Trial Outcomes & Findings for Atrial Fibrillation Algorithms Clinical Validation Study (NCT NCT04699812)

Results Overview

Sensitivity of the irregular rhythm notification for the identification of persons with AF by 13-day ambulatory ECG, with AF defined as at least 30 seconds of AF by ambulatory ECG. Sensitivity is defined as the percentage of subjects exhibiting AF on the ambulatory ECG who also received an irregular rhythm notification concordant with at least one episode of AF.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

573 participants

Primary outcome timeframe

13 DAYS

Results posted on

2022-08-24

Participant Flow

Participant milestones

Participant milestones
Measure	COHORT 1 This will include subjects with no known history of AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 2 This will include subjects with no known history of AF, but with history of frequent premature atrial contractions (PACs), frequent premature ventricular contractions (PVCs), supraventricular tachycardia (SVT), or non-sustained ventricular tachycardia (NSVT) ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 3 This will include subjects with known history of paroxysmal, persistent, or chronic AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 4 Will include subjects with permanent AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION
Overall Study STARTED	78	82	366	47
Overall Study COMPLETED	70	64	304	45
Overall Study NOT COMPLETED	8	18	62	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Atrial Fibrillation Algorithms Clinical Validation Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	COHORT 1 n=78 Participants This will include subjects with no known history of AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 2 n=82 Participants This will include subjects with no known history of AF, but with history of frequent premature atrial contractions (PACs), frequent premature ventricular contractions (PVCs), supraventricular tachycardia (SVT), or non-sustained ventricular tachycardia (NSVT) ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 3 n=366 Participants This will include subjects with known history of paroxysmal, persistent, or chronic AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 4 n=47 Participants Will include subjects with permanent AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	Total n=573 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=5 Participants	45 Participants n=7 Participants	144 Participants n=5 Participants	14 Participants n=4 Participants	263 Participants n=21 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants	37 Participants n=7 Participants	222 Participants n=5 Participants	33 Participants n=4 Participants	310 Participants n=21 Participants
Age, Continuous	49.2 years STANDARD_DEVIATION 16.68 • n=5 Participants	61.2 years STANDARD_DEVIATION 15.07 • n=7 Participants	65.4 years STANDARD_DEVIATION 11.79 • n=5 Participants	70.0 years STANDARD_DEVIATION 8.85 • n=4 Participants	63.0 years STANDARD_DEVIATION 14.09 • n=21 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	53 Participants n=7 Participants	180 Participants n=5 Participants	14 Participants n=4 Participants	287 Participants n=21 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	29 Participants n=7 Participants	186 Participants n=5 Participants	33 Participants n=4 Participants	286 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	18 Participants n=5 Participants	1 Participants n=7 Participants	17 Participants n=5 Participants	2 Participants n=4 Participants	38 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	60 Participants n=5 Participants	81 Participants n=7 Participants	349 Participants n=5 Participants	45 Participants n=4 Participants	535 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	19 Participants n=5 Participants	7 Participants n=7 Participants	27 Participants n=5 Participants	4 Participants n=4 Participants	57 Participants n=21 Participants
Race (NIH/OMB) White	57 Participants n=5 Participants	74 Participants n=7 Participants	330 Participants n=5 Participants	41 Participants n=4 Participants	502 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	78 Participants n=5 Participants	82 Participants n=7 Participants	366 Participants n=5 Participants	47 Participants n=4 Participants	573 Participants n=21 Participants

PRIMARY outcome

Timeframe: 13 DAYS

Population: Per the pre-specified analysis plan, subjects from only Cohorts 1, 3, and 4 were to be included in the analysis. The pre-specified analysis also required the results to be pooled across these 3 cohorts and were not to be reported separately by cohort.

Sensitivity of the irregular rhythm notification for the identification of persons with AF by 13-day ambulatory ECG, with AF defined as at least 30 seconds of AF by ambulatory ECG. Sensitivity is defined as the percentage of subjects exhibiting AF on the ambulatory ECG who also received an irregular rhythm notification concordant with at least one episode of AF.

Outcome measures

Outcome measures
Measure	COHORT 1 n=1 Participants This will include subjects with no known history of AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 2 This will include subjects with no known history of AF, but with history of frequent premature atrial contractions (PACs), frequent premature ventricular contractions (PVCs), supraventricular tachycardia (SVT), or non-sustained ventricular tachycardia (NSVT) ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 3 n=103 Participants This will include subjects with known history of paroxysmal, persistent, or chronic AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 4 n=36 Participants Will include subjects with permanent AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	Overall n=140 Participants Pooled across relevant cohorts per the statistical analysis section of the protocol.
SENSITIVITY OF IRREGULAR RHYTHM NOTIFICATION FEATURE [IRNF]	NA percentage of participants Cohort not analyzed separately per statistical analysis section of the protocol.	—	NA percentage of participants Cohort not analyzed separately per statistical analysis section of the protocol.	NA percentage of participants Cohort not analyzed separately per statistical analysis section of the protocol.	88.6 percentage of participants

PRIMARY outcome

Timeframe: 13 DAYS

Population: Per the pre-specified analysis plan, subjects from only Cohorts 1, 3, and 4 were to be included in the analysis. The pre-specified analysis also required the results to be pooled across these 3 cohorts and were not to be reported separately by cohort.

Specificity of the lack of irregular rhythm notification for the identification of persons without AF by 13-day ambulatory ECG, with AF defined as at least 30 seconds of AF by ambulatory ECG. Specificity is defined as the percentage of subjects not exhibiting AF on the ambulatory ECG who also did not receive any irregular rhythm notifications.

Outcome measures

Outcome measures
Measure	COHORT 1 n=66 Participants This will include subjects with no known history of AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 2 This will include subjects with no known history of AF, but with history of frequent premature atrial contractions (PACs), frequent premature ventricular contractions (PVCs), supraventricular tachycardia (SVT), or non-sustained ventricular tachycardia (NSVT) ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 3 n=219 Participants This will include subjects with known history of paroxysmal, persistent, or chronic AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 4 n=7 Participants Will include subjects with permanent AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	Overall n=292 Participants Pooled across relevant cohorts per the statistical analysis section of the protocol.
SPECIFICITY OF LACK OF IRREGULAR RHYTHM NOTIFICATIONS FEATURE [IRNF]	NA percentage of participants Cohort not analyzed separately per statistical analysis section of the protocol.	—	NA percentage of participants Cohort not analyzed separately per statistical analysis section of the protocol.	NA percentage of participants Cohort not analyzed separately per statistical analysis section of the protocol.	99.3 percentage of participants

PRIMARY outcome

Timeframe: 13 DAYS

Population: Per the pre-specified analysis plan, subjects from only Cohorts 3 and 4 (i.e., those with a prior diagnosis of AF) were to be included in the analysis. The pre-specified analysis also required the results to be pooled across these 2 cohorts and were not to be reported separately by cohort.

Weekly AF burden estimate defined as the percentage of time a subject is in Atrial Fibrillation during wrist device wear over the prior 7 consecutive days. The weekly AF burden was estimated by both the reference device and the algorithm and reported using the Bland-Altman limits of Agreement.

Outcome measures

Outcome measures
Measure	COHORT 1 n=244 Paired Differences This will include subjects with no known history of AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 2 n=36 Paired Differences This will include subjects with no known history of AF, but with history of frequent premature atrial contractions (PACs), frequent premature ventricular contractions (PVCs), supraventricular tachycardia (SVT), or non-sustained ventricular tachycardia (NSVT) ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 3 n=280 Paired Differences This will include subjects with known history of paroxysmal, persistent, or chronic AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 4 Will include subjects with permanent AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	Overall Pooled across relevant cohorts per the statistical analysis section of the protocol.
WEEKLY ATRIAL FIBRILLATION BURDEN FEATURE ESTIMATE [AFBF] Lower Limit of Agreement (%)	NA Bland-Altman Limits of Agreement Cohort not analyzed separately per statistical analysis section of the protocol.	NA Bland-Altman Limits of Agreement Cohort not analyzed separately per statistical analysis section of the protocol.	-11.4 Bland-Altman Limits of Agreement	—	—
WEEKLY ATRIAL FIBRILLATION BURDEN FEATURE ESTIMATE [AFBF] Upper Limit of Agreement (%)	NA Bland-Altman Limits of Agreement Cohort not analyzed separately per statistical analysis section of the protocol.	NA Bland-Altman Limits of Agreement Cohort not analyzed separately per statistical analysis section of the protocol.	12.8 Bland-Altman Limits of Agreement	—	—

SECONDARY outcome

Timeframe: 13 DAYS

Population: Per the pre-specified analysis plan, subjects from only Cohorts 1, 3 and 4 who received a notification were to be included in the analysis. No subjects in Cohort 1 received a notification in the study. The pre-specified analysis also required the results to be pooled across the cohorts and were not to be reported separately by cohort.

Notification-level positive predictive value (PPV) with AF by ambulatory ECG at the time of any tachogram comprising the notification.

Outcome measures

Outcome measures
Measure	COHORT 1 This will include subjects with no known history of AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 2 This will include subjects with no known history of AF, but with history of frequent premature atrial contractions (PACs), frequent premature ventricular contractions (PVCs), supraventricular tachycardia (SVT), or non-sustained ventricular tachycardia (NSVT) ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 3 n=1228 Notifications This will include subjects with known history of paroxysmal, persistent, or chronic AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 4 n=617 Notifications Will include subjects with permanent AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	Overall n=1845 Notifications Pooled across relevant cohorts per the statistical analysis section of the protocol.
POSITIVE PREDICTIVE VALUE OF IRREGULAR RHYTHM NOTIFICATION FEATURE [IRNF]	—	—	NA percentage of notifications Cohort not analyzed separately per statistical analysis section of the protocol.	NA percentage of notifications Cohort not analyzed separately per statistical analysis section of the protocol.	100 percentage of notifications

SECONDARY outcome

Timeframe: 13 DAYS

Population: Per the pre-specified analysis plan, subjects from only Cohorts 1, 3 and 4 were to be included in the analysis if they received a notification during the study. No subjects in Cohort 1 received a notification. The pre-specified analysis also required the results to be pooled across the cohorts and were not to be reported separately by cohort.

Tachogram-level sensitivity performance for tachograms comprising alerts.

Outcome measures

Outcome measures
Measure	COHORT 1 This will include subjects with no known history of AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 2 This will include subjects with no known history of AF, but with history of frequent premature atrial contractions (PACs), frequent premature ventricular contractions (PVCs), supraventricular tachycardia (SVT), or non-sustained ventricular tachycardia (NSVT) ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 3 n=7013 Tachograms This will include subjects with known history of paroxysmal, persistent, or chronic AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 4 n=3518 Tachograms Will include subjects with permanent AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	Overall n=10531 Tachograms Pooled across relevant cohorts per the statistical analysis section of the protocol.
TACHOGRAM ALERT SENSITIVITY [IRNF]	—	—	NA percentage of tachograms Cohort not analyzed separately per statistical analysis section of the protocol.	NA percentage of tachograms Cohort not analyzed separately per statistical analysis section of the protocol.	95.05 percentage of tachograms

SECONDARY outcome

Timeframe: 13 DAYS

Population: Per the pre-specified analysis plan, subjects from only Cohorts 1, 3 and 4 were to be included in the analysis if they received a notification. No subjects in Cohort 1 received a notification during the study. The pre-specified analysis also required the results to be pooled across the cohorts and were not to be reported separately by cohort.

Tachogram-level specificity performance for tachograms comprising alerts.

Outcome measures

Outcome measures
Measure	COHORT 1 This will include subjects with no known history of AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 2 This will include subjects with no known history of AF, but with history of frequent premature atrial contractions (PACs), frequent premature ventricular contractions (PVCs), supraventricular tachycardia (SVT), or non-sustained ventricular tachycardia (NSVT) ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 3 n=2 Tachograms This will include subjects with known history of paroxysmal, persistent, or chronic AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 4 n=5 Tachograms Will include subjects with permanent AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	Overall n=7 Tachograms Pooled across relevant cohorts per the statistical analysis section of the protocol.
TACHOGRAM ALERT SPECIFICITY [IRNF]	—	—	NA percentage of tachograms Cohort not analyzed separately per statistical analysis section of the protocol.	NA percentage of tachograms Cohort not analyzed separately per statistical analysis section of the protocol.	0 percentage of tachograms

SECONDARY outcome

Timeframe: 13 DAYS

Population: Per the pre-specified analysis plan, subjects from only Cohorts 1, 3 and 4 were to be included in the analysis if they received a notification. No subjects in Cohort 1 received a notification during the study. The pre-specified analysis also required the results to be pooled across the cohorts and were not to be reported separately by cohort.

Tachogram-level False Positive rate performance for tachograms comprising alerts.

Outcome measures

Outcome measures
Measure	COHORT 1 This will include subjects with no known history of AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 2 This will include subjects with no known history of AF, but with history of frequent premature atrial contractions (PACs), frequent premature ventricular contractions (PVCs), supraventricular tachycardia (SVT), or non-sustained ventricular tachycardia (NSVT) ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 3 n=8 Tachograms This will include subjects with known history of paroxysmal, persistent, or chronic AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 4 n=9 Tachograms Will include subjects with permanent AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	Overall n=17 Tachograms Pooled across relevant cohorts per the statistical analysis section of the protocol.
Tachogram Alert False Positive Rate [IRNF]	—	—	NA percentage of tachograms Cohort not analyzed separately per statistical analysis section of the protocol.	NA percentage of tachograms Cohort not analyzed separately per statistical analysis section of the protocol.	100 percentage of tachograms

SECONDARY outcome

Timeframe: 13 DAYS

Population: Per the pre-specified analysis plan, subjects from only Cohorts 1, 3 and 4 were to be included in the analysis if they received a notification. No subjects in Cohort 1 received a notification during the study. The pre-specified analysis also required the results to be pooled across the cohorts and were not to be reported separately by cohort.

Tachogram-level Positive Predictive value performance for tachograms comprising alerts.

Outcome measures

Outcome measures
Measure	COHORT 1 This will include subjects with no known history of AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 2 This will include subjects with no known history of AF, but with history of frequent premature atrial contractions (PACs), frequent premature ventricular contractions (PVCs), supraventricular tachycardia (SVT), or non-sustained ventricular tachycardia (NSVT) ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 3 n=6672 Tachograms This will include subjects with known history of paroxysmal, persistent, or chronic AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 4 n=3355 Tachograms Will include subjects with permanent AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	Overall n=10027 Tachograms Pooled across relevant cohorts per the statistical analysis section of the protocol.
Tachogram Alert Positive Predictive Value [IRNF]	—	—	NA percentage of tachograms Cohort not analyzed separately per statistical analysis section of the protocol.	NA percentage of tachograms Cohort not analyzed separately per statistical analysis section of the protocol.	99.83 percentage of tachograms

SECONDARY outcome

Timeframe: 13 DAYS

Population: Per the pre-specified analysis plan, subjects from only Cohorts 1, 3 and 4 were to be included in the analysis if they received a notification. No subjects in Cohort 1 received a notification during the study. The pre-specified analysis also required the results to be pooled across the cohorts and were not to be reported separately by cohort.

Tachogram-level Negative Predictive value performance for tachograms comprising alerts.

Outcome measures

Outcome measures
Measure	COHORT 1 This will include subjects with no known history of AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 2 This will include subjects with no known history of AF, but with history of frequent premature atrial contractions (PACs), frequent premature ventricular contractions (PVCs), supraventricular tachycardia (SVT), or non-sustained ventricular tachycardia (NSVT) ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 3 n=349 Tachograms This will include subjects with known history of paroxysmal, persistent, or chronic AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 4 n=172 Tachograms Will include subjects with permanent AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	Overall n=521 Tachograms Pooled across relevant cohorts per the statistical analysis section of the protocol.
Tachogram Alert Negative Predictive Value [IRNF]	—	—	NA percentage of tachograms Cohort not analyzed separately per statistical analysis section of the protocol.	NA percentage of tachograms Cohort not analyzed separately per statistical analysis section of the protocol.	0 percentage of tachograms

SECONDARY outcome

Timeframe: 13 DAYS

Population: Per the pre-specified analysis plan, subjects from only Cohorts 1, 3 and 4 were to be included in the analysis. The pre-specified analysis also required the results to be pooled across the cohorts and were not to be reported separately by cohort.

Tachogram-level sensitivity performance for all generated tachograms.

Outcome measures

Outcome measures
Measure	COHORT 1 n=8 Tachograms This will include subjects with no known history of AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 2 This will include subjects with no known history of AF, but with history of frequent premature atrial contractions (PACs), frequent premature ventricular contractions (PVCs), supraventricular tachycardia (SVT), or non-sustained ventricular tachycardia (NSVT) ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 3 n=2818 Tachograms This will include subjects with known history of paroxysmal, persistent, or chronic AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 4 n=1663 Tachograms Will include subjects with permanent AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	Overall n=4489 Tachograms Pooled across relevant cohorts per the statistical analysis section of the protocol.
TACHOGRAM SENSITIVITY [IRNF]	NA percentage of tachograms Cohort not analyzed separately per statistical analysis section of the protocol.	—	NA percentage of tachograms Cohort not analyzed separately per statistical analysis section of the protocol.	NA percentage of tachograms Cohort not analyzed separately per statistical analysis section of the protocol.	85.5 percentage of tachograms

SECONDARY outcome

Timeframe: 13 DAYS

Population: Per the pre-specified analysis plan, subjects from only Cohorts 1, 3 and 4 were to be included in the analysis. The pre-specified analysis also required the results to be pooled across the cohorts and were not to be reported separately by cohort.

Tachogram-level specificity performance for all generated tachograms.

Outcome measures

Outcome measures
Measure	COHORT 1 n=685 Tachograms This will include subjects with no known history of AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 2 This will include subjects with no known history of AF, but with history of frequent premature atrial contractions (PACs), frequent premature ventricular contractions (PVCs), supraventricular tachycardia (SVT), or non-sustained ventricular tachycardia (NSVT) ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 3 n=2578 Tachograms This will include subjects with known history of paroxysmal, persistent, or chronic AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 4 n=90 Tachograms Will include subjects with permanent AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	Overall n=3353 Tachograms Pooled across relevant cohorts per the statistical analysis section of the protocol.
TACHOGRAM SPECIFICITY [IRNF]	NA percentage of tachograms Cohort not analyzed separately per statistical analysis section of the protocol.	—	NA percentage of tachograms Cohort not analyzed separately per statistical analysis section of the protocol.	NA percentage of tachograms Cohort not analyzed separately per statistical analysis section of the protocol.	99.9 percentage of tachograms

SECONDARY outcome

Timeframe: 13 DAYS

Tachogram-level false positive rate performance for all generated tachograms.

Outcome measures

Outcome measures
Measure	COHORT 1 n=726 Tachograms This will include subjects with no known history of AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 2 n=5937 Tachograms This will include subjects with no known history of AF, but with history of frequent premature atrial contractions (PACs), frequent premature ventricular contractions (PVCs), supraventricular tachycardia (SVT), or non-sustained ventricular tachycardia (NSVT) ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 3 n=2823 Tachograms This will include subjects with known history of paroxysmal, persistent, or chronic AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 4 n=104 Tachograms Will include subjects with permanent AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	Overall n=3653 Tachograms Pooled across relevant cohorts per the statistical analysis section of the protocol.
TACHOGRAM FALSE POSITIVE RATE [IRNF]	NA percentage of tachograms Cohort not analyzed separately per statistical analysis section of the protocol.	0.05 percentage of tachograms	NA percentage of tachograms Cohort not analyzed separately per statistical analysis section of the protocol.	NA percentage of tachograms Cohort not analyzed separately per statistical analysis section of the protocol.	0.22 percentage of tachograms

SECONDARY outcome

Timeframe: 13 DAYS

Population: Per the pre-specified analysis plan, subjects from only Cohorts 1, 3 and 4 were to be included in the analysis if they had at least one irregular tachogram. No subjects in Cohort 1 had an irregular tachogram. The pre-specified analysis also required the results to be pooled across the cohorts and were not to be reported separately by cohort.

Tachogram-level positive predictive value performance for all generated tachograms.

Outcome measures

Outcome measures
Measure	COHORT 1 This will include subjects with no known history of AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 2 This will include subjects with no known history of AF, but with history of frequent premature atrial contractions (PACs), frequent premature ventricular contractions (PVCs), supraventricular tachycardia (SVT), or non-sustained ventricular tachycardia (NSVT) ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 3 n=2370 Tachograms This will include subjects with known history of paroxysmal, persistent, or chronic AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	COHORT 4 n=1474 Tachograms Will include subjects with permanent AF ELECTROCARDIOGRAM (ECG) PATCH WEAR: ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	Overall n=3844 Tachograms Pooled across relevant cohorts per the statistical analysis section of the protocol.
TACHOGRAM POSITIVE PREDICTIVE VALUE [IRNF]	—	—	NA percentage of tachograms Cohort not analyzed separately per statistical analysis section of the protocol.	NA percentage of tachograms Cohort not analyzed separately per statistical analysis section of the protocol.	99.8 percentage of tachograms

SECONDARY outcome

Timeframe: 13 DAYS

Population: Per the pre-specified analysis plan, subjects from only Cohorts 1, 3 and 4 were to be included in the analysis. The pre-specified analysis also required the results to be pooled across the cohorts and were not to be reported separately by cohort.

Tachogram-level negative predictive value performance for all generated tachograms.