Risk-Based Screening for the Evaluation of Atrial Fibrillation Trial

NCT03911986 | Completed

• 1 other identifier: 17-CRFG 17
• Study Type: interventional
• Target: 755
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.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.
3. 3.To determine the sensitivity, specificity, positive predictive value and negative predictive values of self-monitoring of pulse in adults for detection of atrial fibrillation.
4. 4.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.

Conditions

Atrial Fibrillation and Flutter

Outcome Measures

Primary Outcomes (1)

• 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

  2 years

Secondary Outcomes (1)

• Initiation of oral anticoagulation

  3 months

Study Arms (2)

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.

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.

Device: R Test 4 External Loop Recorder

Interventions

R Test 4 External Loop Recorder DEVICE

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.

Delayed External Loop Recorder; Immediate External Loop Recorder

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed a study specific Informed Consent Form
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• National University of Ireland, Galway, Ireland: lead
• Health Research Board, Ireland: collaborator

Study Sites (1)

HRB Clinical Research Facility Galway

Galway, County Galway, H91 YR71, Ireland

Location

Related Publications (1)

• 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.

  PMID: 39786890 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Colin Hardy, BSc

  Project Officer and Site Management Coordinator

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: There is no masking.
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Specialist in Stroke Medicine

Model Details: 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.

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: April 11, 2019
• Study Start: March 21, 2018
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)