22 and older, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
SENSITIVITY OF IRREGULAR RHYTHM NOTIFICATION FEATURE [IRNF]Primary· 13 DAYS
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.
Group
Value
95% CI
COHORT 1
NA
COHORT 3
NA
COHORT 4
NA
Overall
88.6
SPECIFICITY OF LACK OF IRREGULAR RHYTHM NOTIFICATIONS FEATURE [IRNF]Primary· 13 DAYS
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.
Group
Value
95% CI
COHORT 1
NA
COHORT 3
NA
COHORT 4
NA
Overall
99.3
WEEKLY ATRIAL FIBRILLATION BURDEN FEATURE ESTIMATE [AFBF]Primary· 13 DAYS
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.
Lower Limit of Agreement (%)
Group
Value
95% CI
COHORT 3
NA
COHORT 4
NA
Overall
-11.4
Upper Limit of Agreement (%)
Group
Value
95% CI
COHORT 3
NA
COHORT 4
NA
Overall
12.8
POSITIVE PREDICTIVE VALUE OF IRREGULAR RHYTHM NOTIFICATION FEATURE [IRNF]Secondary· 13 DAYS
Notification-level positive predictive value (PPV) with AF by ambulatory ECG at the time of any tachogram comprising the notification.
Group
Value
95% CI
COHORT 3
NA
COHORT 4
NA
Overall
100
TACHOGRAM ALERT SENSITIVITY [IRNF]Secondary· 13 DAYS
Tachogram-level sensitivity performance for tachograms comprising alerts.
Group
Value
95% CI
COHORT 3
NA
COHORT 4
NA
Overall
95.05
TACHOGRAM ALERT SPECIFICITY [IRNF]Secondary· 13 DAYS
Tachogram-level specificity performance for tachograms comprising alerts.
Group
Value
95% CI
COHORT 3
NA
COHORT 4
NA
Overall
0
Tachogram Alert False Positive Rate [IRNF]Secondary· 13 DAYS
Tachogram-level False Positive rate performance for tachograms comprising alerts.
Group
Value
95% CI
COHORT 3
NA
COHORT 4
NA
Overall
100
Tachogram Alert Positive Predictive Value [IRNF]Secondary· 13 DAYS
Tachogram-level Positive Predictive value performance for tachograms comprising alerts.
Group
Value
95% CI
COHORT 3
NA
COHORT 4
NA
Overall
99.83
Tachogram Alert Negative Predictive Value [IRNF]Secondary· 13 DAYS
Tachogram-level Negative Predictive value performance for tachograms comprising alerts.
Group
Value
95% CI
COHORT 3
NA
COHORT 4
NA
Overall
0
TACHOGRAM SENSITIVITY [IRNF]Secondary· 13 DAYS
Tachogram-level sensitivity performance for all generated tachograms.
Group
Value
95% CI
COHORT 1
NA
COHORT 3
NA
COHORT 4
NA
Overall
85.5
TACHOGRAM SPECIFICITY [IRNF]Secondary· 13 DAYS
Tachogram-level specificity performance for all generated tachograms.
Group
Value
95% CI
COHORT 1
NA
COHORT 3
NA
COHORT 4
NA
Overall
99.9
TACHOGRAM FALSE POSITIVE RATE [IRNF]Secondary· 13 DAYS
Tachogram-level false positive rate performance for all generated tachograms.
Group
Value
95% CI
COHORT 1
NA
COHORT 2
0.05
COHORT 3
NA
COHORT 4
NA
Overall
0.22
Adverse events — posted to ClinicalTrials.gov
Time frame: 3.5 months.
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of the study is to evaluate the performances of investigational Irregular Rhythm Notification Feature (version 2.0) and Atrial Fibrillation History Feature algorithms.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Apple Inc.
Last refreshed: 24 August 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04699812.