NCT04468477

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
750

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 29, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 8, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 13, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2021

Completed
Last Updated

July 13, 2020

Status Verified

July 1, 2020

Enrollment Period

12 months

First QC Date

July 8, 2020

Last Update Submit

July 8, 2020

Conditions

Cardiac Arrhythmia

Outcome Measures

Primary Outcomes (1)

  • Difference between the 6 lead and the 12 lead Electrocardiogram

    Sensitivity and specificity of handheld 6Lead compared to 12lead for the measurement of the stages of heart rhythms.

    2 minutes

Study Arms (1)

Patients attending cardiac outpatient clinic

ACTIVE COMPARATOR
Device: 6 Lead ECG

Interventions

6 Lead ECGDEVICE

Patients will be assessed with the Kardiamobile device.

Patients attending cardiac outpatient clinic

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Anyone attending cardiology outpatients or the ward who has had a recent ECG (within 6 hours)

You may not qualify if:

  • Patients who do not consent to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2020

First Posted

July 13, 2020

Study Start

May 29, 2020

Primary Completion

May 21, 2021

Study Completion

May 21, 2021

Last Updated

July 13, 2020

Record last verified: 2020-07

Locations

GB(1)