Verily Watch Cardio (AF and ECG) Study
- Conditions
- Atrial Fibrillation
- Interventions
- Device: Verily Watch CardioDevice: iRhythm Zio monitorDevice: Schiller CARDIOVIT FT-1
- Registration Number
- NCT06041373
- Lead Sponsor
- Verily Life Sciences LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
-
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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Paroxysmal Atrial Fibrillation Patients Verily Watch Cardio - Paroxysmal Atrial Fibrillation Patients Schiller CARDIOVIT FT-1 - Paroxysmal Atrial Fibrillation Patients iRhythm Zio monitor -
- Primary Outcome Measures
Name Time Method Sensitivity and Specificity of suspected AF episode detection Up to 14 days Sensitivity and Specificity of suspected AF episode detection by the irregular pulse detection algorithm
- Secondary Outcome Measures
Name Time Method Mean difference in Interbeat interval (IBI) and the associated limits of agreement (LoA) Up to 14 days Mean difference in Interbeat interval (IBI) and the associated limits of agreement (LoA) based on recorded ECG data
Participant-level and heartbeat level sensitivity/specificity of P-wave detection Up to 14 days Participant-level and heartbeat level sensitivity/specificity of P-wave detection based on recorded ECG data
A sensitivity analysis estimating the range of sensitivities and specificities Up to 14 days A sensitivity analysis estimating the range of sensitivities and specificities observed when imputing missing test device data
Sensitivity and Specificity in defined subgroups Up to 14 days Sensitivity and Specificity in subgroups defined by: race, age-groups, activity level, skin-tone and AF-burden
Trial Locations
- Locations (3)
Wake Forest Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Colorado Heart and Vascular
🇺🇸Lakewood, Colorado, United States
Ascension Providence Hospital
🇺🇸Southfield, Michigan, United States