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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04546763
Other study ID # 102238
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 3, 2020
Est. completion date May 14, 2021

Study information

Verified date October 2021
Source Verily Life Sciences LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 117
Est. completion date May 14, 2021
Est. primary completion date May 14, 2021
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Study Watch
The Study Watch is a miniaturized wearable device made with biocompatible contact materials containing various sensors capable of measuring physiological and environmental metrics.
Zio XT
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.

Locations

Country Name City State
United States UT Southwestern Medical Center Dallas Texas
United States UPMC Pinnacle Harrisburg Harrisburg Pennsylvania
United States Colorado Heart and Vascular Lakewood Colorado
United States San Diego Cardiac Center San Diego California
United States Ascension Providence Hospital Southfield Michigan

Sponsors (1)

Lead Sponsor Collaborator
Verily Life Sciences LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Accuracy of AF detection - Sensitivity Accuracy of AF detection based on sensitivity observed in a 14-day followup period 14 days
Primary Accuracy of AF detection - Specificity Accuracy of AF detection based on specificity observed in a 14-day followup period 14 days
Secondary A sensitivity analysis estimating the range of sensitivities A sensitivity analysis estimating the range of sensitivities when imputing insufficient quality data 14 days
Secondary A sensitivity analysis estimating the range of specificities A sensitivity analysis estimating the range of specificities when imputing insufficient quality data 14 days
Secondary Estimates of sensitivity by protocol-defined subgroups Estimates of sensitivity by protocol-defined subgroups 14 days
Secondary Estimates of specificity in subgroups Estimates of specificity in subgroups defined by: race, age-groups, site, activity levels, and AF-burden 14 days
Secondary Estimates of positive predictive value (PPV) on the AF-burden Estimates of PPV based on the AF-burden observed in the study 14 days
Secondary Estimates of negative predictive value (NPV) on the AF-burden Estimates of NPV based on the AF-burden observed in the study 14 days
Secondary 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
Secondary 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
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