Verily Watch Cardio (AF and ECG) Study

Withdrawn before enrolling

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT06041373

Run by

Verily Life Sciences LLC

People needed

0

Starts

2023-11-01

Expected to finish

2024-11-01

Last updated by the study team

2023-12-22

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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