Verily Watch Cardio (AF and ECG) Study

NCT06041373 | Withdrawn FDA Device

• 1 other identifier: 104343
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• A sensitivity analysis estimating the range of sensitivities and specificities

  Up to 14 days

• Sensitivity and Specificity in defined subgroups

  Up to 14 days

• Mean difference in Interbeat interval (IBI) and the associated limits of agreement (LoA)

  Up to 14 days

• Participant-level and heartbeat level sensitivity/specificity of P-wave detection

  Up to 14 days

Study Arms (1)

Paroxysmal Atrial Fibrillation Patients

Device: Verily Watch Cardio; Device: iRhythm Zio monitor; Device: Schiller CARDIOVIT FT-1

Interventions

Verily Watch Cardio DEVICE

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.

Paroxysmal Atrial Fibrillation Patients

iRhythm Zio monitor DEVICE

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.

Paroxysmal Atrial Fibrillation Patients

Schiller CARDIOVIT FT-1 DEVICE

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.

Paroxysmal Atrial Fibrillation Patients

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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:
• Scheduled or to be scheduled to undergo AF ablation
• 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
• CHA2DS2VASc score ≥3
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Verily Life Sciences LLC: lead

Study Sites (3)

Colorado Heart and Vascular

Lakewood, Colorado, 80228, United States

Location

Ascension Providence Hospital

Southfield, Michigan, 48075, United States

Location

Wake Forest Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hamid Ghanbari, MD

  Verily Life Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 18, 2023
• Study Start: November 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: November 1, 2024
• Last Updated: December 22, 2023

Record last verified: 2023-12

Locations

US (3)