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

T

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)

200 participants in 1 patient group

12 Lead ECG
Experimental group
Description:
Application of hand held electrocardio gram
Treatment:
Device: Kardia 6L

Trial contacts and locations

1

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Central trial contact

Muzahir Tayebjee, MBChB (Hons), MD, MRCP

Data sourced from clinicaltrials.gov

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