Atrial Fibrillation
Conditions
Keywords
CARDIOVASCULAR DISEASES, HEART DISEASES, ARRHYTHMIA, CARDIAC
Brief summary
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.
Detailed description
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.
Interventions
DEVICEELECTROCARDIOGRAM (ECG) PATCH WEAR
ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION
Sponsors
Iqvia Pty Ltd
Apple Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Able to read, understand, and provide written informed consent 2. Willing and able to participate in the study procedures as described in the consent form 3. Be 22 years of age and older 4. Able to communicate effectively with and follow instructions from the study staff 5. Able to wear the wrist device for duration of study participation 6. For Cohort 1, have no known medical history of AF 7. For Cohort 2, have no known medical history of AF and active diagnosis of at least one of the following arrhythmias within the past 2 years: 1. Frequent PACs, defined as at least 1% of total beats of atrial ectopic beats by 24-48 hour Holter, ambulatory ECG monitor, or implantable loop recorder) 2. Frequent PVCs, defined as at least 1% of total beats of ventricular ectopic beats by 24-48 hour Holter, ambulatory ECG monitor, or implantable loop recorder 3. SVT, which will include atrial tachycardia, atrioventricular nodal re-entrant tachycardia, atrioventricular re-entrant tachycardia by 12-lead ECG or 24-48 hour Holter, ambulatory ECG monitor, or implantable loop recorder 4. NSVT, defined as three or more consecutive ventricular beats at a rate of at least 100 beats per minute and lasting no more than 30 seconds, by 12-lead ECG or 24-48 hour Holter, ambulatory ECG monitor, or implantable loop recorder 8. For Cohorts 3 and 4, have a known diagnosis of AF at the time of screening (confirmed by electronic medical record (EMR) or self-report) and have had a recent episode of AF, or confirmed AF on ECG, in the past 12 months 9. For Cohort 4, have a known diagnosis of permanent AF at the time of screening (confirmed by EMR or self-report) and have had a recent episode of AF, or confirmed AF on ECG, in the past 12 months 10. Meet additional binning based on demographics.
Exclusion criteria
1. Physical disability that precludes safe and adequate testing 2. Mental impairment resulting in limited ability to cooperate 3. Known uncontrolled medical conditions, such as (but not limited to) significant anemia, important electrolyte imbalance and untreated or uncontrolled thyroid disease 4. Open wound(s) on the wrist and/or forearm 5. Tattoos, large moles, or scars on the wrist at the wrist device location 6. Skin conditions on either wrist that would preclude subject from wearing a wristband on either wrist 7. Known allergy or sensitivity to medical adhesives, isopropyl alcohol, wristbands, or ECG patch 8. Medical history or physical assessment finding that makes the subject inappropriate for participation according to investigator(s) 9. Participation in a previous study that used a wrist-worn sensor device with a simultaneous ECG reference patch 10. Implantable cardiac devices such as a Pacemaker or Implantable Cardioverter Defibrillator 11. Clinically significant hand tremors, as judged by the investigator 12. Acute illness including COVID and other respiratory illnesses 13. Subjects with known history of AF on rhythm control medications with history of complete AF rhythm control (i.e history of zero AF burden) will be excluded from Cohorts 3 and 4
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SENSITIVITY OF IRREGULAR RHYTHM NOTIFICATION FEATURE [IRNF] | 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. |
| SPECIFICITY OF LACK OF IRREGULAR RHYTHM NOTIFICATIONS FEATURE [IRNF] | 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. |
| WEEKLY ATRIAL FIBRILLATION BURDEN FEATURE ESTIMATE [AFBF] | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TACHOGRAM ALERT SPECIFICITY [IRNF] | 13 DAYS | Tachogram-level specificity performance for tachograms comprising alerts. |
| Tachogram Alert False Positive Rate [IRNF] | 13 DAYS | Tachogram-level False Positive rate performance for tachograms comprising alerts. |
| Tachogram Alert Positive Predictive Value [IRNF] | 13 DAYS | Tachogram-level Positive Predictive value performance for tachograms comprising alerts. |
| Tachogram Alert Negative Predictive Value [IRNF] | 13 DAYS | Tachogram-level Negative Predictive value performance for tachograms comprising alerts. |
| TACHOGRAM SENSITIVITY [IRNF] | 13 DAYS | Tachogram-level sensitivity performance for all generated tachograms. |
| TACHOGRAM SPECIFICITY [IRNF] | 13 DAYS | Tachogram-level specificity performance for all generated tachograms. |
| TACHOGRAM FALSE POSITIVE RATE [IRNF] | 13 DAYS | Tachogram-level false positive rate performance for all generated tachograms. |
| TACHOGRAM SPECIFICITY [AFBF] | 13 days | Specificity of tachograms for the identification of AF by ambulatory ECG. |
| TACHOGRAM NEGATIVE PREDICTIVE VALUE [IRNF] | 13 DAYS | Tachogram-level negative predictive value performance for all generated tachograms. |
| TACHOGRAM SENSITIVITY [AFBF] | 13 days | Sensitivity of tachograms for the identification of AF by ambulatory ECG. |
| TACHOGRAM POSITIVE PREDICTIVE VALUE [AFBF] | 13 days | Positive Predictive Value of tachograms for the identification of AF by ambulatory ECG. |
| TACHOGRAM NEGATIVE PREDICTIVE VALUE [AFBF] | 13 days | Negative Predictive Value of tachograms for the identification of AF by ambulatory ECG. |
| DAY-SPECIFIC AF BURDEN ESTIMATE [AFBF] | 13 DAYS | Day-specific AF burden estimate defined as the percentage of time a subject is in Atrial Fibrillation during a specific day of the week. |
| FOUR-HOUR SEGMENT SPECIFIC AF BURDEN ESTIMATE [AFBF] | 13 DAYS | Four-hour segment-specific AF burden estimate defined as the percentage of time a subject is in Atrial Fibrillation during a specific four-hour segment of a day |
| TACHOGRAM POSITIVE PREDICTIVE VALUE [IRNF] | 13 DAYS | Tachogram-level positive predictive value performance for all generated tachograms. |
| POSITIVE PREDICTIVE VALUE OF IRREGULAR RHYTHM NOTIFICATION FEATURE [IRNF] | 13 DAYS | Notification-level positive predictive value (PPV) with AF by ambulatory ECG at the time of any tachogram comprising the notification. |
| TACHOGRAM ALERT SENSITIVITY [IRNF] | 13 DAYS | Tachogram-level sensitivity performance for tachograms comprising alerts. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 78 |
| 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 | 82 |
| 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 | 366 |
| 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 | 47 |
| Total | 573 |
Baseline characteristics
| Characteristic | COHORT 1 | COHORT 2 | COHORT 3 | COHORT 4 | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 37 Participants | 222 Participants | 33 Participants | 310 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants | 45 Participants | 144 Participants | 14 Participants | 263 Participants |
| Age, Continuous | 49.2 years STANDARD_DEVIATION 16.68 | 61.2 years STANDARD_DEVIATION 15.07 | 65.4 years STANDARD_DEVIATION 11.79 | 70.0 years STANDARD_DEVIATION 8.85 | 63.0 years STANDARD_DEVIATION 14.09 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants | 1 Participants | 17 Participants | 2 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 60 Participants | 81 Participants | 349 Participants | 45 Participants | 535 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 7 Participants | 27 Participants | 4 Participants | 57 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 5 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 57 Participants | 74 Participants | 330 Participants | 41 Participants | 502 Participants |
| Region of Enrollment United States | 78 Participants | 82 Participants | 366 Participants | 47 Participants | 573 Participants |
| Sex: Female, Male Female | 40 Participants | 53 Participants | 180 Participants | 14 Participants | 287 Participants |
| Sex: Female, Male Male | 38 Participants | 29 Participants | 186 Participants | 33 Participants | 286 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 78 | 0 / 82 | 0 / 366 | 0 / 47 |
| other Total, other adverse events | 3 / 78 | 11 / 82 | 46 / 366 | 3 / 47 |
| serious Total, serious adverse events | 0 / 78 | 0 / 82 | 7 / 366 | 0 / 47 |
Outcome results
Primary
SENSITIVITY OF IRREGULAR RHYTHM NOTIFICATION FEATURE [IRNF]
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| COHORT 1 | SENSITIVITY OF IRREGULAR RHYTHM NOTIFICATION FEATURE [IRNF] | NA percentage of participants |
| COHORT 3 | SENSITIVITY OF IRREGULAR RHYTHM NOTIFICATION FEATURE [IRNF] | NA percentage of participants |
| COHORT 4 | SENSITIVITY OF IRREGULAR RHYTHM NOTIFICATION FEATURE [IRNF] | NA percentage of participants |
| Overall | SENSITIVITY OF IRREGULAR RHYTHM NOTIFICATION FEATURE [IRNF] | 88.6 percentage of participants |
Primary
SPECIFICITY OF LACK OF IRREGULAR RHYTHM NOTIFICATIONS FEATURE [IRNF]
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| COHORT 1 | SPECIFICITY OF LACK OF IRREGULAR RHYTHM NOTIFICATIONS FEATURE [IRNF] | NA percentage of participants |
| COHORT 3 | SPECIFICITY OF LACK OF IRREGULAR RHYTHM NOTIFICATIONS FEATURE [IRNF] | NA percentage of participants |
| COHORT 4 | SPECIFICITY OF LACK OF IRREGULAR RHYTHM NOTIFICATIONS FEATURE [IRNF] | NA percentage of participants |
| Overall | SPECIFICITY OF LACK OF IRREGULAR RHYTHM NOTIFICATIONS FEATURE [IRNF] | 99.3 percentage of participants |
Primary
WEEKLY ATRIAL FIBRILLATION BURDEN FEATURE ESTIMATE [AFBF]
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COHORT 1 | WEEKLY ATRIAL FIBRILLATION BURDEN FEATURE ESTIMATE [AFBF] | Lower Limit of Agreement (%) | NA Bland-Altman Limits of Agreement |
| COHORT 1 | WEEKLY ATRIAL FIBRILLATION BURDEN FEATURE ESTIMATE [AFBF] | Upper Limit of Agreement (%) | NA Bland-Altman Limits of Agreement |
| COHORT 2 | WEEKLY ATRIAL FIBRILLATION BURDEN FEATURE ESTIMATE [AFBF] | Lower Limit of Agreement (%) | NA Bland-Altman Limits of Agreement |
| COHORT 2 | WEEKLY ATRIAL FIBRILLATION BURDEN FEATURE ESTIMATE [AFBF] | Upper Limit of Agreement (%) | NA Bland-Altman Limits of Agreement |
| COHORT 3 | WEEKLY ATRIAL FIBRILLATION BURDEN FEATURE ESTIMATE [AFBF] | Lower Limit of Agreement (%) | -11.4 Bland-Altman Limits of Agreement |
| COHORT 3 | WEEKLY ATRIAL FIBRILLATION BURDEN FEATURE ESTIMATE [AFBF] | Upper Limit of Agreement (%) | 12.8 Bland-Altman Limits of Agreement |
Secondary
DAY-SPECIFIC AF BURDEN ESTIMATE [AFBF]
Day-specific AF burden estimate defined as the percentage of time a subject is in Atrial Fibrillation during a specific day of the week.
Time frame: 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 the cohorts and were not to be reported separately by cohort.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| COHORT 1 | DAY-SPECIFIC AF BURDEN ESTIMATE [AFBF] | NA percent of iterations achieving success |
| COHORT 2 | DAY-SPECIFIC AF BURDEN ESTIMATE [AFBF] | NA percent of iterations achieving success |
| COHORT 3 | DAY-SPECIFIC AF BURDEN ESTIMATE [AFBF] | 62.5 percent of iterations achieving success |
Secondary
FOUR-HOUR SEGMENT SPECIFIC AF BURDEN ESTIMATE [AFBF]
Four-hour segment-specific AF burden estimate defined as the percentage of time a subject is in Atrial Fibrillation during a specific four-hour segment of a day
Time frame: 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 the cohorts and were not to be reported separately by cohort.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| COHORT 1 | FOUR-HOUR SEGMENT SPECIFIC AF BURDEN ESTIMATE [AFBF] | NA percent of iterations achieving success |
| COHORT 2 | FOUR-HOUR SEGMENT SPECIFIC AF BURDEN ESTIMATE [AFBF] | NA percent of iterations achieving success |
| COHORT 3 | FOUR-HOUR SEGMENT SPECIFIC AF BURDEN ESTIMATE [AFBF] | 99.95 percent of iterations achieving success |
Secondary
POSITIVE PREDICTIVE VALUE OF IRREGULAR RHYTHM NOTIFICATION FEATURE [IRNF]
Notification-level positive predictive value (PPV) with AF by ambulatory ECG at the time of any tachogram comprising the notification.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| COHORT 3 | POSITIVE PREDICTIVE VALUE OF IRREGULAR RHYTHM NOTIFICATION FEATURE [IRNF] | NA percentage of notifications |
| COHORT 4 | POSITIVE PREDICTIVE VALUE OF IRREGULAR RHYTHM NOTIFICATION FEATURE [IRNF] | NA percentage of notifications |
| Overall | POSITIVE PREDICTIVE VALUE OF IRREGULAR RHYTHM NOTIFICATION FEATURE [IRNF] | 100 percentage of notifications |
Secondary
Tachogram Alert False Positive Rate [IRNF]
Tachogram-level False Positive rate performance for tachograms comprising alerts.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| COHORT 3 | Tachogram Alert False Positive Rate [IRNF] | NA percentage of tachograms |
| COHORT 4 | Tachogram Alert False Positive Rate [IRNF] | NA percentage of tachograms |
| Overall | Tachogram Alert False Positive Rate [IRNF] | 100 percentage of tachograms |
Secondary
Tachogram Alert Negative Predictive Value [IRNF]
Tachogram-level Negative Predictive value performance for tachograms comprising alerts.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| COHORT 3 | Tachogram Alert Negative Predictive Value [IRNF] | NA percentage of tachograms |
| COHORT 4 | Tachogram Alert Negative Predictive Value [IRNF] | NA percentage of tachograms |
| Overall | Tachogram Alert Negative Predictive Value [IRNF] | 0 percentage of tachograms |
Secondary
Tachogram Alert Positive Predictive Value [IRNF]
Tachogram-level Positive Predictive value performance for tachograms comprising alerts.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| COHORT 3 | Tachogram Alert Positive Predictive Value [IRNF] | NA percentage of tachograms |
| COHORT 4 | Tachogram Alert Positive Predictive Value [IRNF] | NA percentage of tachograms |
| Overall | Tachogram Alert Positive Predictive Value [IRNF] | 99.83 percentage of tachograms |
Secondary
TACHOGRAM ALERT SENSITIVITY [IRNF]
Tachogram-level sensitivity performance for tachograms comprising alerts.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| COHORT 3 | TACHOGRAM ALERT SENSITIVITY [IRNF] | NA percentage of tachograms |
| COHORT 4 | TACHOGRAM ALERT SENSITIVITY [IRNF] | NA percentage of tachograms |
| Overall | TACHOGRAM ALERT SENSITIVITY [IRNF] | 95.05 percentage of tachograms |
Secondary
TACHOGRAM ALERT SPECIFICITY [IRNF]
Tachogram-level specificity performance for tachograms comprising alerts.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| COHORT 3 | TACHOGRAM ALERT SPECIFICITY [IRNF] | NA percentage of tachograms |
| COHORT 4 | TACHOGRAM ALERT SPECIFICITY [IRNF] | NA percentage of tachograms |
| Overall | TACHOGRAM ALERT SPECIFICITY [IRNF] | 0 percentage of tachograms |
Secondary
TACHOGRAM FALSE POSITIVE RATE [IRNF]
Tachogram-level false positive rate performance for all generated tachograms.
Time frame: 13 DAYS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| COHORT 1 | TACHOGRAM FALSE POSITIVE RATE [IRNF] | NA percentage of tachograms |
| COHORT 2 | TACHOGRAM FALSE POSITIVE RATE [IRNF] | 0.05 percentage of tachograms |
| COHORT 3 | TACHOGRAM FALSE POSITIVE RATE [IRNF] | NA percentage of tachograms |
| COHORT 4 | TACHOGRAM FALSE POSITIVE RATE [IRNF] | NA percentage of tachograms |
| Overall | TACHOGRAM FALSE POSITIVE RATE [IRNF] | 0.22 percentage of tachograms |
Secondary
TACHOGRAM NEGATIVE PREDICTIVE VALUE [AFBF]
Negative Predictive Value of tachograms for the identification of AF by ambulatory ECG.
Time frame: 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 the cohorts and were not to be reported separately by cohort.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| COHORT 1 | TACHOGRAM NEGATIVE PREDICTIVE VALUE [AFBF] | NA percentage of tachograms |
| COHORT 2 | TACHOGRAM NEGATIVE PREDICTIVE VALUE [AFBF] | NA percentage of tachograms |
| COHORT 3 | TACHOGRAM NEGATIVE PREDICTIVE VALUE [AFBF] | 97.1 percentage of tachograms |
Secondary
TACHOGRAM NEGATIVE PREDICTIVE VALUE [IRNF]
Tachogram-level negative predictive value performance for all generated tachograms.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| COHORT 1 | TACHOGRAM NEGATIVE PREDICTIVE VALUE [IRNF] | NA percentage of tachograms |
| COHORT 3 | TACHOGRAM NEGATIVE PREDICTIVE VALUE [IRNF] | NA percentage of tachograms |
| COHORT 4 | TACHOGRAM NEGATIVE PREDICTIVE VALUE [IRNF] | NA percentage of tachograms |
| Overall | TACHOGRAM NEGATIVE PREDICTIVE VALUE [IRNF] | 77.9 percentage of tachograms |
Secondary
TACHOGRAM POSITIVE PREDICTIVE VALUE [AFBF]
Positive Predictive Value of tachograms for the identification of AF by ambulatory ECG.
Time frame: 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 the cohorts and were not to be reported separately by cohort.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| COHORT 1 | TACHOGRAM POSITIVE PREDICTIVE VALUE [AFBF] | NA percentage of tachograms |
| COHORT 2 | TACHOGRAM POSITIVE PREDICTIVE VALUE [AFBF] | NA percentage of tachograms |
| COHORT 3 | TACHOGRAM POSITIVE PREDICTIVE VALUE [AFBF] | 96.7 percentage of tachograms |
Secondary
TACHOGRAM POSITIVE PREDICTIVE VALUE [IRNF]
Tachogram-level positive predictive value performance for all generated tachograms.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| COHORT 3 | TACHOGRAM POSITIVE PREDICTIVE VALUE [IRNF] | NA percentage of tachograms |
| COHORT 4 | TACHOGRAM POSITIVE PREDICTIVE VALUE [IRNF] | NA percentage of tachograms |
| Overall | TACHOGRAM POSITIVE PREDICTIVE VALUE [IRNF] | 99.8 percentage of tachograms |
Secondary
TACHOGRAM SENSITIVITY [AFBF]
Sensitivity of tachograms for the identification of AF by ambulatory ECG.
Time frame: 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 the cohorts and were not to be reported separately by cohort.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| COHORT 1 | TACHOGRAM SENSITIVITY [AFBF] | NA percentage of tachograms |
| COHORT 2 | TACHOGRAM SENSITIVITY [AFBF] | NA percentage of tachograms |
| COHORT 3 | TACHOGRAM SENSITIVITY [AFBF] | 92.6 percentage of tachograms |
Secondary
TACHOGRAM SENSITIVITY [IRNF]
Tachogram-level sensitivity performance for all generated tachograms.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| COHORT 1 | TACHOGRAM SENSITIVITY [IRNF] | NA percentage of tachograms |
| COHORT 3 | TACHOGRAM SENSITIVITY [IRNF] | NA percentage of tachograms |
| COHORT 4 | TACHOGRAM SENSITIVITY [IRNF] | NA percentage of tachograms |
| Overall | TACHOGRAM SENSITIVITY [IRNF] | 85.5 percentage of tachograms |
Secondary
TACHOGRAM SPECIFICITY [AFBF]
Specificity of tachograms for the identification of AF by ambulatory ECG.
Time frame: 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 the cohorts and were not to be reported separately by cohort.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| COHORT 1 | TACHOGRAM SPECIFICITY [AFBF] | NA percentage of tachograms |
| COHORT 2 | TACHOGRAM SPECIFICITY [AFBF] | NA percentage of tachograms |
| COHORT 3 | TACHOGRAM SPECIFICITY [AFBF] | 98.8 percentage of tachograms |
Secondary
TACHOGRAM SPECIFICITY [IRNF]
Tachogram-level specificity performance for all generated tachograms.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| COHORT 1 | TACHOGRAM SPECIFICITY [IRNF] | NA percentage of tachograms |
| COHORT 3 | TACHOGRAM SPECIFICITY [IRNF] | NA percentage of tachograms |
| COHORT 4 | TACHOGRAM SPECIFICITY [IRNF] | NA percentage of tachograms |
| Overall | TACHOGRAM SPECIFICITY [IRNF] | 99.9 percentage of tachograms |