Sensitivity and Specificity of a Mobile Lead-one ECG Like Device for the Detection of Atrial Fibrillation (AF)

• Conditions: Atrial Fibrillation

• Registration Number: NCT03524625
• Lead Sponsor: Royal Devon and Exeter NHS Foundation Trust

Brief Summary

Atrial Fibrillation(AF) is one of the most common abnormal heart rhythms and approximately 3% of the general population have AF. The prevalence increases with age of the population and is increased in people with diabetes, hypertension and those who are overweight. AF is a major risk factor for stroke; people with AF are five times more likely to suffer an ischaemic stroke; however this can be reduced significantly with appropriate interventions which depends on detection of the abnormal rhythm. Although the National Institute of Health and Care Excellence (NICE) currently recommends screening patients with symptoms of AF, including syncope, heart palpitations, and chest discomfort, as well as patients who have suffered a stroke or heart attack, many patients remain symptomless and are not managed for their increased stroke risk. Guidelines for AF screening include manual palpation of a peripheral pulse, followed up by an ECG for patients who have an irregular pulse. Although almost all patients with AF have an irregular pulse, only about 12 in 100 patients with an irregular pulse have AF. Use of an improved screening tool for AF could both cut down the number of people undergoing unnecessary ECGs, and also lead the way for a wider screening programme for AF. The aim of this study is to investigate the sensitivity and specificity of a new ECG like device for the detection of AF, the Plessey imPulse. Participants referred or admitted to secondary care with stroke symptoms and other indicators of increased prevalence of AF will be recruited. Participants will undergo three methods of AF screening, a peripheral pulse, a lead-one like ECG using the imPulse device, and the gold-standard for AF detection, a 12-lead ECG. By comparing to the ECG results specificity and sensitivity will be established for both methods in this population.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-02
• Study First Submitted QC: 2018-05-02
• Study First Posted: 2018-05-15
• Study Start: 2018-07-13
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-05
• Last Update Posted: 2018-11-06
• Primary Completion: 2019-01-31
• Study Completion: 2019-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Patients with AF or suspected AF referred or admitted to hospital (secondary care setting). Able to hold the impulse device with both hands. Able to give informed consent.

Exclusion Criteria

Patients who are unable to give informed consent either through lack of capacity or lack of ability to understand study documentation. Patients who are unable to hold the impulse device for 2mins. Presence of artificial pacemaker or cardioverter defibrillator.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of the Plessey imPulse lead-I ECG like device for detecting AF.	6months	The primary aim of this study is to evaluate the diagnostic accuracy of the Plessey imPulse lead-I ECG like device for detecting AF.; Objectives: * Assess sensitivity; * Assess specificity; * Assess positive predictive value; * Assess negative predictive value In addition to providing estimates of diagnostic performance of the impulse device, the results of this study are intended to inform the trajectory to undertake a follow up study to confirm diagnostic performance in primary care practice setting and its acceptability and clinical utility.

Trial Locations

Locations (1)

Royal Devon and Exeter NHS Trust; 🇬🇧 Exeter, Devon, United Kingdom