Future Innovations in Novel Detection for Atrial Fibrillation (FIND-AF): Pilot Study

Active, not recruiting

• Conditions: Heart Diseases; Atrial Fibrillation; Cardiovascular Diseases

• Registration Number: NCT05898165
• Lead Sponsor: University of Leeds

Brief Summary

The purpose of this study is to trial a new intervention - risk-guided AF screening using an EHR-based risk score and remote ECG monitoring process - and to characterise individuals at elevated predicted AF risk.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-05-18
• Study First Submitted QC: 2023-05-31
• Study First Posted: 2023-06-12
• Study Start: 2023-10-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2025-06
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1955

Inclusion Criteria

• Age at enrolment ≥30 years
• Men with CHA2DS2VASC ≥ 2 and women with a CHA2DS2VASC ≥ 3

Exclusion Criteria

• Known diagnosis of AF
• On anticoagulation therapy
• On the palliative care register
• Unable to give written informed consent for participation in the study
• Unable to adhere to the study requirements

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine whether detection rates of AF during ECG monitoring are higher amongst participants identified as higher risk of AF, compared with those identified as lower risk	10 years	Rate ratio of AF detection rates during ECG monitoring in participants identified as higher risk by FIND-AF compared with participants identified as lower risk

Secondary Outcome Measures

Name	Time	Method
To determine, of participants who are detected as having AF during ECG monitoring, the proportion who subsequently receive oral anticoagulation prescription	10 years	Number (%) of participants who receive an oral anticoagulant prescription after diagnoses of AF during ECG monitoring diagnosed

Trial Locations

Locations (1)

University of Leeds; 🇬🇧 Leeds, West Yorkshire, United Kingdom