Title: Stroke reduction via improved opportunistic screening for atrial fibrillation. An evaluation of the clinical and economic benefits of the Rapidrhythm device within primary care.
Funder: Department of Health (England)

Abstract: To date we have made the following progress in developing and evaluating the Rapidrhythm device. The development and testing of a hand held ECG electrode interface that is held against the chest and enables ECG recordings to be collected from a seated patient in 60-90 secs, without undressing. In blind, randomised trials this demonstrated high levels of sensitivity and specificity for the detection of AF in comparison to 12 channel ECG recordings (0.95 & 0.97, p Securing a £90k SBRI award from NHS South East Coast Strategic Health Authority. This funded the incorporation of the electrode interface into a prototype hand held device that communicates wirelessly with a laptop and the development and clinical evaluation of a software algorithm to automatically diagnose AF from the 4-electrode ECG data. Setting up Rapid Rhythm Ltd as a vehicle to commercialise the Rapidrhythm device and securing an initial £50k venture capital investment to fund further design and market research studies. The research is summarised as follows: Primary Care Modelling Using existing studies on AF screening and discussions with GPs and patients we will undertake some initial modelling of the optimal use of the device in clinical practice. The outputs of this work will feed into the design of the second generation prototype and the large scale clinical evaluation. Second generation prototype Further prototype development work is required to convert our existing prototype into a device suitable for clinical evaluation by primary care clinicians, including electronics development, software development and product design. Most of this work will be subcontracted to ML Electronics Limited, a specialist medical electronics design and prototyping company. It will be undertaken to appropriate quality standards to meet the requirements for CE marking under the EU Medical Device Directive. Primary care based clinical trial A clinical trial of the device will be implemented within a number of GP practices and other primary care settings. The aim of this trial will be to demonstrate the potential of the device to screen elderly people for AF and to influence their subsequent treatment. This trial will be undertaken in North West GP practices and care homes with the support of Medvance Ltd, a specialist medical device trials support company. Health economics assessment Working with the University of Manchester Health Economics department we will use the data collected during the clinical trial to evaluate the health economics of Rapidrhythm for AF screening. A comparison will be made with existing methods of detecting AF within the NHS and the care costs associated with undiagnosed AF and AF related strokes. This will hopefully provide a compelling case for GPs, commissioning groups and healthcare providers to invest in the device. Market Research We will undertake market research to obtain the opinions of a range of stakeholders on the clinical utility of the device and how it could impact on their approach to AF detection and management. Such stakeholders are likely to include GPs, commissioning groups, cardiologists, anticoagulation drug companies, the Atrial Fibrillation Association, patient groups and organisations such as NICE. The work will be undertaken by Trustech. Promotion of the Rapid Rhythm device Working with an external marketing partner and using the results of all the previous activities we will devise and deliver a campaign to promote the anticipated benefits of the device to stakeholders in order to encourage adoption of the Rapid Rhythm device within the NHS once it is commercially available.


Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health categories: STROKE;CARDIOVASCULAR