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| ID | Type | Description | Link |
|---|---|---|---|
| 48787 | Other Identifier | Stanford IRB |
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This post-marketing study is conducted to characterize the ability of Apple Watch rhythm analysis software to identify Atrial Fibrillation (AF) and facilitate subsequent clinical evaluation among users who contact AppleCare.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ambulatory ECG | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambulatory ECG | Device | Eligible participants are asked to wear the ambulatory ECG monitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Atrial Fibrillation or Atrial Flutter (AF) of at Least 30 Seconds Duration | Detected on ambulatory ECG patch monitor for a participant who received an IRN or Apple Watch ECG app - AFib classification | During ambulatory ECG Monitoring (up to 8 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Arrhythmias Other Than AF | Detected on an ambulatory ECG patch monitor for a participant who received an IRN or Apple Watch ECG app - AFib classification | During ambulatory ECG Monitoring (up to 8 days) |
| Self-reported Contact With Healthcare Provider |
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Inclusion Criteria:
Possession of the following at time of eligibility screening:
At least one of the following by self-report before consent:
Age ≥ 22 years at time of eligibility screening
Current resident of the United States at time of eligibility screening, and will reside in the United States for the length of the study
Proficient in written and spoken English
Valid phone number associated with iPhone, ascertained from self-report
Valid email address, ascertained from self-report
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marco V Perez, MD | Stanford University | Principal Investigator |
| Minang (Mintu) Turakhia, MD, MAS | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94304 | United States |
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Participants who received an irregular pulse notification or who had an AF classification on the ECG app and then called the sponsor's customer support were invited to download the study app and enroll. They had a remote study visit, were sent an ECG patch to wear and return for analysis, and had a second remote visit to review the findings.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ambulatory ECG | Ambulatory ECG: Eligible participants are asked to wear the ambulatory ECG monitor |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ambulatory ECG | Ambulatory ECG: Eligible participants are asked to wear the ambulatory ECG monitor |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Atrial Fibrillation or Atrial Flutter (AF) of at Least 30 Seconds Duration | Detected on ambulatory ECG patch monitor for a participant who received an IRN or Apple Watch ECG app - AFib classification | Posted | Number | 95% Confidence Interval | Proportion of participants | During ambulatory ECG Monitoring (up to 8 days) |
|
|
9 months (participants may have reported adverse events at any time from enrollment to close of study)
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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 | Ambulatory ECG | Ambulatory ECG: Eligible participants are asked to wear the ambulatory ECG monitor |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
The small number of enrolled participants prevents us from drawing meaningful conclusions from this study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marco Perez, Associate Professor of Medicine | Stanford University | (650) 723-9363 | mvperez@stanford.edu |
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| 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 | Nov 13, 2018 | Sep 24, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015716 | Electrocardiography, Ambulatory |
| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
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| Between 15 to 90 days following enrollment |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Arrhythmias Other Than AF | Detected on an ambulatory ECG patch monitor for a participant who received an IRN or Apple Watch ECG app - AFib classification | Posted | Number | 95% Confidence Interval | Proportion of participants | During ambulatory ECG Monitoring (up to 8 days) |
|
|
|
| Secondary | Self-reported Contact With Healthcare Provider | Posted | Number | 95% Confidence Interval | Proportion of participants | Between 15 to 90 days following enrollment |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 4 |
| 17 |
| Elevated Heart Rate | Cardiac disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
| D018670 | Monitoring, Ambulatory |
| D008991 | Monitoring, Physiologic |