EVALECGcardio Study

The Leeds Teaching Hospitals NHS Trust

Status: Unknown

Conditions: Cardiac Arrhythmia

Treatments: Device: 6 Lead ECG

Study type: Interventional

Funder types: Other

Identifiers

NCT04468477

CD20/130832

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. We wanted to test whether a novel 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.

Full description

The aim of analysis is to determine if the handheld 6 lead ECG can be used as a simple screener to identify patients who do not need a 12 lead ECG.

Enrollment: 750 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Anyone attending cardiology outpatients or the ward who has had a recent ECG (within 6 hours)

Exclusion criteria

• Patients who do not consent to the study

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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750 participants in 1 patient group

Patients attending cardiac outpatient clinic

Active Comparator group

Treatment:

Device: 6 Lead ECG