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

Cardiovascular Diseases Clinical Trial

— LOCAL-ECG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05324111
• Other study ID #: CD21/140756
• Status: Recruiting
• Phase: N/A
• Start date: August 4, 2021
• Est. completion date: February 7, 2023

Study information

• Verified date: April 2022
• Source: The Leeds Teaching Hospitals NHS Trust
• Contact: Muzahir Tayebjee, MBChB (Hons), MD, MRCP
• Phone: 01132066051
• Email: muzahir.tayebjee[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 7, 2023
• Est. primary completion date: February 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Device:
• Kardia 6L
The Kardia 6L has CE marking. The purpose of this study is to extend the use of this device by a simple modification using existing equipment in the department. The device will be connected to the left leg electrodes using standard clinical crocodile clips and the other electrode applied to the chest in V1 and V6 positions to acquire the modified V1 and V6 leads

Locations

Country	Name	City	State
United Kingdom	Leeds Teaching Hospital NHS Trust	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of adaptation to handheld 6Lead	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	10 Minutes
Secondary	Assessment of other ECG parameters	Assessment of other ECG parameters e.g. ST segment change in the ECG wave	10 Minutes