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Risk-Based Screening for the Evaluation of Atrial Fibrillation Trial

NCT03911986 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 755

Last updated 2024-02-28

No results posted yet for this study

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. 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. 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. 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

Interventions

DEVICE

R Test 4 External Loop Recorder

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.

Sponsors & Collaborators

  • Health Research Board, Ireland

    collaborator OTHER

  • National University of Ireland, Galway, Ireland

    lead OTHER

Principal Investigators

  • Colin Hardy, BSc · Project Officer and Site Management Coordinator

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-21
Primary Completion
2023-06-30
Completion
2023-12-31

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03911986 on ClinicalTrials.gov