This pilot study will use a post-market device within its intended purpose and involve a
change in standard care - that is the offer of ECG monitoring for individuals at risk of
AF to understand whether this leads to an increase in detection rates of AF, and
follow-through prescription of oral anticoagulation.
Starting with the population that are eligible for oral anticoagulation (men with a
CHA2DS2VASC ≥ 2 and women with a CHA2DS2VASC ≥ 3), but without AF, this pilot study will
use FIND-AF within its intended purpose to predict the absolute risk of AF diagnosis for
individuals within the next 6 months. It will be observed whether systematic AF screening
leads to higher detection rates of AF in individuals at higher risk for AF than
individuals at lower risk for AF.
This will give pilot data for whether systematic screening for AF in individuals at
higher AF risk results in an incrementally higher yield of AF detection compared with
screening approaches that have been targeted by age and risk of AF-related stroke. If the
pilot shows that detection rates for AF are higher in the group at higher AF risk, then
it would be suitable to plan a randomised controlled trial to determine whether
systematic AF screening guided by AF risk increases detection rates of AF compared with
routine care, and whether this is associated with a lower rate of stroke. The detection
rates during systematic AF screening in this pilot study for individuals at higher and
lower risk can establish power calculations required for a full-scale study and whether
the numeric score at which a clinician would implement the intervention can be optimised.
In addition, this pilot study will establish the technical, logistic and administrative
feasibility of a full-scale remote AF screening study including issues of recruitment and
protocol adherence. It will also inform as to whether individuals diagnosed with AF by
systematic AF screening in the community will receive oral anticoagulation interventions
in primary care, and thus whether treatment of screen-detected AF in a full-scale study
should be implemented in primary care or in secondary care under cardiology.
Finally this study will offer participants at higher AF risk the opportunity to attend a
research clinic to determine whether these individuals have risk factors and
comorbidities that could be identified and treated to reduce their subsequent risk of AF
and other adverse events. This will establish whether individuals at risk of AF will
attend for review, and their burden of modifiable risk factors for AF. This will
establish power calculations that would be required for a full-scale study to test the
hypothesis that primary prevention of AF is possible through interventions aimed at
individuals at risk of AF.
