EVALECGcardio Study

Not Applicable

• Conditions: Cardiac Arrhythmia
• Interventions: Device: 6 Lead ECG

• Registration Number: NCT04468477
• Lead Sponsor: The Leeds Teaching Hospitals NHS Trust

Brief Summary

ECGs are routinely performed in cardiology. Recently handheld ECGs have shown promise in screening for heart rhythm disorders. These are quick to perform and do not require the preparation that is needed for 12 lead ECGs. We wanted to test whether a novel handheld ECG recorder, Kardia 6L, which has the potential to record a 6 lead ECG is able to screen for ECG abnormalities, thereby obviating the need for a full 12 lead ECG. This may allow for earlier diagnosis and treatment.

Detailed Description

The aim of analysis is to determine if the handheld 6 lead ECG can be used as a simple screener to identify patients who do not need a 12 lead ECG.

Study Timeline

• Study Start: 2020-05-29
• Status Verified: 2020-07
• Study First Submitted: 2020-07-08
• Study First Submitted QC: 2020-07-08
• Last Update Submitted: 2020-07-08
• Study First Posted: 2020-07-13
• Last Update Posted: 2020-07-13
• Primary Completion: 2021-05-21
• Study Completion: 2021-05-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

• Anyone attending cardiology outpatients or the ward who has had a recent ECG (within 6 hours)

Exclusion Criteria

• Patients who do not consent to the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients attending cardiac outpatient clinic	6 Lead ECG	-

Primary Outcome Measures

Name	Time	Method
Difference between the 6 lead and the 12 lead Electrocardiogram	2 minutes	Sensitivity and specificity of handheld 6Lead compared to 12lead for the measurement of the stages of heart rhythms.

Trial Locations

Locations (1)

Leeds Teaching Hospitals NHS Trust; 🇬🇧 Leeds, United Kingdom