delayed diagnosis by facilitating heart monitoring for a longer period and by providing real time data to the physician for review at the current moment that the patient is wearing the device. The study will involve up to 40 patients at up to two New Zealand sites. Participants will be aged 18-85 and will have a previously diagnosed known arrhythmia for which no treatment or intervention is medically required during monitoring. Participants will have the device attached in the hospital by a trained technician and wear it for up to two weeks. The data will be continuously analysed for arrhythmias and transmitted to a cloud application where it can be viewed in real time. For the purposes of minimising bias in this research study, the investigator will be blinded to the patient’s data. The investigator will be informed by the Sponsor if any new arrhythmias are detected by the device. The patient will return to the hospital at the end of the monitoring period and have the device disconnected, at which point they will exit the study.
Interventions
Patients will wear a device (MoMe) for 14-30 days at the physician's discretion, which is a Continuous ECG Monitoring and Arrhythmia Detection System attached to the surface of the skin on the chest via electrodes. The device will be removed when the patient needs to shower. The patient will remove the device and reattach it themselves. The time periods that the patient wears the device will be monitored and recorded.
Sponsors
Infobionic
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1.Male or female subject between the ages of 18-85 years old. 2.Subject has known, diagnosed arrhythmia of any type included in the Indications for Use for which no additional treatment or intervention is medically required during the monitoring period. 3.Subject agrees to comply with all study requirements including initial set-up clinical visit, monitoring period and follow-up visits. 4.Subject has completed signed written informed consent.
Exclusion criteria
1.Female subject is pregnant or intends to become pregnant during the MoMe monitoring period. 2.Subject has an implanted ICD or pacemaker. 3.Subject has potentially life-threatening arrhythmias that require inpatient monitoring. 4.Subject the attending physician thinks should be hospitalized. 5.Subject that requires QT interval monitoring during the initiation of antiarrhythmic therapy; where in patient monitoring is required by the drug labeling. 6.Subject has undergone an interventional procedure or surgery within the past six (6) months. 7.Subject has any other medical condition that in the opinion of the investigator study participation would cause undue harm to the subject. 8.Subject is actively participating in any other investigational drug or device study.
Outcome results
None listed