NCT05324111

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: The Leeds Teaching Hospitals NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
DEVICE	Kardia 6L	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

Timeline

• Start date: 2021-08-04
• Primary completion: 2023-02-07
• Completion: 2023-02-07
• First posted: 2022-04-12
• Last updated: 2022-04-12

Locations

1 site across 1 country: United Kingdom