VaLidation of the Simple Adaptation of the Kardia 6L ECG Recorder to Obtain Chest leAd equivaLents: a Multi-centre International (LOCAL-ECG) Study; on Behalf of the Africa Heart Rhythm Association Investigators

Not Applicable

• Conditions: Cardiovascular Diseases
• Interventions: Device: Kardia 6L

• Registration Number: NCT05324111
• 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. The aim is to test whether a novel adaptation to a 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 and has implications in the prevention of infection.

The lead author recently published a pilot study showing the clinical utility of this technique and the aim of this study is to validate the method.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-04
• Study First Submitted: 2022-03-31
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-11
• Last Update Submitted: 2022-04-11
• Study First Posted: 2022-04-12
• Last Update Posted: 2022-04-12
• Primary Completion: 2023-02-07
• Study Completion: 2023-02-07

Recruitment & Eligibility

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

Inclusion Criteria

• Any patient who is attending the cardiology clinic or an inpatient on the cardiology ward who consents to taking part

Exclusion Criteria

• Patients who are unable or refuse to consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
12 Lead ECG	Kardia 6L	Application of hand held electrocardio gram

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of adaptation to handheld 6Lead	10 Minutes	Sensitivity and specificity of adaptation to handheld 6Lead compared to 12 lead for leads V1 and V6 for the measurement of PR, QRS duration and QT interval

Secondary Outcome Measures

Name	Time	Method
Assessment of other ECG parameters	10 Minutes	Assessment of other ECG parameters e.g. ST segment change in the ECG wave

Trial Locations

Locations (1)

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