Trial Outcomes & Findings for Electrocardiogram Clinical Validation Study (NCT NCT03492554)
NCT ID: NCT03492554
Last Updated: 2020-12-03
Results Overview
Specificity of rhythm classification
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
602 participants
Primary outcome timeframe
1 Day
Results posted on
2020-12-03
Participant Flow
Participant milestones
| Measure |
Atrial Fibrillation (AF)
Patient with a known history of AF who is in AF at the time of study screening.
1-Lead ECG: All participants will record three single-lead ECGs
12-Lead ECG: All participants will simultaneously record three 12-lead ECGs
|
Normal Sinus Rhythm (SR)
Patient with no known diagnosis of AF or other arrhythmia
1-Lead ECG: All participants will record three single-lead ECGs
12-Lead ECG: All participants will simultaneously record three 12-lead ECGs
|
|---|---|---|
|
Overall Study
STARTED
|
301
|
301
|
|
Overall Study
COMPLETED
|
301
|
287
|
|
Overall Study
NOT COMPLETED
|
0
|
14
|
Reasons for withdrawal
| Measure |
Atrial Fibrillation (AF)
Patient with a known history of AF who is in AF at the time of study screening.
1-Lead ECG: All participants will record three single-lead ECGs
12-Lead ECG: All participants will simultaneously record three 12-lead ECGs
|
Normal Sinus Rhythm (SR)
Patient with no known diagnosis of AF or other arrhythmia
1-Lead ECG: All participants will record three single-lead ECGs
12-Lead ECG: All participants will simultaneously record three 12-lead ECGs
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
14
|
Baseline Characteristics
Electrocardiogram Clinical Validation Study
Baseline characteristics by cohort
| Measure |
Atrial Fibrillation (AF)
n=301 Participants
Patient with a known history of AF who is in AF at the time of study screening.
1-Lead ECG: All participants will record three single-lead ECGs
12-Lead ECG: All participants will simultaneously record three 12-lead ECGs
|
Normal Sinus Rhythm (SR)
n=287 Participants
Patient with no known diagnosis of AF or other arrhythmia
1-Lead ECG: All participants will record three single-lead ECGs
12-Lead ECG: All participants will simultaneously record three 12-lead ECGs
|
Total
n=588 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.8 years
STANDARD_DEVIATION 8.62 • n=99 Participants
|
59.5 years
STANDARD_DEVIATION 17.73 • n=107 Participants
|
66.9 years
STANDARD_DEVIATION 15.47 • n=206 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=99 Participants
|
159 Participants
n=107 Participants
|
251 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
209 Participants
n=99 Participants
|
128 Participants
n=107 Participants
|
337 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity : Hispanic or Latino
|
19 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity : Not Hispanic or Latino
|
282 Participants
n=99 Participants
|
230 Participants
n=107 Participants
|
512 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race: American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race: Asian
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race: Black or African American
|
8 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race: Native Hawaiian or Other Pacific Islanders
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race: White
|
292 Participants
n=99 Participants
|
236 Participants
n=107 Participants
|
528 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race: Not Reported
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
301 Participants
n=99 Participants
|
287 Participants
n=107 Participants
|
588 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 DayPopulation: Classifiable Analysis Set: All subjects who had readable/classifiable paired Software and Reference strips were used. This analysis set was used for analyzing the primary endpoints of sensitivity and specificity.
Specificity of rhythm classification
Outcome measures
| Measure |
Normal Sinus Rhythm (SR)
n=239 Participants
Patient with no known diagnosis of AF or other arrhythmia
1-Lead ECG: All participants will record three single-lead ECGs
12-Lead ECG: All participants will simultaneously record three 12-lead ECGs
|
Normal Sinus Rhythm (SR)
Patient with no known diagnosis of AF or other arrhythmia
1-Lead ECG: All participants will record three single-lead ECGs
12-Lead ECG: All participants will simultaneously record three 12-lead ECGs
|
|---|---|---|
|
Number of Participants With Software's Rhythm Classification of SR in Agreement to a Physician's Interpretation of a Gold Standard 12-lead ECG
|
238 Participants
|
—
|
PRIMARY outcome
Timeframe: 1 DayPopulation: Classifiable Analysis Set: All subjects who had readable/classifiable paired Software and Reference strips were used. This analysis set was used for analyzing the primary endpoints of sensitivity and specificity.
Sensitivity of rhythm classification
Outcome measures
| Measure |
Normal Sinus Rhythm (SR)
n=240 Participants
Patient with no known diagnosis of AF or other arrhythmia
1-Lead ECG: All participants will record three single-lead ECGs
12-Lead ECG: All participants will simultaneously record three 12-lead ECGs
|
Normal Sinus Rhythm (SR)
Patient with no known diagnosis of AF or other arrhythmia
1-Lead ECG: All participants will record three single-lead ECGs
12-Lead ECG: All participants will simultaneously record three 12-lead ECGs
|
|---|---|---|
|
Number of Participants With Software's Rhythm Classification of AF in Agreement to a Physician's Interpretation of a Gold Standard 12-lead ECG
|
236 Participants
|
—
|
SECONDARY outcome
Timeframe: 1 DayPopulation: Waveform Assessment Analysis Set: Paired Software and Reference strips collected from subjects were randomly selected. If 6 consecutive paired beats for analysis cannot be found in these strips, they were excluded from further analysis. This analysis set was used for assessing the quality of the clinical waveform.
Number of ECGs that pass a visual overlay
Outcome measures
| Measure |
Normal Sinus Rhythm (SR)
n=61 Participants
Patient with no known diagnosis of AF or other arrhythmia
1-Lead ECG: All participants will record three single-lead ECGs
12-Lead ECG: All participants will simultaneously record three 12-lead ECGs
|
Normal Sinus Rhythm (SR)
n=65 Participants
Patient with no known diagnosis of AF or other arrhythmia
1-Lead ECG: All participants will record three single-lead ECGs
12-Lead ECG: All participants will simultaneously record three 12-lead ECGs
|
|---|---|---|
|
Number of Participants With Software's Ability to Produce a Clinically Equivalent Waveform in Agreement to a Gold Standard Lead 1 Reference
|
60 Participants
|
65 Participants
|
SECONDARY outcome
Timeframe: 1 DayPopulation: Waveform Assessment Analysis Set: Paired Software and Reference strips collected from subjects were randomly selected. If 6 consecutive paired beats for analysis cannot be found in these strips, they were excluded from further analysis. This analysis set was used for assessing the quality of the clinical waveform.
Difference in R-wave amplitudes between the software and gold standard reference
Outcome measures
| Measure |
Normal Sinus Rhythm (SR)
n=61 Participants
Patient with no known diagnosis of AF or other arrhythmia
1-Lead ECG: All participants will record three single-lead ECGs
12-Lead ECG: All participants will simultaneously record three 12-lead ECGs
|
Normal Sinus Rhythm (SR)
n=65 Participants
Patient with no known diagnosis of AF or other arrhythmia
1-Lead ECG: All participants will record three single-lead ECGs
12-Lead ECG: All participants will simultaneously record three 12-lead ECGs
|
|---|---|---|
|
Number of Participants With Software's Ability to Produce a Clinically Equivalent Waveform in Agreement to a Gold Standard Lead 1 Reference
|
58 Participants
|
65 Participants
|
SECONDARY outcome
Timeframe: 1 DayAverage ease of use on a 1 (Unable to Use) to 5 (Easiest to Use) scale
Outcome measures
| Measure |
Normal Sinus Rhythm (SR)
n=301 Participants
Patient with no known diagnosis of AF or other arrhythmia
1-Lead ECG: All participants will record three single-lead ECGs
12-Lead ECG: All participants will simultaneously record three 12-lead ECGs
|
Normal Sinus Rhythm (SR)
n=287 Participants
Patient with no known diagnosis of AF or other arrhythmia
1-Lead ECG: All participants will record three single-lead ECGs
12-Lead ECG: All participants will simultaneously record three 12-lead ECGs
|
|---|---|---|
|
Ease of Use
1 = Unable to Use
|
2 Participants
|
1 Participants
|
|
Ease of Use
2 = Below Average Ease of Use
|
4 Participants
|
2 Participants
|
|
Ease of Use
3 = Average Ease of Use
|
14 Participants
|
16 Participants
|
|
Ease of Use
4 = Above Average Ease of Use
|
41 Participants
|
29 Participants
|
|
Ease of Use
5 = Easiest to Use
|
240 Participants
|
239 Participants
|
Adverse Events
Atrial Fibrillation (AF)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Sinus Rhythm (SR)
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place