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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03524625
• Other study ID #: 1806643
• Status: Recruiting
• Start date: July 13, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: November 2018
• Source: Royal Devon and Exeter NHS Foundation Trust
• Contact: Chris Clark, MD
• Phone: +44 (0)1392 724837
• Email: info.stlukes[@]exeter.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 1, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
United Kingdom	Royal Devon and Exeter NHS Trust	Exeter	Devon

Sponsors (2)

Lead Sponsor	Collaborator
Royal Devon and Exeter NHS Foundation Trust	University of Exeter

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of the Plessey imPulse lead-I ECG like device for detecting AF.	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.	6months