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

The Leeds Teaching Hospitals NHS Trust

Status: Enrolling

Conditions: Cardiovascular Diseases

Treatments: Device: Kardia 6L

Study type: Interventional

Funder types: Other

Identifiers

NCT05324111

CD21/140756

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

12 Lead ECG

Experimental group

Description:

Application of hand held electrocardio gram

Treatment:

Device: Kardia 6L