Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000215224
Ethics application status
Approved
Date submitted
6/12/2017
Date registered
9/02/2018
Date last updated
9/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A low risk, open label, interventional Proof of Concept study to compare data collected simultaneously from S-patch and Holter ambulatory ECG devices fitted to patients with heart arrhythmia.
Scientific title
A low risk, open label, interventional Proof of Concept study to compare data collected simultaneously from S-patch and Holter ambulatory ECG devices.
Secondary ID [1] 293528 0
NA
Universal Trial Number (UTN)
U1111-1189-4459
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Arrhythmia 305718 0
Condition category
Condition code
Cardiovascular 304934 304934 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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,
Intervention code [1] 299763 0
Diagnosis / Prognosis
Comparator / control treatment
Holter monitor
Control group
Active

Outcomes
Primary outcome [1] 304126 0
Quality of data generated by both devices - analysis performed by cardiologists.
Raw data from the S-Patch device will be directly compared to raw data from the traditional Holter monitor, over 24 hours for ambulatory ECG readings.

A Cardiac Physiologist will assess
• Cardiac rhythm (sinus rhythm, atrial fibrillation, atrial flutter, junctional rhythm)
• Minimum, maximum and average heart rate
• Burden of atrial fibrillation and atrial flutter, junctional rhythm
• Premature Ventricular Contraction (PVC) burden
• Presence of the following (number, fastest rate, longest duration)
-Ventricular tachycardia
-Supraventricular tachycardia
• Alert events
-Heart rate >180/min or <40/min
-Pauses >3 seconds
Timepoint [1] 304126 0
At 24 hours, immediately following removal of S-Patch and Holter monitor
Primary outcome [2] 304473 0
Capability of reporting analysis by both devices - analysis performed by cardiologists
Raw data from the S-Patch device will be directly compared to raw data from the traditional Holter monitor, over 24 hours for ambulatory ECG readings.

A Cardiac Physiologist will assess
• Cardiac rhythm (sinus rhythm, atrial fibrillation, atrial flutter, junctional rhythm)
• Minimum, maximum and average heart rate
• Burden of atrial fibrillation and atrial flutter, junctional rhythm
• Premature Ventricular Contraction (PVC) burden
• Presence of the following (number, fastest rate, longest duration)
-Ventricular tachycardia
-Supraventricular tachycardia
• Alert events
-Heart rate >180/min or <40/min
-Pauses >3 seconds
Timepoint [2] 304473 0
At 24 hours, immediately following removal of S-Patch and Holter monitor
Secondary outcome [1] 341039 0
Ease of Use of devices by patient as measured by unvalidated study-specific questionnaire
Timepoint [1] 341039 0
At 24 hours, immediately following removal of S-Patch and Holter monitor
Secondary outcome [2] 341850 0
Perceived comfort of device by patient as measured by unvalidated study-specific questionnaire
Timepoint [2] 341850 0
At 24 hours, immediately following removal of S-Patch and Holter monitor
Secondary outcome [3] 342062 0
Patient's Safety Perceptions as measured by unvalidated study-specific questionnaire.
Timepoint [3] 342062 0
At 24 hours, immediately following removal of S-Patch and Holter monitor.
Secondary outcome [4] 342063 0
Frequency of undesirable events (e.g. Device becoming unattached, excessive noise) as measured by unvalidated study-specific questionnaire completed by cardiologist.
Timepoint [4] 342063 0
At 24 hours, immediately following removal of S-Patch and Holter monitor
Secondary outcome [5] 342064 0
Ease of data access/collection as measured by unvalidated study-specific questionnaire completed by cardiologist..
Timepoint [5] 342064 0
At 24 hours, immediately following removal of S-Patch and Holter monitor
Secondary outcome [6] 342067 0
Ease of device application as measured by unvalidated study-specific questionnaire completed by cardiologist..
Timepoint [6] 342067 0
At 24 hours, immediately following removal of S-Patch and Holter monitor

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria:
- Pacemaker patients that are Pacemaker dependent
- Implantable Cardiac Defibrillator (ICD) patients

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
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.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A Cardiac Physiologist will review the data and detail the Standard of Care findings report and the following additional information.
• Cardiac rhythm (sinus rhythm, atrial fibrillation, atrial flutter, junctional rhythm)
• Minimum, maximum and average heart rate
• Burden of atrial fibrillation and atrial flutter, junctional rhythm
• Premature Ventricular Contraction (PVC) burden
• Presence of the following (number, fastest rate, longest duration)
o Ventricular tachycardia
o Supraventricular tachycardia
• Alert events
o Heart rate >180/min or <40/min
o Pauses >3 seconds

Holter monitor data will be read by a number of different Cardiac Physiologists within the department, and a standard report generated. To minimise the impact of the learning curve when reading the S-Patch data, one dedicated Cardiac Physiologist will read and report on all of the S-Patch data.
Primary outcomes from the evaluation (Investigator) will be used to report incremental cost-effectiveness ratios (ICER). The ICER will be expressed by the difference in costs divided by the difference in effects, and presented as cost ($) per effect with 95% confidence intervals. Probabilistic sensitivity analysis will be performed to test the robustness of the results across a range of possible values.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/03/2017
Date of last participant enrolment
Anticipated
Actual
4/12/2017
Date of last data collection
Anticipated
Actual
5/12/2017
Sample size
Target
90
Accrual to date
Final
90
Recruitment outside Australia
Country [1] 9410 0
New Zealand
State/province [1] 9410 0
Auckland

Funding & Sponsors
Funding source category [1] 298139 0
Charities/Societies/Foundations
Name [1] 298139 0
Middlemore Clinical Trials
Country [1] 298139 0
New Zealand
Primary sponsor type
Hospital
Name
Counties Manukau Health
Address
100 Hospital Rd
Papatoetoe
Auckland 2025
Country
New Zealand
Secondary sponsor category [1] 297224 0
None
Name [1] 297224 0
Address [1] 297224 0
Country [1] 297224 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299159 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 299159 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 299159 0
New Zealand
Date submitted for ethics approval [1] 299159 0
11/11/2016
Approval date [1] 299159 0
30/01/2017
Ethics approval number [1] 299159 0
16/CEN/183

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79498 0
Dr Selwyn Wong
Address 79498 0
Middlemore Clinical Trials
100 Hospital Rd
Papatoetoe
Auckland 2025
Country 79498 0
New Zealand
Phone 79498 0
+64 9 2509869
Fax 79498 0
+64 9 2503878
Email 79498 0
[email protected]
Contact person for public queries
Name 79499 0
Nicole Signal
Address 79499 0
Middlemore Clinical Trials
100 Hospital Rd
Papatoetoe
Auckland 2025
Country 79499 0
New Zealand
Phone 79499 0
+64 9 2509869
Fax 79499 0
+64 9 2503878
Email 79499 0
[email protected]
Contact person for scientific queries
Name 79500 0
Selwyn wong
Address 79500 0
Middlemore Clinical Trials
100 Hospital Rd
Papatoetoe
Auckland 2025
Country 79500 0
New Zealand
Phone 79500 0
+64 9 2509869
Fax 79500 0
+64 9 2503878
Email 79500 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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