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It was decided by Verily Leadership to not pursue the study any further.
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This study is designed to evaluate the performance of the Verily Watch Cardio for recording electrocardiogram (ECG) and photoplethysmography (PPG) signals and detecting suspected atrial fibrillation (AF) episodes, in a free-living environment, in participants at risk for having an AF event.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paroxysmal Atrial Fibrillation Patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verily Watch Cardio | Device | The Verily Watch Cardio is an investigational wrist-worn wearable device containing multiple sensors to measure physiological and environmental metrics, including electrodes that enable a single-lead electrocardiogram (ECG) measurement and a photoplethysmogram (PPG) sensor to monitor for irregular pulses. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity of suspected AF episode detection | Sensitivity and Specificity of suspected AF episode detection by the irregular pulse detection algorithm | Up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| A sensitivity analysis estimating the range of sensitivities and specificities | A sensitivity analysis estimating the range of sensitivities and specificities observed when imputing missing test device data | Up to 14 days |
| Sensitivity and Specificity in defined subgroups |
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Inclusion Criteria:
At least 22 years old
Able to read and speak English
Participant understands the study requirements and is able and willing to sign written Informed Consent
At risk of having an AF event, as determined by having a diagnosis of paroxysmal AF (PAF) and meeting one or more of the following:
Without significant limitation in ability to participate in the study, in the opinion of the Investigator
Exclusion Criteria:
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At risk of having an AF event determined by a diagnosis of paroxysmal atrial fibrillation (PAF)
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| Name | Affiliation | Role |
|---|---|---|
| Hamid Ghanbari, MD | Verily Life Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Heart and Vascular | Lakewood | Colorado | 80228 | United States | ||
| Ascension Providence Hospital |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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|
| iRhythm Zio monitor | Device | The iRhythm Zio monitor, the reference device, is an FDA-cleared single-patient use, continuously recording ECG monitor that can be worn for up to 14 days. |
|
| Schiller CARDIOVIT FT-1 | Device | The Schiller CARDIOVIT FT-1, the reference device, is an FDA-cleared portable 12-lead ECG machine capable of recording continuous standard 12-lead resting ECG for up to 4 minutes. |
|
Sensitivity and Specificity in subgroups defined by: race, age-groups, activity level, skin-tone and AF-burden |
| Up to 14 days |
| Mean difference in Interbeat interval (IBI) and the associated limits of agreement (LoA) | Mean difference in Interbeat interval (IBI) and the associated limits of agreement (LoA) based on recorded ECG data | Up to 14 days |
| Participant-level and heartbeat level sensitivity/specificity of P-wave detection | Participant-level and heartbeat level sensitivity/specificity of P-wave detection based on recorded ECG data | Up to 14 days |
| Southfield |
| Michigan |
| 48075 |
| United States |
| Wake Forest Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| D013568 |
| Pathological Conditions, Signs and Symptoms |