Study Watch AF Detection At Home

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Study Watch; Device: Zio XT

• Study Type: Observational
• Enrollment (Actual): 117

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • San Diego Cardiac Center
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • Colorado Heart and Vascular
  • Michigan
    • Southfield, Michigan, United States, 48075
      • Ascension Providence Hospital
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17011
      • UPMC Pinnacle Harrisburg
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

At risk of having an AF event, as determined by having a diagnosis of paroxysmal AF (PAF)

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.; Device: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Verily Life Sciences LLC
• Investigators: Principal Investigator: Hamid Ghanbari, Verily Life Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2020
• Primary Completion (Actual): May 14, 2021
• Study Completion (Actual): May 14, 2021

Study Registration Dates

• First Submitted: September 4, 2020
• First Submitted That Met QC Criteria: September 4, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 102238

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No