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
LOCAL-ECG
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cardiovascular-diseases
Started Aug 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 4, 2021
CompletedFirst Submitted
Initial submission to the registry
March 31, 2022
CompletedFirst Posted
Study publicly available on registry
April 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 7, 2023
CompletedApril 12, 2022
April 1, 2022
1.5 years
March 31, 2022
April 11, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivity and specificity of adaptation to handheld 6Lead
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
10 Minutes
Secondary Outcomes (1)
Assessment of other ECG parameters
10 Minutes
Study Arms (1)
12 Lead ECG
EXPERIMENTALApplication of hand held electrocardio gram
Interventions
The Kardia 6L has CE marking. The purpose of this study is to extend the use of this device by a simple modification using existing equipment in the department. The device will be connected to the left leg electrodes using standard clinical crocodile clips and the other electrode applied to the chest in V1 and V6 positions to acquire the modified V1 and V6 leads
Eligibility Criteria
You may qualify if:
- Any patient who is attending the cardiology clinic or an inpatient on the cardiology ward who consents to taking part
You may not qualify if:
- Patients who are unable or refuse to consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Leeds Teaching Hospital NHS Trust
Leeds, LS9 7TF, United Kingdom
MeSH Terms
Conditions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2022
First Posted
April 12, 2022
Study Start
August 4, 2021
Primary Completion
February 7, 2023
Study Completion
February 7, 2023
Last Updated
April 12, 2022
Record last verified: 2022-04