Study Watch AF Detection At Home

Study Overview
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Brief Summary
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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.

Official Title
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Study Watch AF Detection At Home

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Study Watch
* Device: Zio XT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 22 years old Able to read and speak English Able and willing to sign written Informed Consent Interest in participating in the study At risk of having an AF event, as determined by having a diagnosis of paroxysmal AF (PAF) and meeting one of the following: (a) scheduled or to be scheduled to undergo AF ablation, (b) with implantable loop recorder (ILR), implantable cardioverter defibrillator (ICD), permanent pacemaker (PPM), holter monitor, or adhesive monitoring patch with documented AF burden of ≥25% in the 3 months prior to consent date, (c) CHA2DS2VASc ≥3, (d) Left atrial diameter ≥4.4 cm Without significant limitation in ability to participate in the study, in the opinion of the investigator Exclusion Criteria: Currently in a paced rhythm Currently on class Ic or class III antiarrhythmic medication that has been successful in eliminating AF (no documented AF of more than 30 seconds since the initiation of the medication) Had successful AF ablation (no documented AF of more than 30 seconds post procedure) Known severe allergy to nickel or metal jewelry Known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies Are diagnosed with persistent AF Use of implantable neuro-stimulator Open injury or rash where the study device or comparator will be worn

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Paroxysmal Atrial Fibrillation Patients<br>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. | Device: Study Watch<br>* The Study Watch is a miniaturized wearable device made with biocompatible contact materials containing various sensors capable of measuring physiological and environmental metrics.<br>Device: Zio XT<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |