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| Name | Class |
|---|---|
| IQVIA Pty Ltd | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COHORT 1 | Other | This will include subjects with no known history of AF |
|
| COHORT 2 | Other | 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) |
|
| COHORT 3 | Other | This will include subjects with known history of paroxysmal, persistent, or chronic AF |
|
| COHORT 4 | Other | Will include subjects with permanent AF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELECTROCARDIOGRAM (ECG) PATCH WEAR | Device | ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 13 DAYS |
| 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. | 13 DAYS |
| 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. | 13 DAYS |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 13 DAYS |
| TACHOGRAM ALERT SENSITIVITY [IRNF] |
Not provided
Inclusion Criteria:
Able to read, understand, and provide written informed consent
Willing and able to participate in the study procedures as described in the consent form
Be 22 years of age and older
Able to communicate effectively with and follow instructions from the study staff
Able to wear the wrist device for duration of study participation
For Cohort 1, have no known medical history of AF
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:
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
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
Meet additional binning based on demographics.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Tsay, MD, PhD | Apple Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research of South Florida | Coral Gables | Florida | 33134 | United States | ||
| American Health Network of Indiana Llc |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | COHORT 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | percentage of participants | 13 DAYS |
|
3.5 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA (23.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Health Product Clinician | Apple Inc. | 866-905-5303 | htclinicalquestions@apple.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 9, 2021 | Jul 1, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
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| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
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|
Tachogram-level sensitivity performance for tachograms comprising alerts. |
| 13 DAYS |
| TACHOGRAM ALERT SPECIFICITY [IRNF] | Tachogram-level specificity performance for tachograms comprising alerts. | 13 DAYS |
| Tachogram Alert False Positive Rate [IRNF] | Tachogram-level False Positive rate performance for tachograms comprising alerts. | 13 DAYS |
| Tachogram Alert Positive Predictive Value [IRNF] | Tachogram-level Positive Predictive value performance for tachograms comprising alerts. | 13 DAYS |
| Tachogram Alert Negative Predictive Value [IRNF] | Tachogram-level Negative Predictive value performance for tachograms comprising alerts. | 13 DAYS |
| TACHOGRAM SENSITIVITY [IRNF] | Tachogram-level sensitivity performance for all generated tachograms. | 13 DAYS |
| TACHOGRAM SPECIFICITY [IRNF] | Tachogram-level specificity performance for all generated tachograms. | 13 DAYS |
| TACHOGRAM FALSE POSITIVE RATE [IRNF] | Tachogram-level false positive rate performance for all generated tachograms. | 13 DAYS |
| TACHOGRAM POSITIVE PREDICTIVE VALUE [IRNF] | Tachogram-level positive predictive value performance for all generated tachograms. | 13 DAYS |
| TACHOGRAM NEGATIVE PREDICTIVE VALUE [IRNF] | Tachogram-level negative predictive value performance for all generated tachograms. | 13 DAYS |
| TACHOGRAM SENSITIVITY [AFBF] | Sensitivity of tachograms for the identification of AF by ambulatory ECG. | 13 days |
| TACHOGRAM SPECIFICITY [AFBF] | Specificity of tachograms for the identification of AF by ambulatory ECG. | 13 days |
| TACHOGRAM POSITIVE PREDICTIVE VALUE [AFBF] | Positive Predictive Value of tachograms for the identification of AF by ambulatory ECG. | 13 days |
| TACHOGRAM NEGATIVE PREDICTIVE VALUE [AFBF] | Negative Predictive Value of tachograms for the identification of AF by ambulatory ECG. | 13 days |
| 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. | 13 DAYS |
| 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 | 13 DAYS |
| Avon |
| Indiana |
| 46123 |
| United States |
| Heartland Cardiology Webb | Wichita | Kansas | 67226 | United States |
| Healtheast | Saint Paul | Minnesota | 55012 | United States |
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
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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 |
| OG002 | 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 |
| OG003 | 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 |
| OG004 | Overall | Pooled across relevant cohorts per the statistical analysis section of the protocol. |
|
|
| 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. | 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. | Posted | Number | percentage of participants | 13 DAYS |
|
|
|
| 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. | 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. | Posted | Number | Bland-Altman Limits of Agreement | 13 DAYS | Paired Differences | Paired Differences |
|
|
|
| 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. | 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. | Posted | Number | percentage of notifications | 13 DAYS | Notifications | Notifications |
|
|
|
| Secondary | TACHOGRAM ALERT SENSITIVITY [IRNF] | Tachogram-level sensitivity performance for tachograms comprising alerts. | 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. | Posted | Number | percentage of tachograms | 13 DAYS | Tachograms | Tachograms |
|
|
|
| Secondary | TACHOGRAM ALERT SPECIFICITY [IRNF] | Tachogram-level specificity performance for tachograms comprising alerts. | 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. | Posted | Number | percentage of tachograms | 13 DAYS | Tachograms | Tachograms |
|
|
|
| Secondary | Tachogram Alert False Positive Rate [IRNF] | Tachogram-level False Positive rate performance for tachograms comprising alerts. | 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. | Posted | Number | percentage of tachograms | 13 DAYS | Tachograms | Tachograms |
|
|
|
| Secondary | Tachogram Alert Positive Predictive Value [IRNF] | Tachogram-level Positive Predictive value performance for tachograms comprising alerts. | 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. | Posted | Number | percentage of tachograms | 13 DAYS | Tachograms | Tachograms |
|
|
|
| Secondary | Tachogram Alert Negative Predictive Value [IRNF] | Tachogram-level Negative Predictive value performance for tachograms comprising alerts. | 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. | Posted | Number | percentage of tachograms | 13 DAYS | Tachograms | Tachograms |
|
|
|
| Secondary | TACHOGRAM SENSITIVITY [IRNF] | Tachogram-level sensitivity performance for all generated tachograms. | 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. | Posted | Number | percentage of tachograms | 13 DAYS | Tachograms | Tachograms |
|
|
|
| Secondary | TACHOGRAM SPECIFICITY [IRNF] | Tachogram-level specificity performance for all generated tachograms. | 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. | Posted | Number | percentage of tachograms | 13 DAYS | Tachograms | Tachograms |
|
|
|
| Secondary | TACHOGRAM FALSE POSITIVE RATE [IRNF] | Tachogram-level false positive rate performance for all generated tachograms. | Posted | Number | percentage of tachograms | 13 DAYS | Tachograms | Tachograms |
|
|
|
| Secondary | TACHOGRAM POSITIVE PREDICTIVE VALUE [IRNF] | Tachogram-level positive predictive value performance for all generated tachograms. | 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. | Posted | Number | percentage of tachograms | 13 DAYS | Tachograms | Tachograms |
|
|
|
| Secondary | TACHOGRAM NEGATIVE PREDICTIVE VALUE [IRNF] | Tachogram-level negative predictive value performance for all generated tachograms. | 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. | Posted | Number | percentage of tachograms | 13 DAYS | Tachograms | Tachograms |
|
|
|
| Secondary | TACHOGRAM SENSITIVITY [AFBF] | Sensitivity of tachograms for the identification of AF by ambulatory ECG. | 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. | Posted | Number | percentage of tachograms | 13 days | Tachograms | Tachograms |
|
|
|
| Secondary | TACHOGRAM SPECIFICITY [AFBF] | Specificity of tachograms for the identification of AF by ambulatory ECG. | 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. | Posted | Number | percentage of tachograms | 13 days | Tachograms | Tachograms |
|
|
|
| Secondary | TACHOGRAM POSITIVE PREDICTIVE VALUE [AFBF] | Positive Predictive Value of tachograms for the identification of AF by ambulatory ECG. | 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. | Posted | Number | percentage of tachograms | 13 days | Tachograms | Tachograms |
|
|
|
| Secondary | TACHOGRAM NEGATIVE PREDICTIVE VALUE [AFBF] | Negative Predictive Value of tachograms for the identification of AF by ambulatory ECG. | 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. | Posted | Number | percentage of tachograms | 13 days | Tachograms | Tachograms |
|
|
|
| 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. | 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. | Posted | Number | percent of iterations achieving success | 13 DAYS | Simulation Iterations | Simulation Iterations |
|
|
|
| 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 | 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. | Posted | Number | percent of iterations achieving success | 13 DAYS | Simulation Iterations | Simulation Iterations |
|
|
|
| 0 |
| 78 |
| 0 |
| 78 |
| 3 |
| 78 |
| EG001 | 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 | 0 | 82 | 0 | 82 | 11 | 82 |
| EG002 | 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 | 0 | 366 | 7 | 366 | 46 | 366 |
| EG003 | 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 | 0 | 47 | 0 | 47 | 3 | 47 |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Non-systematic Assessment |
|
| COVID-19 pneumonia | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
|
| Metabolic encephalopathy | Nervous system disorders | MedDRA (23.1) | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA (23.1) | Non-systematic Assessment |
|
| Dementia/Asthenia | Nervous system disorders | MedDRA (23.1) | Non-systematic Assessment |
|
| Sinus node dysfunction | Cardiac disorders | MedDRA (23.1) | Non-systematic Assessment |
|
Not provided
Not provided
| D004568 | Electrodiagnosis |
| Upper Limit of Agreement (%) |
|
| Notifications |
|
| Tachograms |
|
| Tachograms |
|
| Tachograms |
|
| Tachograms |
|
| Tachograms |
|
| Tachograms |
|
| Tachograms |
|
| Tachograms |
|
| Tachograms |
|
| Tachograms |
|