None listed
Conditions
Brief summary
Arrhythmia is a condition where there is a change to the normal sequence of electrical activation of the heart. Some arrhythmias are associated with an increased risk of stroke and heart failure. A Holter monitor is a battery operated portable device that records electrical heart activity continuously often for 24 to 48 hours to assist with the diagnosis and assess the management of arrhythmia. Due to factors that includes the cost of Holter monitoring devices and maintenance, Counties Manukau Health (CM Health) has a limited number available for testing, resulting in a waiting list of over 200 patients. Samsung has developed a Bio-Processor, a single, compact chip that is capable of measuring PPG, ECG, skin temperature, GSR and body fat. This Bio-Processor is built in a device called the “S-Patch”, attachable to the chest with two electrode stickers, similar to a Holter monitor that attaches to the chest via three electrode stickers. This device can collect, store and process the data on the device. The data can also be transmitted in real time to a mobile phone via blue tooth, and will later be transmitted to a cloud for analysis and reporting, with data accessible at desk tops, tablets or other mobile devices. This 2 part study has been designed to establish Proof of Concept of the S-patch device for both the data generated and the participant/clinical team experience, when compared to Holter monitoring.
Interventions
A Holter monitor is a battery-operated portable device that records electrical heart activity continuously, often for 24 to 48 hours, to assist with the diagnosis, assessment and management of arrhythmias. Samsung has developed a Bio-Processor, a single, compact chip that is capable of measuring PPG, ECG skin temperature, GSR and body fat. This Bio-Processor is built into a device called the “S-Patch”, attachable to the chest with two electrode stickers; similar to a Holter monitor that attache
A Holter monitor is a battery-operated portable device that records electrical heart activity continuously, often for 24 to 48 hours, to assist with the diagnosis, assessment and management of arrhythmias. Samsung has developed a Bio-Processor, a single, compact chip that is capable of measuring PPG, ECG skin temperature, GSR and body fat. This Bio-Processor is built into a device called the “S-Patch”, attachable to the chest with two electrode stickers; similar to a Holter monitor that attaches to the chest via five electrode stickers. A low-risk, open-label, interventional study to compare data collected simultaneously from an S-Patch and Holter ambulatory ECG device in a community setting. Patients will be fitted with both the S-Patch and a Holter monitor for 24 hours, filling out a questionnaire to compare the experience of using both devices. The data collected is immediately loaded into the cloud to confirm evaluability and will be later analysed by the clinical team to establish accuracy and efficacy. Any relevant clinical findings will be reported to the patient's medical team, using the holter data only. The clinical team will also complete a questionnaire comparing the experience of using both devices. A report will be generated with recommendations made for any changes required to the software and/or hardware. The trial has been staged in 3 parts: Part 1: Pilot Simultaneous S-Patch and Holter Monitor Comparison (beta testing phase), looking at 25 patients where the S-patch analysis software is updated during the evalaution. Part 1a: Pilot Simultaneous S-Patch and Holter Monitor Comparison (confirmation of beta -testing completion phase), looking at 5 patients after further refinement of the S-patch device. Part 2: Simultaneous S-Patch and Holter Monitor Comparison (proof of concept), looking at 60 patients using a static "final" S-patch device and analytical software,
Sponsors
Counties Manukau Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria: - Aged >= 18 years - Able to speak and understand English - Able to complete all study instructions and questionnaires - Able to provide informed consent - Able to operate a smart mobile phone - Cardiologist referral for Holter Monitoring - Online access to referral letter, meds, demographic information and rationale for Holter evaluation
Exclusion criteria
Exclusion Criteria: - Pacemaker patients that are Pacemaker dependent - Implantable Cardiac Defibrillator (ICD) patients
Outcome results
None listed