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

• Sponsor: The Leeds Teaching Hospitals NHS Trust (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05324111
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 18.1
• Patients Per Site Per Month: 11

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases	Device: Kardia 6L	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: 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
• Actual Study Start Date: Aug 4, 2021
• Anticipated Primary Completion Date: Feb 7, 2023
• Anticipated Study Completion Date: Feb 7, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 12 Lead ECG Application of hand held electrocardio gram	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

Outcome Measures

Primary Outcome Measures

1. Sensitivity and specificity of adaptation to handheld 6Lead [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 Outcome Measures

1. Assessment of other ECG parameters [10 Minutes]

   Assessment of other ECG parameters e.g. ST segment change in the ECG wave

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Leeds Teaching Hospital NHS Trust	Leeds		United Kingdom	LS9 7TF

Sponsors and Collaborators

• The Leeds Teaching Hospitals NHS Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Leeds Teaching Hospitals NHS Trust
• ClinicalTrials.gov Identifier: NCT05324111
• Other Study ID Numbers: CD21/140756
• First Posted: Apr 12, 2022
• Last Update Posted: Apr 12, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cardiovascular Diseases

Study Results

No Results Posted as of Apr 12, 2022