EVALECGcardio Study

Sponsor

The Leeds Teaching Hospitals NHS Trust (Other)

Overall Status

Unknown status

CT.gov ID

NCT04468477

Collaborator

(none)

750

Enrollment

Location

Arm

11.7

Anticipated Duration (Months)

63.9

Patients Per Site Per Month

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. 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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrhythmia	Device: 6 Lead ECG	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

750 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

May 29, 2020

Anticipated Primary Completion Date :

May 21, 2021

Anticipated Study Completion Date :

May 21, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Patients attending cardiac outpatient clinic	Device: 6 Lead ECG Patients will be assessed with the Kardiamobile device.

Arm

Intervention/Treatment

Active Comparator: Patients attending cardiac outpatient clinic

Device: 6 Lead ECG

Patients will be assessed with the Kardiamobile device.

Outcome Measures

Primary Outcome Measures

Difference between the 6 lead and the 12 lead Electrocardiogram [2 minutes]
Sensitivity and specificity of handheld 6Lead compared to 12lead for the measurement of the stages of heart rhythms.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Leeds Teaching Hospitals NHS Trust	Leeds		United Kingdom

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:

NCT04468477

Other Study ID Numbers:

CD20/130832

First Posted:

Jul 13, 2020

Last Update Posted:

Jul 13, 2020

Last Verified:

Jul 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Arrhythmias, Cardiac

Study Results

No Results Posted as of Jul 13, 2020