Atrial FibrillationNCT03501836
Wireless Handheld 8-lead ECG Device Performance in Heart Patients (Rapid Rhythm)
A study testing Rapid Rhythm Handheld 8-lead ECG Device in people with Atrial Fibrillation and Heart Murmurs, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study is designed to compare the performance of both 6 and 10 electrode ECGs from the handheld device with the conventional 12 lead ECG. As well as comparing the detection of atrial fibrillation, the study will also compare the detection of other heart problems and of normal heart rhythm. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Heart Murmurs
- What is being tested?
- Rapid Rhythm Handheld 8-lead ECG Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Jan 2017to 30 Jun 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient attending an adult cardiology or anti-coagulation clinic appointment, at clinics at Central Manchester University Hospitals NHS Foundation Trust (including the Manchester Heart Centre).
- Patients on cardiac wards 3 and 4.
- Aged 18 years or above.
- Male or Female.
Who cannot join
- Aged less than 18 years.
- Unable to give informed consent.
- Does not wish to participate in the study.
- Any patients with visible breaks to the skin, rashes or inflammation in the chest area on the day of the test
- Bedridden or otherwise unable to transfer between chair and bed for both seated and supine measurements
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University NHS Foundation Trust
Manchester, M13 9WL
About this study
Official title: Performance Evaluation Study of a Six Electrode (8 Lead) Wireless Handheld ECG Recording Device With Four Lead Chest Extension Versus Conventional 12-lead ECG in Heart Patients
This study is designed to compare the performance of both 6 and 10 electrode ECGs from the handheld device with the conventional 12 lead ECG. As well as comparing the detection of atrial fibrillation, the study will also compare the detection of other heart problems and of normal heart rhythm.
Read the detailed description
An Electrocardiogram (ECG) 6 electrode, wireless handheld device held on the chest is being developed to allow diagnosis of heart rhythm problems without the need for connecting electrodes to the chest, arms and legs as in a standard 10 electrode (referred to as a 12-lead) ECG measurement. A faster and simpler yet accurate method for acquiring ECG data may be useful in many healthcare settings, including screening for irregular heart rhythms such as Atrial Fibrillation (AF), which is a risk factor for stroke. The wireless 6 electrode device has an extension arm for the handset with 4 additional electrodes (also positioned on the chest) to give a full 12 lead ECG signal. This study is designed to compare the performance of both 6 and 10 electrode ECGs from the handheld device (used on the chest with the subject seated) with the conventional 12 lead ECG (used with electrodes on the chest, arms and legs with the subject lying down). As well as comparing the detection of atrial fibrillation, the study will also compare the detection of other heart problems and of normal heart rhythm. Adult patients attending the clinics at Central Manchester University Hospitals NHS Foundation Trust for an ECG assessment are eligible to participate in the study. A maximum of 500 patients will be recruited to the study in order to find the number of cases with Atrial Fibrillation required to properly compare the methods. A subset of patients with normal ECGs will have additional measurements with both methods whilst lying down, reclining at an angle and sitting upright to investigate any effects of body posture on chest based ECGs.
- Conditions
- Atrial Fibrillation, Heart Murmurs
- Being tested
- Rapid Rhythm Handheld 8-lead ECG Device
- Medical subject headings
- Atrial Fibrillation, Heart Murmurs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Rhythm Handheld 8-lead ECG DeviceDevice
We want to explore whether using 6 electrodes on the chest (as in the Rapid Rhythm Handheld 8-lead ECG device) can give the same diagnostic result to the standard 10 electrode (12-lead) ECG, which uses 6 chest electrodes plus 4 electrodes on the arms and legs.
To do this we need to compare measurements taken with the 6 electrode (8 lead) study device to those taken with the gold-standard 10 electrode (12 lead) method.
We want to find out whether the new equipment can detect the same heart rhythms as the standard method, so that ECG measurements might be made more quickly and easily in the future.
| Study group | Role | What they receive |
|---|---|---|
| Rapid Rhythm Handheld 8-lead ECG Device | Experimental | Participants will have measurements taken with the 8 lead ECG system, which will be compared to the conventional standard care 12 lead ECG. Receives: Device: Rapid Rhythm Handheld 8-lead ECG Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capabilities of an 8 lead ECG system (Rapid Rhythm) - normal ECGs
The percentage of ECGs where a normal control ECG is matched by a normal RR ECG.
Measured: 18 months
Capabilities of an 8 lead ECG system (Rapid Rhythm) - abnormal ECGs
The percentage of ECGs where abnormalities of the control ECG are matched by similar abnormalities of the RR ECG.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start24 Jan 2017
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Rapid Rhythm Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501836
- Sponsor's protocol ID
- 160483
- Other IDs
- R04118
- Status last verified
- Feb 2025
- First submitted
- 9 Apr 2018
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation Study of a Six Electrode (8 Lead) Wireless Handheld ECG Recording Device With Four Lead Chest Extension Versus Conventional 12-lead ECG in Heart Patients
- ClinicalTrials.gov ID
- NCT03501836
- Acronym / sponsor ID
- 160483
- Conditions
- Atrial Fibrillation, Heart Murmurs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- Rapid Rhythm Ltd
- Study start
- 24 Jan 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 18 Apr 2018 (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.
This study is designed to compare the performance of both 6 and 10 electrode ECGs from the handheld device with the conventional 12 lead ECG. As well as comparing the detection of atrial fibrillation, the study will also compare the detection of other heart problems and of normal heart rhythm.
Detailed description
An Electrocardiogram (ECG) 6 electrode, wireless handheld device held on the chest is being developed to allow diagnosis of heart rhythm problems without the need for connecting electrodes to the chest, arms and legs as in a standard 10 electrode (referred to as a 12-lead) ECG measurement. A faster and simpler yet accurate method for acquiring ECG data may be useful in many healthcare settings, including screening for irregular heart rhythms such as Atrial Fibrillation (AF), which is a risk factor for stroke. The wireless 6 electrode device has an extension arm for the handset with 4 additional electrodes (also positioned on the chest) to give a full 12 lead ECG signal. This study is designed to compare the performance of both 6 and 10 electrode ECGs from the handheld device (used on the chest with the subject seated) with the conventional 12 lead ECG (used with electrodes on the chest, arms and legs with the subject lying down). As well as comparing the detection of atrial fibrillation, the study will also compare the detection of other heart problems and of normal heart rhythm. Adult patients attending the clinics at Central Manchester University Hospitals NHS Foundation Trust for an ECG assessment are eligible to participate in the study. A maximum of 500 patients will be recruited to the study in order to find the number of cases with Atrial Fibrillation required to properly compare the methods. A subset of patients with normal ECGs will have additional measurements with both methods whilst lying down, reclining at an angle and sitting upright to investigate any effects of body posture on chest based ECGs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rapid Rhythm Handheld 8-lead ECG Device | Experimental | Device: Rapid Rhythm Handheld 8-lead ECG DeviceParticipants will have measurements taken with the 8 lead ECG system, which will be compared to the conventional standard care 12 lead ECG. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient attending an adult cardiology or anti-coagulation clinic appointment, at clinics at Central Manchester University Hospitals NHS Foundation Trust (including the Manchester Heart Centre).
- Patients on cardiac wards 3 and 4.
- Aged 18 years or above.
- Male or Female.
Key exclusion criteria (5 listed)
- Aged less than 18 years.
- Unable to give informed consent.
- Does not wish to participate in the study.
- Any patients with visible breaks to the skin, rashes or inflammation in the chest area on the day of the test
- Bedridden or otherwise unable to transfer between chair and bed for both seated and supine measurements
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 |
|---|---|---|
| Rapid Rhythm Handheld 8-lead ECG DeviceWe want to explore whether using 6 electrodes on the chest (as in the Rapid Rhythm Handheld 8-lead ECG device) can give the same diagnostic result to the standard 10 electrode (12-lead) ECG, which uses 6 chest electrodes plus 4 electrodes on the arms and legs. To do this we need to compare measurements taken with the 6 electrode (8 lead) study device to those taken with the gold-standard 10 electrode (12 lead) method. We want to find out whether the new equipment can detect the same heart rhythms as the standard method, so that ECG measurements might be made more quickly and easily in the future. | Device | Rapid Rhythm Handheld 8-lead ECG Device |
Primary outcome
Capabilities of an 8 lead ECG system (Rapid Rhythm) - normal ECGs
Time frame: 18 months
The percentage of ECGs where a normal control ECG is matched by a normal RR ECG.
Capabilities of an 8 lead ECG system (Rapid Rhythm) - abnormal ECGs
Time frame: 18 months
The percentage of ECGs where abnormalities of the control ECG are matched by similar abnormalities of the RR ECG.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid Rhythm Handheld 8-lead ECG Device in people with Atrial Fibrillation and Heart Murmurs, run by Manchester University NHS Foundation 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 5 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Capabilities of an 8 lead ECG system (Rapid Rhythm) - normal ECGs (time frame: 18 months). The study lists 2 primary outcomes in all. 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 5 Feb 2025.