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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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05324111
Acronym
LOCAL-ECG
Enrollment
200
Registered
2022-04-12
Start date
2021-08-04
Completion date
2023-02-07
Last updated
2022-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

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.

Interventions

DEVICEKardia 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

Sponsors

The Leeds Teaching Hospitals NHS Trust
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity and specificity of adaptation to handheld 6Lead10 MinutesSensitivity 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

MeasureTime frameDescription
Assessment of other ECG parameters10 MinutesAssessment of other ECG parameters e.g. ST segment change in the ECG wave

Countries

United Kingdom

Contacts

Primary ContactMuzahir Tayebjee, MBChB (Hons), MD, MRCP
muzahir.tayebjee@nhs.net01132066051

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026