SL-AF Trial - (Six Lead Identification of Atrial Fibrillation [AF]) (SL-AF)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
RhythmPadGP
Sponsored by
About this trial
This is an interventional screening trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Ashford and St Peters NHS Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ECG acquisition
Arm Description
ECG acquisition using the standard ECG machine Intervention: An ECG will be performed on every participant using the novel device called the 'RhythmPadGP'
Outcomes
Primary Outcome Measures
Six Lead Identification of Atrial Fibrillation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02401451
Brief Title
SL-AF Trial - (Six Lead Identification of Atrial Fibrillation [AF])
Acronym
SL-AF
Official Title
SL-AF Trial - (Six Lead Identification of Atrial Fibrillation [AF])
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cardiocity Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
750 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ECG acquisition
Arm Type
Experimental
Arm Description
ECG acquisition using the standard ECG machine
Intervention: An ECG will be performed on every participant using the novel device called the 'RhythmPadGP'
Intervention Type
Device
Intervention Name(s)
RhythmPadGP
Intervention Description
ECG acquisition using a novel device RhythmPadGP
Primary Outcome Measure Information:
Title
Six Lead Identification of Atrial Fibrillation
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riyaz A Kaba, MBBS
Organizational Affiliation
Ashford and St Peter's Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ashford and St Peters NHS Trust
City
Surrey
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
SL-AF Trial - (Six Lead Identification of Atrial Fibrillation [AF])
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