NCT03524625

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Royal Devon and Exeter NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation

Timeline

• Start date: 2018-07-13
• Primary completion: 2019-01-31
• Completion: 2019-03-01
• First posted: 2018-05-15
• Last updated: 2018-11-06

Locations

1 site across 1 country: United Kingdom