Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621000849897
Ethics application status
Approved
Date submitted
26/04/2021
Date registered
1/07/2021
Date last updated
1/07/2021
Date data sharing statement initially provided
1/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A Proof Of Concept study to evaluate the sensitivity and specificity of Wearable and Artificial Intelligence Technology for Chronic Heart Disease used in detecting irregular heart rhythm of patients with Atrial Fibrillation, The “POC WATCH AF” study
Scientific title
A Proof Of Concept study to evaluate the sensitivity and specificity of Wearable and Artificial Intelligence Technology for Chronic Heart Disease used in detecting irregular heart rhythm of patients with Atrial Fibrillation.
Secondary ID [1] 304045 0
SAIIV-CIP-03
Universal Trial Number (UTN)
Trial acronym
POC-WATCH-AF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac arrhythmia 321677 0
Atrial Fibrillation 321678 0
Condition category
Condition code
Cardiovascular 319423 319423 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a proof-of-concept study of a wearable vital signs monitor and App. The primary objective of the trial is to test the hypothesis that the Saiiv Morphic sensors (singularly or in combination), at various anatomical locations, are able to accurately detect atrial fibrillation and measure blood pressure and vascular stiffness compared to standard measurement techniques.

Vital signs will be measured in 30 participants including 15 with atrial fibrillation and 15 with sinus rhythm. Once consented, all participants will be monitored over a 15 minute period. The study will occur in the hospital/ward setting and in ICU.

Participants will lay supine. For the duration of the study participants will be fitted with a 5 lead ECG, one morphic dot over the heart, one morphic dot on the lower sternum, a central blood pressure monitor on the finger (Finapres) and arterial line to measure blood pressure will be in situ as part of routine standard of care.

For 1 minute in a series the participant will have the following fitted to measure vital signs and sounds; a digital stethoscope, echocardiogram, Sphygmocor device (measuring arterial stiffness), morphic dot on writs, morphic dot and band on neck, morphic dot on suprasternal notch and morphic dot on temple.
Intervention code [1] 320362 0
Early Detection / Screening
Comparator / control treatment
Vital signs from the investigational product will be compared with gold standard vital sign monitoring equipment including radial artery cannulation (if participant is cannulated as part of routine medical management) or non-invasive continuous blood pressure monitoring, ECG, echocardiogram and digital stethoscope.
Control group
Active

Outcomes
Primary outcome [1] 327280 0
Sensitivity of Saiiv morphic sensors to detection of cardiac rhythm (atrial fibrillation or sinus rhythm) of the heart at various anatomical locations compared to 5 lead ECG .
Timepoint [1] 327280 0
Day 1
Primary outcome [2] 327817 0
Sensitivity of Saiiv morphic sensors to measure blood pressure at various anatomical locations compared to gold standard radial artery cannulation or non-invasive central blood pressure monitoring.
Timepoint [2] 327817 0
Day 1
Primary outcome [3] 327818 0
Sensitivity of Saiiv morphic sensors to measure vascular stiffness compared to gold standard pulse wave analysis.
Timepoint [3] 327818 0
Day 1
Secondary outcome [1] 394456 0
Heart rate will be compared between the morphic sensors and ECG.
Timepoint [1] 394456 0
Day 1
Secondary outcome [2] 394457 0
Respiratory rate will be compared between the morphic sensors and counting respiratory rate over a 1 minute period.
Timepoint [2] 394457 0
Day 1
Secondary outcome [3] 394458 0
Detect changes in cardiac mechanical function between the morphic sensors and echocardiogram.
Timepoint [3] 394458 0
Day 1
Secondary outcome [4] 394459 0
Accuracy of detecting cardiac structural changes such as valvular disease in those participants with a prior history of structural cardiac damage. Cardiac structural changes will be compared between the morphic sensors and echocardiogram, digital stethoscope and ECG.
Timepoint [4] 394459 0
Day 1.
Secondary outcome [5] 394460 0
Accuracy of detecting auscultation sounds of heart compared between the morphic sensors and digital stethoscope.
Timepoint [5] 394460 0
Day 1
Secondary outcome [6] 394461 0
Accuracy of detecting auscultation sounds of the lungs compared between the morphic sensors and digital stethoscope.
Timepoint [6] 394461 0
Day 1
Secondary outcome [7] 394462 0
Accuracy of detecting auscultation sounds of bowels compared between the morphic sensors and digital stethoscope.
Timepoint [7] 394462 0
Day 1
Secondary outcome [8] 394463 0
Accuracy of detecting auscultation sounds of the vessels compared between the morphic sensors and digital stethoscope.
Timepoint [8] 394463 0
Day 1

Eligibility
Key inclusion criteria
• Male or female age equal to or greater than 18 years of age in ICU – 15 patients with atrial fibrillation and 15 in sinus rhythm (may have hypertension or indications of heart failure).
• In the opinion of the Principal Investigator is a suitable candidate for the study.
• Ability to apply morphic sensors at all locations (heart, suprasternal notch, neck, wrist, lower sternum, and temple).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Episodes of AF or SR that cannot be documented on ECG.
• Participating in con-current clinical trial which has not met its primary endpoint or in the investigators opinion participation in this study could affect the primary endpoint of the concurrent study.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
As per the Clinical Trial Handbook [15] pre-market pilot studies including proof of concept studies typically recruits 10-30 participants. Consequently 30 participants will be recruited into this trial in order to obtain 15 samples of data in both AF and SR. All participants enrolled in the study will be evaluated. Statistics will be presented descriptively and using Lin's concordance correlation coefficient (CCC).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/07/2021
Actual
Date of last participant enrolment
Anticipated
31/08/2021
Actual
Date of last data collection
Anticipated
31/08/2021
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19178 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 33750 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 308426 0
Commercial sector/Industry
Name [1] 308426 0
Medical Monitoring Solutions Pty Ltd
Country [1] 308426 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medical Monitoring Solutions Pty Ltd
Address
Suite 1402B, 275 Alfred Street, North Sydney, NSW. 2060, Australia.
Country
Australia
Secondary sponsor category [1] 309261 0
None
Name [1] 309261 0
Address [1] 309261 0
Country [1] 309261 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308387 0
South Western Sydney Local Health District
Ethics committee address [1] 308387 0
Level 2, UNSW Clinical School
Liverpool Hospital,
NSW, 2070,
Ethics committee country [1] 308387 0
Australia
Date submitted for ethics approval [1] 308387 0
27/01/2021
Approval date [1] 308387 0
08/04/2021
Ethics approval number [1] 308387 0

Summary
Brief summary
The purpose of this trial is to test the specificity and sensitivity of two types of sensors, used in the Saiiv device, in detecting AF when compared to ECG. Other vital signs including blood pressure (and related arterial stiffness) as well as mechanical performance of the heart will also be measured and compared with standard measurement techniques.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110538 0
Prof Anders Aneman
Address 110538 0
Intensive Care Unit
Liverpool Hospital
Locked Bag 7103
Liverpool BC NSW 1871
Country 110538 0
Australia
Phone 110538 0
+61 2 8738 3400
Fax 110538 0
+61 2 8738 3551
Email 110538 0
[email protected]
Contact person for public queries
Name 110539 0
Mr Neil Anderson
Address 110539 0
Medical Monitoring Solutions
Suite 1402B, 275 Alfred Street,
North Sydney, NSW, 2060
Country 110539 0
Australia
Phone 110539 0
+61 2 8317 5460
Fax 110539 0
+61 2 8317 5461
Email 110539 0
[email protected]
Contact person for scientific queries
Name 110540 0
Mr Neil Anderson
Address 110540 0
Medical Monitoring Solutions
Suite 1402B, 275 Alfred Street,
North Sydney, NSW, 2060
Country 110540 0
Australia
Phone 110540 0
+61 2 8317 5460
Fax 110540 0
+61 2 8317 5461
Email 110540 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Commercial in Confidence. Data will be published in a scientific journal.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.