Status:
WITHDRAWN
Verily Watch Cardio (AF and ECG) Study
Lead Sponsor:
Verily Life Sciences LLC
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
22+ years
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 (...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06041373
Start Date
November 1 2023
End Date
November 1 2024
Last Update
December 22 2023
Active Locations (3)
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1
Colorado Heart and Vascular
Lakewood, Colorado, United States, 80228
2
Ascension Providence Hospital
Southfield, Michigan, United States, 48075
3
Wake Forest Medical Center
Winston-Salem, North Carolina, United States, 27157