Verily Watch Cardio (AF and ECG) Study

Verily Life Sciences

Status: Withdrawn

Conditions: Atrial Fibrillation

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

Study type: Observational

Funder types: Industry

Identifiers

NCT06041373

104343

Details and patient eligibility

About

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.

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

0 participants in 1 patient group

Paroxysmal Atrial Fibrillation Patients

Treatment:

Device: iRhythm Zio monitor

Device: Schiller CARDIOVIT FT-1

Device: Verily Watch Cardio