Atrial FibrillationFIND-AFNCT05898165
Future Innovations in Novel Detection for Atrial Fibrillation (FIND-AF): Pilot Study
An observational study of Atrial Fibrillation and Heart Diseases, run by University of Leeds at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Atrial Fibrillation, Heart Diseases, Cardiovascular Diseases
- What is being tested?
- Development of an algorithm
- How many people
- 1,955 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2023to 28 Feb 2033
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged >30 will be invited to screening in primary care from information present in their electronic health record (EHR) and their FIND-AF score. They will be given Zenicor ECG devices for up to period of 3 week during which they will be asked to record 4 daily ECG recordings. Those patients who are higher risk for AF based on their FIND-AF score, will be reviewed further for multi-modal phenotyping. Patient with new AF detected will be managed by their primary care clinicians.
Who may be able to join
- Age at enrolment ≥30 years
- Men with CHA2DS2VASC ≥ 2 and women with a CHA2DS2VASC ≥ 3
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Leeds
Leeds, West Yorkshire, LS2 9JT
About this study
Official title: Future Innovations in Novel Detection for Atrial Fibrillation (FIND-AF): Pilot Study of a Risk Score for Early Detection of Atrial Fibrillation
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.
Read the 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.
- Conditions
- Atrial Fibrillation, Heart Diseases, Cardiovascular Diseases
- Being tested
- Development of an algorithm
- Keywords
- Computation, Data Science, Atrial fibrillation, Stroke
- Medical subject headings
- Atrial Fibrillation, Heart Diseases, Cardiovascular Diseases, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Development of an algorithmOther
Prospective verification of a developed algorithm to predict the risk of a new onset Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Measured: 6 months
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
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
Measured: 5 years
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
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
Measured: 10 years
Secondary outcomes (3)
To determine, of participants who are detected as having AF during ECG monitoring, the proportion who subsequently receive oral anticoagulation prescription
Number (%) of participants who receive an oral anticoagulant prescription after diagnoses of AF during ECG monitoring diagnosed
Measured: 6 months
To determine, of participants who are detected as having AF during ECG monitoring, the proportion who subsequently receive oral anticoagulation prescription
Number (%) of participants who receive an oral anticoagulant prescription after diagnoses of AF during ECG monitoring diagnosed
Measured: 5 years
To determine, of participants who are detected as having AF during ECG monitoring, the proportion who subsequently receive oral anticoagulation prescription
Number (%) of participants who receive an oral anticoagulant prescription after diagnoses of AF during ECG monitoring diagnosed
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 Oct 2023
- Primary completion16 Jun 2025
- Study completion28 Feb 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,955 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation, Daiichi Sankyo, The Leeds Teaching Hospitals NHS Trust
- Responsible party
- Principal investigator, Prof Christopher Gale, University of Leeds
- Investigators
- Chris Gale, Yes, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898165
- Sponsor's protocol ID
- 318197_V1.0_230509
- Acronym
- FIND-AF
- Status last verified
- Sep 2026
- First submitted
- 18 May 2023
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared.
Publications
Hamilton E, Shone L, Reynolds C, Wu J, Nadarajah R, Gale C. Perceptions of healthcare professionals on the use of a risk prediction model to inform atrial fibrillation screening: qualitative interview study in English primary care. BMJ Open. 2025 Feb 5;15(2):e091675. doi: 10.1136/bmjopen-2024-091675.
PubMed 39909527Nadarajah R, Wahab A, Reynolds C, Raveendra K, Askham D, Dawson R, Keene J, Shanghavi S, Lip GYH, Hogg D, Cowan C, Wu J, Gale CP. Future Innovations in Novel Detection for Atrial Fibrillation (FIND-AF): pilot study of an electronic health record machine learning algorithm-guided intervention to identify undiagnosed atrial fibrillation. Open Heart. 2023 Sep;10(2):e002447. doi: 10.1136/openhrt-2023-002447.
PubMed 37777255
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Future Innovations in Novel Detection for Atrial Fibrillation (FIND-AF): Pilot Study of a Risk Score for Early Detection of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05898165
- Acronym / sponsor ID
- FIND-AF / 318197_V1.0_230509
- Conditions
- Atrial Fibrillation, Heart Diseases, Cardiovascular Diseases
- Keywords
- Computation, Data Science, Atrial fibrillation, Stroke
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,955 participants (estimated)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- British Heart Foundation, Daiichi Sankyo, The Leeds Teaching Hospitals NHS Trust
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 16 Jun 2025 (actual)
- Study completion
- 28 Feb 2033 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged >30 will be invited to screening in primary care from information present in their electronic health record (EHR) and their FIND-AF score. They will be given Zenicor ECG devices for up to period of 3 week during which they will be asked to record 4 daily ECG recordings. Those patients who are higher risk for AF based on their FIND-AF score, will be reviewed further for multi-modal phenotyping. Patient with new AF detected will be managed by their primary care clinicians.
Key inclusion criteria (2 listed)
- Age at enrolment ≥30 years
- Men with CHA2DS2VASC ≥ 2 and women with a CHA2DS2VASC ≥ 3
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Development of an algorithmProspective verification of a developed algorithm to predict the risk of a new onset Atrial Fibrillation | Other | – |
Primary outcome
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
Time frame: 6 months
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
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
Time frame: 5 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
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
Time frame: 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
3 secondary outcomes
To determine, of participants who are detected as having AF during ECG monitoring, the proportion who subsequently receive oral anticoagulation prescription
Time frame: 6 months
To determine, of participants who are detected as having AF during ECG monitoring, the proportion who subsequently receive oral anticoagulation prescription
Time frame: 5 years
To determine, of participants who are detected as having AF during ECG monitoring, the proportion who subsequently receive oral anticoagulation prescription
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Derived from this study: PubMed 39909527Hamilton E, Shone L, Reynolds C, Wu J, Nadarajah R, Gale C. Perceptions of healthcare professionals on the use of a risk prediction model to inform atrial fibrillation screening: qualitative interview study in English primary care. BMJ Open. 2025 Feb 5;15(2):e091675. doi: 10.1136/bmjopen-2024-091675.
- Derived from this study: PubMed 37777255Nadarajah R, Wahab A, Reynolds C, Raveendra K, Askham D, Dawson R, Keene J, Shanghavi S, Lip GYH, Hogg D, Cowan C, Wu J, Gale CP. Future Innovations in Novel Detection for Atrial Fibrillation (FIND-AF): pilot study of an electronic health record machine learning algorithm-guided intervention to identify undiagnosed atrial fibrillation. Open Heart. 2023 Sep;10(2):e002447. doi: 10.1136/openhrt-2023-002447.
- Individual participant dataSharing planned: No. No individual participant data will be shared.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Gale, Yes principal investigator
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Heart Diseases, run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05898165, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.