Trial Outcomes & Findings for Diagnostic Accuracy of WEARable TECHnology Single-lead ECG in Detecting Cardiac Arrhythmias (NCT NCT05298553)
NCT ID: NCT05298553
Last Updated: 2026-06-01
Results Overview
Assessment of diagnostic accuracy of SkyLabs CART-I ring and Apple Watch 1-lead ECGs interpretation for for atrial fibrillaiton compared with a 12-lead ECG (gold-standard).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
500 participants
Primary outcome timeframe
1 Day
Results posted on
2026-06-01
Participant Flow
Participant milestones
| Measure |
Group 1
The order in which the wearable devices being investigated will be randomly assigned in a 1:1 fashion.
Simultaneous 12-lead ECG and single-lead ECG with the SkyLabs CART-I ring followed by the Apple Watch.
Group A: Participants will be asked to perform a simultaneous 30-seconds 12-lead ECG and single-lead ECG for each wearable device: Skylab CART-I ring followed by Apple Watch.
|
Group 2
The order in which the wearable devices being investigated will be randomly assigned in a 1:1 fashion.
Simultaneous 12-lead ECG and single-lead ECG with the Apple Watch followed by the SkyLabs CART-I ring.
Group B: they will be asked to perform a simultaneous 30-seconds 12-lead ECG and single-lead ECG for each wearable device: Apple Watch followed by the Skylab CART-I ring.
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|---|---|---|
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Overall Study
STARTED
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249
|
249
|
|
Overall Study
COMPLETED
|
249
|
249
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1
n=498 Participants
The order in which the wearable devices being investigated will be randomly assigned in a 1:1 fashion.
Simultaneous 12-lead ECG and single-lead ECG with the SkyLabs CART-I ring followed by the Apple Watch.
Group A: Participants will be asked to perform a simultaneous 30-seconds 12-lead ECG and single-lead ECG for each wearable device: Skylab CART-I ring followed by Apple Watch.
Group B: Participants will be asked to perform a simultaneous 30-seconds 12-lead ECG and single-lead ECG for each wearable device: Apple Watch followed by Apple Watch.
|
|---|---|
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Age, Continuous
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66 years
n=498 Participants
|
|
Sex: Female, Male
Female
|
142 Participants
n=498 Participants
|
|
Sex: Female, Male
Male
|
356 Participants
n=498 Participants
|
|
BMI
|
27.8 Kg/m2
n=498 Participants
|
|
Ischaemic Heart Disease
|
113 Participants
n=498 Participants
|
|
Myocardial Infarction
|
68 Participants
n=498 Participants
|
|
Atrial Fibrillation
|
303 Participants
n=498 Participants
|
|
Atrial Tachycardia/Flutter
|
59 Participants
n=498 Participants
|
|
Congestive Cardiac Failure
|
109 Participants
n=498 Participants
|
|
Hypertension
|
156 Participants
n=498 Participants
|
|
Valvular Heart Disease
|
90 Participants
n=498 Participants
|
|
Cardiac Surgery
|
59 Participants
n=498 Participants
|
|
CIED
|
47 Participants
n=498 Participants
|
|
Stroke/TIA
|
30 Participants
n=498 Participants
|
PRIMARY outcome
Timeframe: 1 DayPopulation: Diagnostic performance for Atrial Fibrillation
Assessment of diagnostic accuracy of SkyLabs CART-I ring and Apple Watch 1-lead ECGs interpretation for for atrial fibrillaiton compared with a 12-lead ECG (gold-standard).
Outcome measures
| Measure |
Apple Watch
n=498 single-leads ECG
Diagnostic performance of the Apple Watch
|
CART Ring
n=498 single-leads ECG
Diagnostic performance of the CART Ring
|
|---|---|---|
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Compare the Diagnostic Performance of Physician Rhythm Interpretation of 1-lead ECG Generated by SkyLabs CART-I Ring and Apple Watch Versus 12-lead ECG (Gold-standard) for Atrial Fibrillation
Specificity
|
89.8 Percentage of cases
Interval 85.9 to 92.7
|
88.8 Percentage of cases
Interval 84.8 to 91.9
|
|
Compare the Diagnostic Performance of Physician Rhythm Interpretation of 1-lead ECG Generated by SkyLabs CART-I Ring and Apple Watch Versus 12-lead ECG (Gold-standard) for Atrial Fibrillation
Sensitvity
|
95.4 Percentage of cases
Interval 91.4 to 97.5
|
94.3 Percentage of cases
Interval 90.1 to 96.8
|
|
Compare the Diagnostic Performance of Physician Rhythm Interpretation of 1-lead ECG Generated by SkyLabs CART-I Ring and Apple Watch Versus 12-lead ECG (Gold-standard) for Atrial Fibrillation
PPV
|
85.6 Percentage of cases
Interval 80.3 to 89.7
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84.3 Percentage of cases
Interval 78.9 to 88.6
|
|
Compare the Diagnostic Performance of Physician Rhythm Interpretation of 1-lead ECG Generated by SkyLabs CART-I Ring and Apple Watch Versus 12-lead ECG (Gold-standard) for Atrial Fibrillation
NPV
|
96.8 Percentage of cases
Interval 94.0 to 98.3
|
96.1 Percentage of cases
Interval 93.1 to 97.8
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SECONDARY outcome
Timeframe: 1 DayAssessment of diagnostic accuracy of the AF detection algorithm of the Skylab CART-I ring and Apple Watch compared to a 12-lead ECG (gold-standard).
Outcome measures
| Measure |
Apple Watch
n=498 Participants
Diagnostic performance of the Apple Watch
|
CART Ring
n=498 Participants
Diagnostic performance of the CART Ring
|
|---|---|---|
|
Compare the Accuracy of Automatic AF Detection of the SkyLabs CART-I Ring and Apple Watch Versus a Cardiologist Interpretation of a 12-lead ECG (Gold-standard)
Sensitivity
|
69.1 Perecenages of cases
Interval 62.6 to 75.6
|
84.6 Perecenages of cases
Interval 79.6 to 89.7
|
|
Compare the Accuracy of Automatic AF Detection of the SkyLabs CART-I Ring and Apple Watch Versus a Cardiologist Interpretation of a 12-lead ECG (Gold-standard)
Specificity
|
70.7 Perecenages of cases
Interval 65.6 to 75.8
|
89.4 Perecenages of cases
Interval 86.0 to 92.9
|
|
Compare the Accuracy of Automatic AF Detection of the SkyLabs CART-I Ring and Apple Watch Versus a Cardiologist Interpretation of a 12-lead ECG (Gold-standard)
PPV
|
60.1 Perecenages of cases
Interval 53.7 to 66.5
|
83.8 Perecenages of cases
Interval 78.6 to 88.9
|
|
Compare the Accuracy of Automatic AF Detection of the SkyLabs CART-I Ring and Apple Watch Versus a Cardiologist Interpretation of a 12-lead ECG (Gold-standard)
NPV
|
78.2 Perecenages of cases
Interval 73.0 to 83.1
|
89.5 Perecenages of cases
Interval 86.5 to 92.5
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SECONDARY outcome
Timeframe: 1 DayLevel of agreement of measured interval duration between the SkyLabs CART-I ring, Apple Watch 1-lead ECG and a 12-lead ECG.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 DayCorrelation coefficient between the mean heart rate from simultaneous single lead and 12 lead ECG acquisitions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 DayAssessmen of diagnostic accuracy of the Skylab CART-I ring if a PPG signal is added.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 DayAssessment of diagnostic accuracy of the AF detection algorithm of the Skylab CART-I ring and Apple Watch compared to a 12-lead ECG (gold-standard) with Unclassified SL-ECG were excluded
Outcome measures
| Measure |
Apple Watch
n=396 Participants
Diagnostic performance of the Apple Watch
|
CART Ring
n=489 Participants
Diagnostic performance of the CART Ring
|
|---|---|---|
|
Compare the Accuracy of Automatic AF Detection of the SkyLabs CART-I Ring and Apple Watch Versus a Cardiologist Interpretation of a 12-lead ECG (Gold-standard) - Unclassified Excluded
Sensitivity
|
84.8 Percentage of cases
Interval 79.2 to 90.4
|
86.4 Percentage of cases
Interval 81.5 to 91.3
|
|
Compare the Accuracy of Automatic AF Detection of the SkyLabs CART-I Ring and Apple Watch Versus a Cardiologist Interpretation of a 12-lead ECG (Gold-standard) - Unclassified Excluded
Specificity
|
92.9 Percentage of cases
Interval 89.6 to 96.1
|
88.9 Percentage of cases
Interval 85.4 to 92.5
|
|
Compare the Accuracy of Automatic AF Detection of the SkyLabs CART-I Ring and Apple Watch Versus a Cardiologist Interpretation of a 12-lead ECG (Gold-standard) - Unclassified Excluded
PPV
|
88.7 Percentage of cases
Interval 83.7 to 93.8
|
83.3 Percentage of cases
Interval 78.1 to 88.5
|
|
Compare the Accuracy of Automatic AF Detection of the SkyLabs CART-I Ring and Apple Watch Versus a Cardiologist Interpretation of a 12-lead ECG (Gold-standard) - Unclassified Excluded
NPV
|
90.2 Percentage of cases
Interval 86.5 to 93.9
|
91.1 Percentage of cases
Interval 87.8 to 94.3
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Adverse Events
Apple Watch
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CART Ring
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Andre Briosa e Gala - EP Research Fellow
Oxford University Hospitals NHS Foundation Trust
Phone: 0300 304 7777
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place