Study Watch AF Detection At Home

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: Study Watch; Device: Zio XT

• Registration Number: NCT04546763
• Lead Sponsor: Verily Life Sciences LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-03
• Study First Submitted: 2020-09-04
• Study First Submitted QC: 2020-09-04
• Study First Posted: 2020-09-14
• Primary Completion: 2021-05-14
• Study Completion: 2021-05-14
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-05
• Last Update Posted: 2021-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Paroxysmal Atrial Fibrillation Patients	Study Watch	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.
Paroxysmal Atrial Fibrillation Patients	Zio XT	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.

Primary Outcome Measures

Name	Time	Method
Accuracy of AF detection - Sensitivity	14 days	Accuracy of AF detection based on sensitivity observed in a 14-day followup period
Accuracy of AF detection - Specificity	14 days	Accuracy of AF detection based on specificity observed in a 14-day followup period

Secondary Outcome Measures

Name	Time	Method
Estimates of sensitivity by protocol-defined subgroups	14 days	Estimates of sensitivity by protocol-defined subgroups
Estimates of PPV on the AF burden to a screening population	14 days	Estimates of PPV based on the AF burden relevant to a screening population
Estimates of NPV on the AF burden to a screening population	14 days	Estimates of NPV based on the AF burden relevant to a screening population
Estimates of specificity in subgroups	14 days	Estimates of specificity in subgroups defined by: race, age-groups, site, activity levels, and AF-burden
A sensitivity analysis estimating the range of sensitivities	14 days	A sensitivity analysis estimating the range of sensitivities when imputing insufficient quality data
A sensitivity analysis estimating the range of specificities	14 days	A sensitivity analysis estimating the range of specificities when imputing insufficient quality data
Estimates of negative predictive value (NPV) on the AF-burden	14 days	Estimates of NPV based on the AF-burden observed in the study
Estimates of positive predictive value (PPV) on the AF-burden	14 days	Estimates of PPV based on the AF-burden observed in the study

Trial Locations

Locations (5)

San Diego Cardiac Center; 🇺🇸 San Diego, California, United States

Ascension Providence Hospital; 🇺🇸 Southfield, Michigan, United States

Colorado Heart and Vascular; 🇺🇸 Lakewood, Colorado, United States

UPMC Pinnacle Harrisburg; 🇺🇸 Harrisburg, Pennsylvania, United States

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States