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Clinical Trials/NCT04468477
NCT04468477
Unknown
Not Applicable

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

The Leeds Teaching Hospitals NHS Trust1 site in 1 country750 target enrollmentMay 29, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Arrhythmia
Sponsor
The Leeds Teaching Hospitals NHS Trust
Enrollment
750
Locations
1
Primary Endpoint
Difference between the 6 lead and the 12 lead Electrocardiogram
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 29, 2020
End Date
May 21, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
The Leeds Teaching Hospitals NHS Trust
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Difference between the 6 lead and the 12 lead Electrocardiogram

Time Frame: 2 minutes

Sensitivity and specificity of handheld 6Lead compared to 12lead for the measurement of the stages of heart rhythms.

Study Sites (1)

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