SL-AF Trial - (Six Lead Identification of Atrial Fibrillation [AF]) (SL-AF)
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 are to be analysed by a Cardiologist, who will beblinded 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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Screening
|Official Title:||SL-AF Trial - (Six Lead Identification of Atrial Fibrillation [AF])|
- Six Lead Identification of Atrial Fibrillation [ Time Frame: 9 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2014|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Experimental: ECG acquisition
ECG acquisition using the standard ECG machine and novel device will be performed on every participant
ECG acquisition using a novel device
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.
Previously we recorded ECG from patients as they attended the ECG clinic at St Peter's AFTER they had undertaken the 12 lead ECG. Our results showed there were a number of AF cases that did not correlate between the 12 lead and the 1 lead, this may have occurred as the ECG's were not taken at the same time.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02401451
|Contact: Chris Crockford, PhD||44 783 188 3287||Chris.Crockford@cardiocity.com|
|Contact: Isaac John, PhD||44 193 272 2901||Isaac.John@nhs.net|
|Ashford and St Peters NHS Trust||Recruiting|
|Surrey, United Kingdom|
|Contact: Isaac John, PHD 01932723534 email@example.com|
|Principal Investigator:||Riyaz A Kaba, MBBS||Ashford and St Peter's Hospitals NHS Foundation Trust|