Clinical trial NCT04546763: Study Watch AF Detection At Home
Official title: Study Watch AF Detection At Home
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Verily Life Sciences LLC
Sponsor class: INDUSTRY
First posted: 2020-09-14
Enrollment: 117
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: At risk of having an AF event, as determined by having a diagnosis of paroxysmal AF (PAF)

Brief summary: This is a multi-center, prospective, non-randomized study to evaluate the performance of the study watch PPG algorithm in detecting irregular rhythms suggestive of atrial fibrillation (AF) in subjects at risk of having an event of AF in the free living (home) environment.


Eligibility criteria: Inclusion Criteria:

* At least 22 years old
* Able to read and speak English
* Able and willing to sign written Informed Consent
* Interest in participating in the study
* At risk of having an AF event, as determined by having a diagnosis of paroxysmal AF (PAF) and meeting one of the following: (a) scheduled or to be scheduled to undergo AF ablation, (b) with implantable loop recorder (ILR), implantable cardioverter defibrillator (ICD), permanent pacemaker (PPM), holter monitor, or adhesive monitoring patch with documented AF burden of ≥25% in the 3 months prior to consent date, (c) CHA2DS2VASc ≥3, (d) Left atrial diameter ≥4.4 cm
* Without significant limitation in ability to participate in the study, in the opinion of the investigator

Exclusion Criteria:

* Currently in a paced rhythm
* 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)
* 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 adhesives or hydrogels or with family history of adhesive skin allergies
* Are diagnosed with persistent AF
* Use of implantable neuro-stimulator
* Open injury or rash where the study device or comparator will be worn

Primary outcomes:
measure: Accuracy of AF detection - Sensitivity
timeFrame: 14 days
measure: Accuracy of AF detection - Specificity
timeFrame: 14 days
Secondary outcomes:
measure: A sensitivity analysis estimating the range of sensitivities
timeFrame: 14 days
measure: A sensitivity analysis estimating the range of specificities
timeFrame: 14 days
measure: Estimates of sensitivity by protocol-defined subgroups
timeFrame: 14 days
measure: Estimates of specificity in subgroups
timeFrame: 14 days
measure: Estimates of positive predictive value (PPV) on the AF-burden
timeFrame: 14 days
measure: Estimates of negative predictive value (NPV) on the AF-burden
timeFrame: 14 days
measure: Estimates of PPV on the AF burden to a screening population
timeFrame: 14 days
measure: Estimates of NPV on the AF burden to a screening population
timeFrame: 14 days
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego Cardiac Center
state: California
city: Lakewood
country: United States
facility: Colorado Heart and Vascular
state: Colorado
city: Southfield
country: United States
facility: Ascension Providence Hospital
state: Michigan
city: Harrisburg
country: United States
facility: UPMC Pinnacle Harrisburg
state: Pennsylvania
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: Verily Life Sciences
name: Hamid Ghanbari
role: PRINCIPAL_INVESTIGATOR
References: