Clinical trial NCT06041373: Verily Watch Cardio (AF and ECG) Study
Official title: Verily Watch Cardio (AF and ECG) Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Atrial Fibrillation
Lead sponsor: Verily Life Sciences LLC
Sponsor class: INDUSTRY
First posted: 2023-09-18
Enrollment: 0
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: At risk of having an AF event determined by a diagnosis of paroxysmal atrial fibrillation (PAF)

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity and Specificity of suspected AF episode detection
timeFrame: Up to 14 days
Secondary outcomes:
measure: A sensitivity analysis estimating the range of sensitivities and specificities
timeFrame: Up to 14 days
measure: Sensitivity and Specificity in defined subgroups
timeFrame: Up to 14 days
measure: Mean difference in Interbeat interval (IBI) and the associated limits of agreement (LoA)
timeFrame: Up to 14 days
measure: Participant-level and heartbeat level sensitivity/specificity of P-wave detection
timeFrame: Up to 14 days
Other outcomes:
Locations:
city: Lakewood
country: United States
facility: Colorado Heart and Vascular
state: Colorado
city: Southfield
country: United States
facility: Ascension Providence Hospital
state: Michigan
city: Winston-Salem
country: United States
facility: Wake Forest Medical Center
state: North Carolina
Study officials:
affiliation: Verily Life Sciences
name: Hamid Ghanbari, MD
role: PRINCIPAL_INVESTIGATOR
References: