Cardiac Arrhythmia Clinical Trial
Official title:
An Evaluation of the Safety and Clinical Utility of Handheld ECG Technology in Cardiology
NCT number | NCT04468477 |
Other study ID # | CD20/130832 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 29, 2020 |
Est. completion date | May 21, 2021 |
Verified date | July 2020 |
Source | The Leeds Teaching Hospitals NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 750 |
Est. completion date | May 21, 2021 |
Est. primary completion date | May 21, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Leeds Teaching Hospitals NHS Trust | Leeds |
Lead Sponsor | Collaborator |
---|---|
The Leeds Teaching Hospitals NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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