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This is a multi-center, prospective, non-randomized study to evaluate the performance of the study watch PPG algorithm in detecting irregular rhythms suggestive of atrial fibrillation (AF) in subjects at risk of having an event of AF in the free living (home) environment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paroxysmal Atrial Fibrillation Patients | This will be a single arm study of patients with paroxysmal atrial fibrillation. Subjects will be wearing the Study Watch and Zio XT Patch concurrently for up to 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study Watch | Device | The Study Watch is a miniaturized wearable device made with biocompatible contact materials containing various sensors capable of measuring physiological and environmental metrics. |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of AF detection - Sensitivity | Accuracy of AF detection based on sensitivity observed in a 14-day followup period | 14 days |
| Accuracy of AF detection - Specificity | Accuracy of AF detection based on specificity observed in a 14-day followup period | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| A sensitivity analysis estimating the range of sensitivities | A sensitivity analysis estimating the range of sensitivities when imputing insufficient quality data | 14 days |
| A sensitivity analysis estimating the range of specificities |
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Inclusion Criteria:
Exclusion Criteria:
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At risk of having an AF event, as determined by having a diagnosis of paroxysmal AF (PAF)
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| Name | Affiliation | Role |
|---|---|---|
| Hamid Ghanbari | Verily Life Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego Cardiac Center | San Diego | California | 92123 | United States | ||
| Colorado Heart and Vascular |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37750558 | Derived | Poh MZ, Battisti AJ, Cheng LF, Lin J, Patwardhan A, Venkataraman GS, Athill CA, Patel NS, Patel CP, Machado CE, Ellis JT, Crosson LA, Tamura Y, Plowman RS, Turakhia MP, Ghanbari H. Validation of a Deep Learning Algorithm for Continuous, Real-Time Detection of Atrial Fibrillation Using a Wrist-Worn Device in an Ambulatory Environment. J Am Heart Assoc. 2023 Oct 3;12(19):e030543. doi: 10.1161/JAHA.123.030543. Epub 2023 Sep 26. |
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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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| Zio XT | Device | The Zio XT Patch, the reference device, is a FDA-cleared single-patient use, continuously recording ECG monitor that can be worn up to 14 days. |
|
A sensitivity analysis estimating the range of specificities when imputing insufficient quality data
| 14 days |
| Estimates of sensitivity by protocol-defined subgroups | Estimates of sensitivity by protocol-defined subgroups | 14 days |
| Estimates of specificity in subgroups | Estimates of specificity in subgroups defined by: race, age-groups, site, activity levels, and AF-burden | 14 days |
| Estimates of positive predictive value (PPV) on the AF-burden | Estimates of PPV based on the AF-burden observed in the study | 14 days |
| Estimates of negative predictive value (NPV) on the AF-burden | Estimates of NPV based on the AF-burden observed in the study | 14 days |
| Estimates of PPV on the AF burden to a screening population | Estimates of PPV based on the AF burden relevant to a screening population | 14 days |
| Estimates of NPV on the AF burden to a screening population | Estimates of NPV based on the AF burden relevant to a screening population | 14 days |
| Lakewood |
| Colorado |
| 80228 |
| United States |
| Ascension Providence Hospital | Southfield | Michigan | 48075 | United States |
| UPMC Pinnacle Harrisburg | Harrisburg | Pennsylvania | 17011 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| D013568 |
| Pathological Conditions, Signs and Symptoms |