Study Watch
DeviceThe Study Watch is a miniaturized wearable device made with biocompatible contact materials containing various sensors capable of measuring physiological and environmental metrics.
NCT Number: NCT04546763
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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Notify Me22 year and older
All sexes
Observational
San Diego Cardiac Center, San Diego, California, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The Study Watch is a miniaturized wearable device made with biocompatible contact materials containing various sensors capable of measuring physiological and environmental metrics.
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.
Time frame: 14 days
Accuracy of AF detection based on sensitivity observed in a 14-day followup period
Time frame: 14 days
Accuracy of AF detection based on specificity observed in a 14-day followup period
Time frame: 14 days
A sensitivity analysis estimating the range of sensitivities when imputing insufficient quality data
Time frame: 14 days
A sensitivity analysis estimating the range of specificities when imputing insufficient quality data
Time frame: 14 days
Estimates of sensitivity by protocol-defined subgroups
Time frame: 14 days
Estimates of specificity in subgroups defined by: race, age-groups, site, activity levels, and AF-burden
Time frame: 14 days
Estimates of PPV based on the AF-burden observed in the study
Time frame: 14 days
Estimates of NPV based on the AF-burden observed in the study
Time frame: 14 days
Estimates of PPV based on the AF burden relevant to a screening population
Time frame: 14 days
Estimates of NPV based on the AF burden relevant to a screening population
Verily Life Sciences LLC
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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