Atrial Fibrillation and FlutterR-BEATNCT03911986
Risk-Based Screening for the Evaluation of Atrial Fibrillation Trial
A study testing R Test 4 External Loop Recorder in people with Atrial Fibrillation and Flutter, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.
Trial summary
1. To determine whether a risk-based screening programme for occult paroxysmal atrial fibrillation, involving extended cardiac monitoring in adults with CHA2DS2-VASc score of 3 or greater, increases the detection of new atrial fibrillation/flutter. 2. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Atrial Fibrillation and Flutter
- What is being tested?
- R Test 4 External Loop Recorder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 755 participants
- Where
- 1 siteIreland
- Study dates
- 21 Mar 2018to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed a study specific Informed Consent Form
- 55 years of age or older
- Attending one of the participating General Practices in the R-BEAT Trial
- Attended at least one GP appointment within the past 12 months
- CHA2DS2-VASc Score >2
Who cannot join
- Contraindication to oral anticoagulant therapy
- History of intracerebral haemorrhage
- Prior intolerance or refusal of oral anticoagulant therapy
- (If intolerant or refused warfarin, may be included if considered suitable for non vitamin-K oral anticoagulant, NOAC)
- Gastrointestinal haemorrhage of unexplained or unmodifiable aetiology (i.e. risk of haemorrhage has not been reduced)
- Other major bleed that would exclude oral anticoagulant therapy
Show all 12Show fewer
- Known Atrial fibrillation/flutter
- Currently prescribed oral anticoagulant therapy
- Unsuitable for anticoagulant therapy, in opinion of attending general practitioner
- Unsuitable for cardiac monitoring, in opinion of attending general practitioner
- Allergies to plasters or adhesives
- Has had cardiac monitoring for >48 hours within the last 12 months, has an implantable loop recorder, or scheduled to have cardiac monitoring/ILR.
Trial locations and contacts
1 site in 1 country.
Ireland1 site
HRB Clinical Research Facility Galway
Galway, County Galway, H91 YR71
About this study
Official title: Risk-Based Screening for the Evaluation of Atrial Fibrillation Trial (R-BEAT)
- To determine whether a risk-based screening programme for occult paroxysmal atrial fibrillation, involving extended cardiac monitoring in adults with CHA2DS2-VASc score of 3 or greater, increases the detection of new atrial fibrillation/flutter.
- To determine whether a risk-based screening programme for occult paroxysmal atrial fibrillation, involving extended cardiac monitoring in adults with CHA2DS2-VASc score of 3 or greater, is cost-effective.
- To determine the sensitivity, specificity, positive predictive value and negative predictive values of self-monitoring of pulse in adults for detection of atrial fibrillation.
- To determine the cost, cost effectiveness, and budget impact of a risk-based screening programme for occult paroxysmal atrial fibrillation, relative to a control of usual care in general practice.
Read the detailed description
Stroke is a leading cause of death and disability. A first diagnosis of atrial fibrillation may occur at the time of stroke (e.g. about 45% of patients with acute stroke). Undiagnosed atrial fibrillation is therefore a major care-gap in stroke prevention.
Against this backdrop, oral anticoagulant therapy is extremely effective at reducing the risk of ischemic stroke in atrial fibrillation, associated with a two-thirds risk reduction. Therefore, a major care gap in stroke prevention is the prevalence of undetected atrial fibrillation in the community. Traditional pulse screening in all patients > 65 years detects new atrial fibrillation in about 1% of people.
The CHA2DS2-VASc score was developed and validated to risk-stratify patients with atrial fibrillation into low, intermediate and high risk of stroke. The Investigators believe that the CHA2DS2-VASc score represents an opportunity to identify patients at high risk of atrial fibrillation, but also identifies this at highest risk of stroke, and therefore those that will derive greatest benefit from anticoagulant therapy.
The advent of external-worn event loop recorders (ELRs) present a more convenient and efficient method of detecting atrial fibrillation. Loop recorders have an in-built diagnostic algorithm that identifies atrial fibrillation, and initiates recordings before and after the event-trigger. This rhythm strip is then examined and confirmed by the trial cardiac technician. The investigators will examine if using external loop recorders in patients identified as high risk will improve the detection rate of paroxysmal atrial fibrillation.
The study is a randomised controlled cross-over multi-centered clinical trial in General Practice. Ethical approval has been sought from the Galway University Hospitals research ethics committee. The investigators have also engaged with Clinical Research Patient and Public Involvement.
The investigators primary research question is whether extended cardiac rhythm monitoring (with ELR for 1 week), compared to standard care, in patients pre-identified to be at high-risk of atrial fibrillation (defined by CHA2DS2-VASc score >2) increases the detection of new atrial fibrillation resulting in introduction of oral anticoagulant therapy, that is efficient, acceptable to patients and cost-effective.
All participating general practices will require the Socrates software package. The investigators will run analyses to identify patients with a CHA2DS2-VASc of 3 or greater. The investigators will exclude all patients with known atrial fibrillation, those in whom contraindications to oral anticoagulant therapy exist, and those who are deemed unsuitable for extended monitoring.
- Conditions
- Atrial Fibrillation and Flutter
- Being tested
- R Test 4 External Loop Recorder
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R Test 4 External Loop RecorderDevice
The R-Test 4 is an externally worn, re-usable, battery-powered, lightweight ECG monitor, which records events triggered by cardiac arrhythmias. It is worn for 7 days. Cardiac monitoring is triggered by tachycardia or detection of irregular pulses or patient may trigger recording, if the participant experience symptoms (e.g. palpitations). The patient wears 2 chest leads (on one, the R-Test device is attached, weight 42g). The R-Test 4 is CE marked, and uses an FDA-approved algorithm for automatic detection of atrial fibrillation, and permits 5 minutes of pre-event recording and 5 minutes of post-event recording.
| Study group | Role | What they receive |
|---|---|---|
| Immediate External Loop Recorder | Other | Participants randomized to the Immediate External Loop Recorder group will be monitored for the duration of the first week of the study using the Novacor R-Test 4. Receives: Device: R Test 4 External Loop Recorder |
| Delayed External Loop Recorder | Other | Participants randomized to the Delayed External Loop Recorder group will be monitored for the duration of the second week of the study using the Novacor R-Test 4. Receives: Device: R Test 4 External Loop Recorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
New detected (and centrally confirmed) cases of atrial fibrillation/flutter > 2 minutes
New detected (and centrally confirmed) cases of atrial fibrillation/flutter > 2 minutes in duration using a built in diagnostic algorithm that identifies probable atrial fibrillation. The identified instances will be reviewed by a cardiologist for confirmation of atrial fibrillation/atrial flutter
Measured: 2 years
Secondary outcomes (1)
Initiation of oral anticoagulation
prescription
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start21 Mar 2018
- Primary completion30 Jun 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation and FlutterStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A randomized controlled cross-over multi-centered clinical trial in General Practice, comparing; a) opportunistic pulse screening + immediate ELR device (R-Test) for 1 week; or, b) opportunistic pulse screening + delayed ELR device (R-Test) for 1 week, in patients with CHA2DS2-VASc score of 3 or greater, and without a contraindication to oral anticoagulation.
- Masking
- None (open label)
- Enrolment
- 755 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Ireland, Galway, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- Health Research Board, Ireland
- Responsible party
- Principal investigator, Ruairi Waters, National University of Ireland, Galway, Ireland
- Investigators
- Colin Hardy, BSc, Study chair, Project Officer and Site Management Coordinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03911986
- Sponsor's protocol ID
- 17-CRFG 17
- Acronym
- R-BEAT
- Status last verified
- Feb 2024
- First submitted
- 21 Mar 2018
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Murphy R, Waters R, Murphy A, McDermott S, Reddin C, Hernon O, Davies N, Alvarez-Iglesias A, Twomey E, O'Shea E, Sloane P, Curran J, Kiely A, Waters C, Kilraine J, McDonagh S, Carney A, Devane D, O'Donnell M. Risk-based screening for the evaluation of atrial fibrillation in general practice (R-BEAT): a randomized cross-over trial. QJM. 2025 Mar 1;118(3):166-173. doi: 10.1093/qjmed/hcaf001.
PubMed 39786890
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk-Based Screening for the Evaluation of Atrial Fibrillation Trial (R-BEAT)
- ClinicalTrials.gov ID
- NCT03911986
- Acronym / sponsor ID
- R-BEAT / 17-CRFG 17
- Conditions
- Atrial Fibrillation and Flutter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 755 participants (actual)
- Lead sponsor
- National University of Ireland, Galway, IrelandUniversity, hospital or other
- Collaborators
- Health Research Board, Ireland
- Study start
- 21 Mar 2018 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 11 Apr 2019 (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.
- To determine whether a risk-based screening programme for occult paroxysmal atrial fibrillation, involving extended cardiac monitoring in adults with CHA2DS2-VASc score of 3 or greater, increases the detection of new atrial fibrillation/flutter.
- To determine whether a risk-based screening programme for occult paroxysmal atrial fibrillation, involving extended cardiac monitoring in adults with CHA2DS2-VASc score of 3 or greater, is cost-effective.
- To determine the sensitivity, specificity, positive predictive value and negative predictive values of self-monitoring of pulse in adults for detection of atrial fibrillation.
- To determine the cost, cost effectiveness, and budget impact of a risk-based screening programme for occult paroxysmal atrial fibrillation, relative to a control of usual care in general practice.
Detailed description
Stroke is a leading cause of death and disability. A first diagnosis of atrial fibrillation may occur at the time of stroke (e.g. about 45% of patients with acute stroke). Undiagnosed atrial fibrillation is therefore a major care-gap in stroke prevention.
Against this backdrop, oral anticoagulant therapy is extremely effective at reducing the risk of ischemic stroke in atrial fibrillation, associated with a two-thirds risk reduction. Therefore, a major care gap in stroke prevention is the prevalence of undetected atrial fibrillation in the community. Traditional pulse screening in all patients > 65 years detects new atrial fibrillation in about 1% of people.
The CHA2DS2-VASc score was developed and validated to risk-stratify patients with atrial fibrillation into low, intermediate and high risk of stroke. The Investigators believe that the CHA2DS2-VASc score represents an opportunity to identify patients at high risk of atrial fibrillation, but also identifies this at highest risk of stroke, and therefore those that will derive greatest benefit from anticoagulant therapy.
The advent of external-worn event loop recorders (ELRs) present a more convenient and efficient method of detecting atrial fibrillation. Loop recorders have an in-built diagnostic algorithm that identifies atrial fibrillation, and initiates recordings before and after the event-trigger. This rhythm strip is then examined and confirmed by the trial cardiac technician. The investigators will examine if using external loop recorders in patients identified as high risk will improve the detection rate of paroxysmal atrial fibrillation.
The study is a randomised controlled cross-over multi-centered clinical trial in General Practice. Ethical approval has been sought from the Galway University Hospitals research ethics committee. The investigators have also engaged with Clinical Research Patient and Public Involvement.
The investigators primary research question is whether extended cardiac rhythm monitoring (with ELR for 1 week), compared to standard care, in patients pre-identified to be at high-risk of atrial fibrillation (defined by CHA2DS2-VASc score >2) increases the detection of new atrial fibrillation resulting in introduction of oral anticoagulant therapy, that is efficient, acceptable to patients and cost-effective.
All participating general practices will require the Socrates software package. The investigators will run analyses to identify patients with a CHA2DS2-VASc of 3 or greater. The investigators will exclude all patients with known atrial fibrillation, those in whom contraindications to oral anticoagulant therapy exist, and those who are deemed unsuitable for extended monitoring.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized controlled cross-over multi-centered clinical trial in General Practice, comparing; a) opportunistic pulse screening + immediate ELR device (R-Test) for 1 week; or, b) opportunistic pulse screening + delayed ELR device (R-Test) for 1 week, in patients with CHA2DS2-VASc score of 3 or greater, and without a contraindication to oral anticoagulation.
| Arm | Type | Receives |
|---|---|---|
| Immediate External Loop Recorder | Other | Device: R Test 4 External Loop RecorderParticipants randomized to the Immediate External Loop Recorder group will be monitored for the duration of the first week of the study using the Novacor R-Test 4. |
| Delayed External Loop Recorder | Other | Device: R Test 4 External Loop RecorderParticipants randomized to the Delayed External Loop Recorder group will be monitored for the duration of the second week of the study using the Novacor R-Test 4. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed a study specific Informed Consent Form
- 55 years of age or older
- Attending one of the participating General Practices in the R-BEAT Trial
- Attended at least one GP appointment within the past 12 months
- CHA2DS2-VASc Score >2
Key exclusion criteria (12 listed)
- Contraindication to oral anticoagulant therapy
- (If intolerant or refused warfarin, may be included if considered suitable for non vitamin-K oral anticoagulant, NOAC)
- Known Atrial fibrillation/flutter
- Currently prescribed oral anticoagulant therapy
- Unsuitable for anticoagulant therapy, in opinion of attending general practitioner
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 |
|---|---|---|
| R Test 4 External Loop RecorderThe R-Test 4 is an externally worn, re-usable, battery-powered, lightweight ECG monitor, which records events triggered by cardiac arrhythmias. It is worn for 7 days. Cardiac monitoring is triggered by tachycardia or detection of irregular pulses or patient may trigger recording, if the participant experience symptoms (e.g. palpitations). The patient wears 2 chest leads (on one, the R-Test device is attached, weight 42g). The R-Test 4 is CE marked, and uses an FDA-approved algorithm for automatic detection of atrial fibrillation, and permits 5 minutes of pre-event recording and 5 minutes of post-event recording. | Device | Delayed External Loop Recorder, Immediate External Loop Recorder |
Primary outcome
New detected (and centrally confirmed) cases of atrial fibrillation/flutter > 2 minutes
Time frame: 2 years
New detected (and centrally confirmed) cases of atrial fibrillation/flutter > 2 minutes in duration using a built in diagnostic algorithm that identifies probable atrial fibrillation. The identified instances will be reviewed by a cardiologist for confirmation of atrial fibrillation/atrial flutter
1 secondary outcome
Initiation of oral anticoagulation
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Derived from this study: PubMed 39786890Murphy R, Waters R, Murphy A, McDermott S, Reddin C, Hernon O, Davies N, Alvarez-Iglesias A, Twomey E, O'Shea E, Sloane P, Curran J, Kiely A, Waters C, Kilraine J, McDonagh S, Carney A, Devane D, O'Donnell M. Risk-based screening for the evaluation of atrial fibrillation in general practice (R-BEAT): a randomized cross-over trial. QJM. 2025 Mar 1;118(3):166-173. doi: 10.1093/qjmed/hcaf001.
- Individual participant dataSharing planned: No
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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.
Colin Hardy, BSc study chair
Project Officer and Site Management Coordinator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing R Test 4 External Loop Recorder in people with Atrial Fibrillation and Flutter, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.
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 5 inclusion and 12 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: finished, as of the sponsor's last update on 28 Feb 2024. 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 Ireland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
New detected (and centrally confirmed) cases of atrial fibrillation/flutter > 2 minutes (time frame: 2 years). 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 NCT03911986, which also lists 1 linked publication.
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 28 Feb 2024.