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 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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: RhythmPadGP

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 Type: Interventional
• Enrollment (Actual): 750
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Surrey, United Kingdom
    • Ashford and St Peters NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ECG acquisition; ECG acquisition using the standard ECG machine Intervention: An ECG will be performed on every participant using the novel device called the 'RhythmPadGP'	Device: RhythmPadGP; ECG acquisition using a novel device RhythmPadGP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Six Lead Identification of Atrial Fibrillation	9 months

Collaborators and Investigators

• Sponsor: Cardiocity Limited
• Investigators: Principal Investigator: Riyaz A Kaba, MBBS, Ashford and St Peter's Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: March 24, 2015
• First Submitted That Met QC Criteria: March 24, 2015
• First Posted (Estimate): March 27, 2015

Study Record Updates

• Last Update Posted (Estimate): August 10, 2016
• Last Update Submitted That Met QC Criteria: August 9, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: ACB1-1001-1941

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED