Atrial FibrillationSL-AFNCT02401451
SL-AF Trial - (Six Lead Identification of Atrial Fibrillation [AF])
A study testing RhythmPadGP in people with Atrial Fibrillation, run by Cardiocity Limited at 1 site in United Kingdom.
Trial summary
The 12-lead ECG is an essential tool in cardiovascular assessment. Novel technology has the potential to improve the diagnostic yield of arrhythmias, whilst improving the patient experience. The RhythmPadGP is a novel device which acquires a 6-lead ECG without the need for the patient to undress. 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
- What is being tested?
- RhythmPadGP
- 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
- Oct 2014to May 2016
- 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
- Age greater or equal to 18 years of age
- able to consent
- attending to St Peter's Hospital for an ECG
- No known allergies to the velcro or metal used in the RhythmPadGP leads
Who cannot join
- Age less than 18 years of age
- Not able to consent
- Allergies to the metal/velcro strap
- Medical condition affecting the wrists that may be interfered with by the attachment of the RhythmPdGP leads, such as a fractured limb that has a cast
- Those with pacemakers or other implanted cardiac devices that would interfere with the ECG recording
Trial locations and contacts
1 site in 1 country.
About this study
The 12-lead ECG is an essential tool in cardiovascular assessment. Novel technology has the potential to improve the diagnostic yield of arrhythmias, whilst improving the patient experience.
The RhythmPadGP is a novel device which acquires a 6-lead ECG without the need for the patient to undress.
Read more
The aim of the study is to assess the ability of the device to diagnose cardiac rhythms.
Simultaneous recording of the RhythmPadGP 6-lead ECG will be undertaken at the same time as the standard 12-lead ECG.
The 12-lead ECGs and 6-lead ECGs will be analysed by a Cardiologist, who will be blinded to each set of ECGs and the automated diagnostic report produced by the RhythmPadGP device.
Such a novel diagnostic tool could replace the standard 12-lead ECG for rapid assessment and diagnosis of arrhythmias. Additionally, as calls for a national screening programme to detect atrial fibrillation (and prevent AF-related thromboembolism) currently intensify, the RhythmPad has the potential to revolutionise how we screen our patients.
Read the detailed description
The concept for the Rhythm Pad is to screen the public non-invasively for a cardiac rhythm abnormality, every time that they interact with a clinician. Cardiocity have conducted significant trialing of the RhythmPad product within both the primary care setting at the Old Cottage Hospital in Epsom and in a secondary care setting at St Peter's Hospital in Chertsey. The initial results were encouraging with a simple hand screening providing an indication of AF in 66% of the confirmed cases of AF, when verified by a traditional electrocardiogram (ECG) known as a GE MAC550 12 lead device as the benchmark.
The main aim is for the RhythmPad range of products to increase the ability to diagnose cardiac rhythm abnormalities, along with reducing the number of false positive referrals to secondary care for a 12 lead Electrocardiogram of ECG. As such confirming the diagnosis before referral reduces the number of false positive referrals. If one of our algorithms thinks that there is evidence that the person might be in a state of Atrial Fibrillation (AF), Flutter, might have left or right bundle branch block, etc, then by moving to the 6 lead we are able to increase the confidence of the diagnosis.
The RhythmPad is now able to support a 6 lead ECG acquisition, this is by using a modified device called the RhythmPadGP as such we would plan to trial this technology with St Peter's Hospital. We have learnt from the experiences of the previous trails. We know that 5% of the entire population will not have strong enough Lead 1 ECG when measured from their hands. Also those with Essential Tremor, Parkinson's etc. are not able to keep their hands steady for an accurate reading to be taken. In such cases, or as an escalation from the one lead data, we now offer through a simple Velcro ankle strap attachment the ability to record 6 leads of data.
- Conditions
- Atrial Fibrillation
- Being tested
- RhythmPadGP
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RhythmPadGPDevice
ECG acquisition using a novel device RhythmPadGP
| Study group | Role | What they receive |
|---|---|---|
| ECG acquisition | Experimental | ECG acquisition using the standard ECG machine
Intervention: An ECG will be performed on every participant using the novel device called the 'RhythmPadGP' Receives: Device: RhythmPadGP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six Lead Identification of Atrial Fibrillation
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startOct 2014
- Primary completionMar 2016
- Study completionMay 2016
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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiocity Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Riyaz A Kaba, MBBS, Principal investigator, Ashford and St Peter's Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401451
- Sponsor's protocol ID
- ACB1-1001-1941
- Acronym
- SL-AF
- Status last verified
- Aug 2016
- First submitted
- 24 Mar 2015
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SL-AF Trial - (Six Lead Identification of Atrial Fibrillation [AF])
- ClinicalTrials.gov ID
- NCT02401451
- Acronym / sponsor ID
- SL-AF / ACB1-1001-1941
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Cardiocity LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 27 Mar 2015 (estimated)
- 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.
The 12-lead ECG is an essential tool in cardiovascular assessment. Novel technology has the potential to improve the diagnostic yield of arrhythmias, whilst improving the patient experience.
The RhythmPadGP is a novel device which acquires a 6-lead ECG without the need for the patient to undress.
The aim of the study is to assess the ability of the device to diagnose cardiac rhythms.
Simultaneous recording of the RhythmPadGP 6-lead ECG will be undertaken at the same time as the standard 12-lead ECG.
The 12-lead ECGs and 6-lead ECGs will be analysed by a Cardiologist, who will be blinded to each set of ECGs and the automated diagnostic report produced by the RhythmPadGP device.
Such a novel diagnostic tool could replace the standard 12-lead ECG for rapid assessment and diagnosis of arrhythmias. Additionally, as calls for a national screening programme to detect atrial fibrillation (and prevent AF-related thromboembolism) currently intensify, the RhythmPad has the potential to revolutionise how we screen our patients.
Detailed description
The concept for the Rhythm Pad is to screen the public non-invasively for a cardiac rhythm abnormality, every time that they interact with a clinician. Cardiocity have conducted significant trialing of the RhythmPad product within both the primary care setting at the Old Cottage Hospital in Epsom and in a secondary care setting at St Peter's Hospital in Chertsey. The initial results were encouraging with a simple hand screening providing an indication of AF in 66% of the confirmed cases of AF, when verified by a traditional electrocardiogram (ECG) known as a GE MAC550 12 lead device as the benchmark.
The main aim is for the RhythmPad range of products to increase the ability to diagnose cardiac rhythm abnormalities, along with reducing the number of false positive referrals to secondary care for a 12 lead Electrocardiogram of ECG. As such confirming the diagnosis before referral reduces the number of false positive referrals. If one of our algorithms thinks that there is evidence that the person might be in a state of Atrial Fibrillation (AF), Flutter, might have left or right bundle branch block, etc, then by moving to the 6 lead we are able to increase the confidence of the diagnosis.
The RhythmPad is now able to support a 6 lead ECG acquisition, this is by using a modified device called the RhythmPadGP as such we would plan to trial this technology with St Peter's Hospital. We have learnt from the experiences of the previous trails. We know that 5% of the entire population will not have strong enough Lead 1 ECG when measured from their hands. Also those with Essential Tremor, Parkinson's etc. are not able to keep their hands steady for an accurate reading to be taken. In such cases, or as an escalation from the one lead data, we now offer through a simple Velcro ankle strap attachment the ability to record 6 leads of data.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECG acquisition | Experimental | Device: RhythmPadGPECG acquisition using the standard ECG machine Intervention: An ECG will be performed on every participant using the novel device called the 'RhythmPadGP' |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age greater or equal to 18 years of age
- able to consent
- attending to St Peter's Hospital for an ECG
- No known allergies to the velcro or metal used in the RhythmPadGP leads
Key exclusion criteria (5 listed)
- Age less than 18 years of age
- Not able to consent
- Allergies to the metal/velcro strap
- Medical condition affecting the wrists that may be interfered with by the attachment of the RhythmPdGP leads, such as a fractured limb that has a cast
- Those with pacemakers or other implanted cardiac devices that would interfere with the ECG recording
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 |
|---|---|---|
| RhythmPadGPECG acquisition using a novel device RhythmPadGP | Device | ECG acquisition |
Primary outcome
Six Lead Identification of Atrial Fibrillation
Time frame: 9 months
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 10 Aug 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Atrial Fibrillation
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
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CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
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Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Riyaz A Kaba, MBBS principal investigator
Ashford and St Peter's Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RhythmPadGP in people with Atrial Fibrillation, run by Cardiocity Limited 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 10 Aug 2016. 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?
Six Lead Identification of Atrial Fibrillation (time frame: 9 months). 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 10 Aug 2016.