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EVALECGcardio Study

An Evaluation of the Safety and Clinical Utility of Handheld ECG Technology in Cardiology

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04468477
Enrollment
750
Registered
2020-07-13
Start date
2020-05-29
Completion date
2021-05-21
Last updated
2020-07-13

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

Conditions

Cardiac Arrhythmia

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. 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.

Detailed 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.

Interventions

DEVICE6 Lead ECG

Patients will be assessed with the Kardiamobile device.

Sponsors

The Leeds Teaching Hospitals NHS Trust
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Difference between the 6 lead and the 12 lead Electrocardiogram2 minutesSensitivity and specificity of handheld 6Lead compared to 12lead for the measurement of the stages of heart rhythms.

Countries

United Kingdom

Outcome results

None listed

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