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Clinical Trials/NCT05324111
NCT05324111
Unknown
Not Applicable

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 Trust1 site in 1 country200 target enrollmentAugust 4, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
The Leeds Teaching Hospitals NHS Trust
Enrollment
200
Locations
1
Primary Endpoint
Sensitivity and specificity of adaptation to handheld 6Lead
Last Updated
4 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. 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.

Registry
clinicaltrials.gov
Start Date
August 4, 2021
End Date
February 7, 2023
Last Updated
4 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

  • 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

Outcomes

Primary Outcomes

Sensitivity and specificity of adaptation to handheld 6Lead

Time Frame: 10 Minutes

Sensitivity and specificity of adaptation to handheld 6Lead compared to 12 lead for leads V1 and V6 for the measurement of PR, QRS duration and QT interval

Secondary Outcomes

  • Assessment of other ECG parameters(10 Minutes)

Study Sites (1)

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