Cardiac ArrhythmiaNCT04468477
EVALECGcardio Study
A study testing 6 Lead ECG in people with Cardiac Arrhythmia, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cardiac Arrhythmia
- What is being tested?
- 6 Lead ECG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 May 2020to 21 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Anyone attending cardiology outpatients or the ward who has had a recent ECG (within 6 hours)
Who cannot join
- Patients who do not consent to the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Leeds Teaching Hospitals NHS Trust
Leeds
Muzahir Tayebjee, MBChB MRCP MD, muzahir.tayebjee@nhs.net
About this study
Official title: An Evaluation of the Safety and Clinical Utility of Handheld ECG Technology in Cardiology
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.
Read the 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.
- Conditions
- Cardiac Arrhythmia
- Being tested
- 6 Lead ECG
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 Lead ECGDevice
Patients will be assessed with the Kardiamobile device.
| Study group | Role | What they receive |
|---|---|---|
| Patients attending cardiac outpatient clinic | Active comparator | Not described Receives: Device: 6 Lead ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start29 May 2020
- Primary completion21 May 2021 (estimated)
- Study completion21 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468477
- Sponsor's protocol ID
- CD20/130832
- Status last verified
- Jul 2020
- First submitted
- 8 Jul 2020
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Safety and Clinical Utility of Handheld ECG Technology in Cardiology
- ClinicalTrials.gov ID
- NCT04468477
- Acronym / sponsor ID
- CD20/130832
- Conditions
- Cardiac Arrhythmia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 29 May 2020 (actual)
- Primary completion
- 21 May 2021 (estimated)
- Study completion
- 21 May 2021 (estimated)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients attending cardiac outpatient clinic | Active comparator | Device: 6 Lead ECG |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Anyone attending cardiology outpatients or the ward who has had a recent ECG (within 6 hours)
Key exclusion criteria (1 listed)
- Patients who do not consent to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6 Lead ECGPatients will be assessed with the Kardiamobile device. | Device | Patients attending cardiac outpatient clinic |
Primary outcome
Difference between the 6 lead and the 12 lead Electrocardiogram
Time frame: 2 minutes
Sensitivity and specificity of handheld 6Lead compared to 12lead for the measurement of the stages of heart rhythms.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6 Lead ECG in people with Cardiac Arrhythmia, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between the 6 lead and the 12 lead Electrocardiogram (time frame: 2 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2020.