Trial Outcomes & Findings for ECG App Algorithms Clinical Validation Study (NCT NCT04247581)
NCT ID: NCT04247581
Last Updated: 2021-09-28
Results Overview
Specificity of sinus rhythm classification
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
546 participants
Primary outcome timeframe
1 Day
Results posted on
2021-09-28
Participant Flow
Participant milestones
| Measure |
Cohort 1
This will include subjects with no known history of AF and are in normal sinus rhythm at time of screening
1-lead ECG: 1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise.
Intervention Other: Exercise - All participants will undergo three trials of exercise.
Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions.
|
Cohort 2
This will include subjects with known persistent or permanent AF who are in AF at the time of screening
1-lead ECG: 1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise.
Intervention Other: Exercise - All participants will undergo three trials of exercise.
Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions.
|
|---|---|---|
|
Overall Study
STARTED
|
241
|
305
|
|
Overall Study
COMPLETED
|
241
|
293
|
|
Overall Study
NOT COMPLETED
|
0
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ECG App Algorithms Clinical Validation Study
Baseline characteristics by cohort
| Measure |
Cohort 1
n=241 Participants
This will include subjects with no known history of AF and are in normal sinus rhythm at time of screening
1-lead ECG: 1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise.
Intervention Other: Exercise - All participants will undergo three trials of exercise.
Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions.
|
Cohort 2
n=305 Participants
This will include subjects with known persistent or permanent AF who are in AF at the time of screening
1-lead ECG: 1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise.
Intervention Other: Exercise - All participants will undergo three trials of exercise.
Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions.
|
Total
n=546 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
207 Participants
n=99 Participants
|
80 Participants
n=107 Participants
|
287 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
34 Participants
n=99 Participants
|
225 Participants
n=107 Participants
|
259 Participants
n=206 Participants
|
|
Age, Continuous
|
43.1 Years
STANDARD_DEVIATION 15.92 • n=99 Participants
|
69.7 Years
STANDARD_DEVIATION 9.35 • n=107 Participants
|
58.0 Years
STANDARD_DEVIATION 18.32 • n=206 Participants
|
|
Sex: Female, Male
Female
|
129 Participants
n=99 Participants
|
76 Participants
n=107 Participants
|
205 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=99 Participants
|
229 Participants
n=107 Participants
|
341 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Hispanic or Latino
|
99 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
170 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Not Hispanic or Latino
|
142 Participants
n=99 Participants
|
234 Participants
n=107 Participants
|
376 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race: American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race: Asian
|
13 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race: Black or African American
|
35 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race: Native Hawaiian or Other Pacific Islander
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race: White
|
185 Participants
n=99 Participants
|
298 Participants
n=107 Participants
|
483 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race: More than one race
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race: Not Reported
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
241 participants
n=99 Participants
|
305 participants
n=107 Participants
|
546 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 DayPopulation: Subjects in each cohort include up to 2 trial measurements (at rest; after exercise). Overall number of units represents the number of trials rather than number of subjects.
Specificity of sinus rhythm classification
Outcome measures
| Measure |
Cohort 1
n=429 Trials
This will include subjects with no known history of AF and are in normal sinus rhythm at time of screening
1-lead ECG: 1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise.
Intervention Other: Exercise - All participants will undergo three trials of exercise.
Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions.
|
Cohort 2
n=10 Trials
This will include subjects with known persistent or permanent AF who are in AF at the time of screening
1-lead ECG: 1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise.
Intervention Other: Exercise - All participants will undergo three trials of exercise.
Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions.
|
|---|---|---|
|
Percentage of Trials With Correct Classification of Normal Sinus Rhythm on Simultaneous 12-lead ECG as "Sinus Rhythm" or "High Heart Rate" on a Readable and Classifiable ECG App Strip.
|
99.3 percentage of trials
|
100 percentage of trials
|
PRIMARY outcome
Timeframe: 1 DayPopulation: Subjects in each cohort include up to 2 trial measurements (at rest; after exercise). Overall number of units represents the number of trials rather than number of subjects.
Sensitivity of sinus rhythm classification
Outcome measures
| Measure |
Cohort 1
n=1 Trials
This will include subjects with no known history of AF and are in normal sinus rhythm at time of screening
1-lead ECG: 1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise.
Intervention Other: Exercise - All participants will undergo three trials of exercise.
Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions.
|
Cohort 2
n=480 Trials
This will include subjects with known persistent or permanent AF who are in AF at the time of screening
1-lead ECG: 1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise.
Intervention Other: Exercise - All participants will undergo three trials of exercise.
Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions.
|
|---|---|---|
|
Percentage of Trials With Correct Classification of AF on Simultaneous 12-lead ECG as "AF" on a Readable and Classifiable ECG App Strip.
|
100 percentage of trials
|
98.5 percentage of trials
|
SECONDARY outcome
Timeframe: 1 DayPopulation: Subjects in each cohort include up to 2 trial measurements (at rest; after exercise). Overall number of units represents the number of trials rather than number of subjects.
Outcome measures
| Measure |
Cohort 1
n=228 Trials
This will include subjects with no known history of AF and are in normal sinus rhythm at time of screening
1-lead ECG: 1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise.
Intervention Other: Exercise - All participants will undergo three trials of exercise.
Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions.
|
Cohort 2
n=6 Trials
This will include subjects with known persistent or permanent AF who are in AF at the time of screening
1-lead ECG: 1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise.
Intervention Other: Exercise - All participants will undergo three trials of exercise.
Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions.
|
|---|---|---|
|
Percentage of Trials With Correct Classification of Normal Sinus Rhythm at Normal Heart Rates as "Sinus Rhythm" on a Readable and Classifiable ECG App Strip
|
98.2 percentage of trials
|
100 percentage of trials
|
SECONDARY outcome
Timeframe: 1 DayPopulation: Subjects in each cohort include up to 2 trial measurements (at rest; after exercise). Overall number of units represents the number of trials rather than number of subjects.
Outcome measures
| Measure |
Cohort 1
n=1 Trials
This will include subjects with no known history of AF and are in normal sinus rhythm at time of screening
1-lead ECG: 1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise.
Intervention Other: Exercise - All participants will undergo three trials of exercise.
Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions.
|
Cohort 2
n=274 Trials
This will include subjects with known persistent or permanent AF who are in AF at the time of screening
1-lead ECG: 1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise.
Intervention Other: Exercise - All participants will undergo three trials of exercise.
Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions.
|
|---|---|---|
|
Percentage of Trials With Correct Classification of AF at Normal Heart Rates as "AF" on a Readable and Classifiable ECG App Strip
|
100 percentage of trials
|
98.9 percentage of trials
|
SECONDARY outcome
Timeframe: 1 DayPopulation: Subjects in each cohort include up to 2 trial measurements (at rest; after exercise). Overall number of units represents the number of trials rather than number of subjects.
Outcome measures
| Measure |
Cohort 1
n=201 Trials
This will include subjects with no known history of AF and are in normal sinus rhythm at time of screening
1-lead ECG: 1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise.
Intervention Other: Exercise - All participants will undergo three trials of exercise.
Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions.
|
Cohort 2
n=4 Trials
This will include subjects with known persistent or permanent AF who are in AF at the time of screening
1-lead ECG: 1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise.
Intervention Other: Exercise - All participants will undergo three trials of exercise.
Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions.
|
|---|---|---|
|
Percentage of Trials With Correct Classification of Sinus Tachycardia at High Heart Rates as "High Heart Rate" on a Readable and Classifiable ECG App Strip
|
90.5 percentage of trials
|
100 percentage of trials
|
SECONDARY outcome
Timeframe: 1 DayPopulation: Subjects in each cohort include up to 2 trial measurements (at rest; after exercise). Overall number of units represents the number of trials rather than number of subjects.
Outcome measures
| Measure |
Cohort 1
This will include subjects with no known history of AF and are in normal sinus rhythm at time of screening
1-lead ECG: 1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise.
Intervention Other: Exercise - All participants will undergo three trials of exercise.
Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions.
|
Cohort 2
n=206 Trials
This will include subjects with known persistent or permanent AF who are in AF at the time of screening
1-lead ECG: 1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise.
Intervention Other: Exercise - All participants will undergo three trials of exercise.
Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions.
|
|---|---|---|
|
Percentage of Trials With Correct Classification of AF at High Heart Rates as "AF (High Heart Rate)" on a Readable and Classifiable ECG App Strip
|
—
|
83 percentage of trials
|
SECONDARY outcome
Timeframe: 1 DayA "pass" rating is given when the waveforms of the ECG tracings generated by the algorithm and the Lead 1 of the 12-Lead ECG appear to overlay to the unaided eye. The morphology of the waveforms will be considered equivalent if at least 80% of the paired waveforms for the first 6 PQRST complexes are given a "pass" rating.
Outcome measures
| Measure |
Cohort 1
n=84 Trials
This will include subjects with no known history of AF and are in normal sinus rhythm at time of screening
1-lead ECG: 1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise.
Intervention Other: Exercise - All participants will undergo three trials of exercise.
Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions.
|
Cohort 2
n=94 Trials
This will include subjects with known persistent or permanent AF who are in AF at the time of screening
1-lead ECG: 1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise.
Intervention Other: Exercise - All participants will undergo three trials of exercise.
Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions.
|
|---|---|---|
|
Percentage of Trials With Equivalence of the ECG App Waveform to Lead I From a 12-lead ECG as Measured by Acceptable Morphology of PQRST Complexes
|
100 percentage of trials
|
100 percentage of trials
|
SECONDARY outcome
Timeframe: 1 DayPopulation: Subjects in each cohort include up to 2 trial measurements (at rest; after exercise). Overall number of units represents the number of trials rather than number of subjects.
A "pass" rating is given when the difference of the R-wave amplitudes (typically the highest peak of one cardiac rhythm cycle) between the ECG tracings generated by the algorithm and the Lead 1 of the 12-Lead ECG is \<= 2mm. The R-wave amplitude agreement will be considered equivalent if at least 80% of the largest R-wave amplitudes of the paired waveforms are given a "pass" rating.
Outcome measures
| Measure |
Cohort 1
n=84 Trials
This will include subjects with no known history of AF and are in normal sinus rhythm at time of screening
1-lead ECG: 1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise.
Intervention Other: Exercise - All participants will undergo three trials of exercise.
Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions.
|
Cohort 2
n=94 Trials
This will include subjects with known persistent or permanent AF who are in AF at the time of screening
1-lead ECG: 1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise.
Intervention Other: Exercise - All participants will undergo three trials of exercise.
Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions.
|
|---|---|---|
|
Percentage of Trials With Equivalence of the ECG App Waveform to Lead I From a 12-lead ECG as Measured by R-Wave Amplitude Agreement
|
96.4 percentage of trials
|
97.9 percentage of trials
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=241 participants at risk
This will include subjects with no known history of AF and are in normal sinus rhythm at time of screening
1-lead ECG: 1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise.
Intervention Other: Exercise - All participants will undergo three trials of exercise.
Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions.
|
Cohort 2
n=305 participants at risk
This will include subjects with known persistent or permanent AF who are in AF at the time of screening
1-lead ECG: 1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise.
Intervention Other: Exercise - All participants will undergo three trials of exercise.
Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Contact Dermatitis
|
0.41%
1/241 • Number of events 1 • 1 Day
|
0.00%
0/305 • 1 Day
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER