Verily Watch Cardio (AF and ECG) Study

This study is designed to evaluate the performance of the Verily Watch Cardio for recording electrocardiogram (ECG) and photoplethysmography (PPG) signals and detecting suspected atrial fibrillation (AF) episodes, in a free-living environment, in participants at risk for having an AF event.

Study Overview

• Status: Withdrawn
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Verily Watch Cardio; Device: iRhythm Zio monitor; Device: Schiller CARDIOVIT FT-1

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • Colorado Heart and Vascular
  • Michigan
    • Southfield, Michigan, United States, 48075
      • Ascension Providence Hospital
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

At risk of having an AF event determined by a diagnosis of paroxysmal atrial fibrillation (PAF)

Description

Inclusion Criteria:

• At least 22 years old
• Able to read and speak English
• Participant understands the study requirements and is able and willing to sign written Informed Consent

• At risk of having an AF event, as determined by having a diagnosis of paroxysmal AF (PAF) and meeting one or more of the following:

  1. Scheduled or to be scheduled to undergo AF ablation
  2. AF burden of ≥25% in the 3 months prior to consent date as confirmed via an implantable loop recorder (ILR), holter monitor, or adhesive monitoring patch
  3. CHA2DS2VASc score ≥3
  4. Left atrial diameter ≥4.4 cm as confirmed by transthoracic echo (TTE) within one year of consent
• Without significant limitation in ability to participate in the study, in the opinion of the Investigator

Exclusion Criteria:

• Have a pacemaker or implantable cardioverter defibrillator (ICD)
• 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). Should be at least one week off 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 polyester, nylon, spandex, adhesives or hydrogels; or with family history of adhesive skin allergies
• Are diagnosed with persistent AF
• Have an implantable neuro-stimulator
• Currently wearing an ECG patch that prevents the use of the FDA-cleared wearable ECG patch, at the discretion of the Investigator.
• Have discolored wrists (e.g., tattoos, ink), at the discretion of the Investigator.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Paroxysmal Atrial Fibrillation Patients

Device: Verily Watch Cardio; The Verily Watch Cardio is an investigational wrist-worn wearable device containing multiple sensors to measure physiological and environmental metrics, including electrodes that enable a single-lead electrocardiogram (ECG) measurement and a photoplethysmogram (PPG) sensor to monitor for irregular pulses.; Device: iRhythm Zio monitor; The iRhythm Zio monitor, the reference device, is an FDA-cleared single-patient use, continuously recording ECG monitor that can be worn for up to 14 days.; Device: Schiller CARDIOVIT FT-1; The Schiller CARDIOVIT FT-1, the reference device, is an FDA-cleared portable 12-lead ECG machine capable of recording continuous standard 12-lead resting ECG for up to 4 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and Specificity of suspected AF episode detection	Sensitivity and Specificity of suspected AF episode detection by the irregular pulse detection algorithm	Up to 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A sensitivity analysis estimating the range of sensitivities and specificities	A sensitivity analysis estimating the range of sensitivities and specificities observed when imputing missing test device data	Up to 14 days
Sensitivity and Specificity in defined subgroups	Sensitivity and Specificity in subgroups defined by: race, age-groups, activity level, skin-tone and AF-burden	Up to 14 days
Mean difference in Interbeat interval (IBI) and the associated limits of agreement (LoA)	Mean difference in Interbeat interval (IBI) and the associated limits of agreement (LoA) based on recorded ECG data	Up to 14 days
Participant-level and heartbeat level sensitivity/specificity of P-wave detection	Participant-level and heartbeat level sensitivity/specificity of P-wave detection based on recorded ECG data	Up to 14 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: September 11, 2023
• First Submitted That Met QC Criteria: September 11, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

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: 104343

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