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The Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis Study
Sponsor: University of Leicester
Summary
Aortic stenosis (AS) affects approximately 5% of individuals \>65 years old, with \~3% of people \>75 years having moderate to severe disease. The prevalence of AS is rising rapidly due to an ageing population and is projected to double in the next two decades. Increasingly clinicians face the dilemma of how to best manage this growing population of mainly elderly patients, many of whom are asymptomatic but have been identified as having severe AS, often as an incidental finding. Reduced aortic valve opening progresses over decades without any apparent symptoms because the heart compensates for the AS. Ultimately, compensatory mechanisms fail resulting in angina, syncope or heart failure. If these symptomatic patients with severe AS remain untreated, they have a dire prognosis. In this situation the only effective treatment is AVR, either surgically or using TAVI. Conversely, conventional teaching and clinical practice in cardiology has been that, in the absence of symptoms, the prognosis is usually excellent and, except in a few very specific circumstances, conservative management and regular review (expectant management) is recommended. This advice is reflected in current international guidelines but is based largely on historical precedent. There has never been a randomised controlled trial to address the relative benefits of early AVR versus expectant management in patients with severe asymptomatic AS. The relative benefits of a strategy of early AVR/TAVI versus expectant management in patients with asymptomatic severe AS are unclear. There is clinical equipoise but it remains one of the few areas of cardiovascular medicine where no randomised controlled trials (RCT) have been performed. The EASY-AS study will provide crucial data on the relative merits of these differing approaches to management, in terms of important patient orientated outcomes, conventional cardiovascular end-points and cost effectiveness.
Official title: A Randomised Controlled Trial of Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2844
Start Date
2020-03-10
Completion Date
2031-04-01
Last Updated
2025-09-25
Healthy Volunteers
No
Conditions
Interventions
Aortic valve replacement
Participants will be assessed by a member of the surgical team performing aortic valve replacement (AVR), and by any other relevant medical professionals identified by the doctors overseeing their care in hospital. When deemed ready for AVR, a member of the surgical team will ask for consent to proceed with the AVR. They will discuss the surgical procedure, covering information on the basic technical procedure, risks and expected recovery time.
Locations (110)
Canberra Hospital
Garran, Australian Capital Territory, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Wollongong Hospital
Wollongong, New South Wales, Australia
Prince Charles Hospital
Chermside, Queensland, Australia
Townsville Hospital
Douglas, Queensland, Australia
The Gold Coast Hospital
Southport, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Adelaide, South Australia, Australia
Monash Health
Clayton, Victoria, Australia
University Hospital Geelong
Geelong, Victoria, Australia
Fiona Stanley Hospital
Perth, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Lyell McEwin Hospital
Elizabeth Vale, Australia
Northern Hospital
Epping, Australia
Royal Hobart Hospital
Hobart, Australia
Nepean Hospital
Kingswood, Australia
John Hunter Hospital
New Lambton Heights, Australia
Royal Darwin Hospital
Tiwi, Australia
Sint-Jan Hospital
Bruges, Belgium
Ziekenhuis Oost-Limburg
Genk, Belgium
University Hospital of Brussels
Jette, Belgium
Frisius Medical Center
Leeuwarden, Netherlands
Radboud University Medical Center
Nijmegen, Netherlands
Auckland City Hospital
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Dunedin Hospital
Dunedin, New Zealand
Institute of Cardiovascular Diseases
Kamenitz, Serbia
Hospital Germans Trias
Barcelona, Spain
University Hospital of Navarra
Pamplona, Spain
University Hospital of North Durham
Durham, County Durham, United Kingdom
Glan Clwyd Hospital
Bodelwyddan, Denbighshire, United Kingdom
Dorset County Hospital
Dorchester, Dorset, United Kingdom
Basingstoke and North Hampshire Hospital
Basingstoke, Hampshire, United Kingdom
University Hospitals Leicester, Glenfield
Leicester, Leicestershire, United Kingdom
Royal Liverpool Hospital
Liverpool, Merseyside, United Kingdom
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom
Scunthorpe General Hospital
Scunthorpe, North Lincolnshire, United Kingdom
Kettering General Hospital
Kettering, Northamptonshire, United Kingdom
Wansbeck General Hospital
Ashington, Northumberland, United Kingdom
Raigmore Hospital
Inverness, Scotland, United Kingdom
Musgrove Park Hospital
Taunton, Somerset, United Kingdom
Morriston Hospital
Swansea, Wales, United Kingdom
Russells Hall Hospital
Dudley, West Midlands, United Kingdom
George Eliot Hospital
Nuneaton, West Midlands, United Kingdom
Walsall Manor Hospital
Walsall, West Midlands, United Kingdom
Sandwell General Hospital
West Bromwich, West Midlands, United Kingdom
Wycombe Hospital
High Wycombe, Wycombe, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
Aintree University Hospital
Aintree, United Kingdom
University Hospital Ayr
Ayr, United Kingdom
Barnsley Hospital NHS Foundation Trust
Barnsley, United Kingdom
Basildon University Hospital
Basildon, United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom
Blackpool Victoria Hospital
Blackpool, United Kingdom
Royal Sussex County Hospital
Brighton, United Kingdom
North Cumbria Integrated Care
Carlisle, United Kingdom
Chesterfield Royal Hospital
Chesterfield, United Kingdom
University Hospital Coventry & Warwickshire
Coventry, United Kingdom
County Durham and Darlington NHS Foundation Trust
Darlington, United Kingdom
Doncaster Royal Infirmary
Doncaster, United Kingdom
Ninewells Hospital
Dundee, United Kingdom
The Royal Infirmary of Edinburgh
Edinburgh, United Kingdom
Royal Devon & Exeter Hospital
Exeter, United Kingdom
Gateshead Health NHS Foundation Trust
Gateshead, United Kingdom
Golden Jubilee National Hospital
Glasgow, United Kingdom
Glasgow Royal Infirmary
Glasgow, United Kingdom
Queen Elizabeth University Hospital
Glasgow, United Kingdom
Gloucestershire Hospitals NHS Foundation
Gloucester, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, United Kingdom
West Middlesex University Hospital
Isleworth, United Kingdom
Airedale General Hospital
Keighley, United Kingdom
University Hospital Crosshouse
Kilmarnock, United Kingdom
Leeds General Infirmary
Leeds, United Kingdom
Lincoln County Hospital
Lincoln, United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, United Kingdom
Royal Liverpool Hospital
Liverpool, United Kingdom
St Bartholomew's Hospital
London, United Kingdom
St Thomas' Hospital
London, United Kingdom
University Hospital Lewisham
London, United Kingdom
Chelsea and Westminster Hospital
London, United Kingdom
St George's Hospital
London, United Kingdom
Cleveland Clinic London Hospital
London, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
Maidstone & Tunbridge Wells Hospital
Maidstone, United Kingdom
Wythenshawe Hospital
Manchester, United Kingdom
North Manchester General Hospital
Manchester, United Kingdom
The James Cook University Hospital
Middlesbrough, United Kingdom
Freeman Hospital
Newcastle upon Tyne, United Kingdom
Kings Mill Hospital
Nottingham, United Kingdom
Queens Medical Centre
Nottingham, United Kingdom
Royal Alexandra Hospital
Paisley, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Poole Hospital
Poole, United Kingdom
Queen Alexandra Hospital
Portsmouth, United Kingdom
Northern General Hospital
Sheffield, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
Forth Valley Royal Hospital
Stirling, United Kingdom
Stepping Hill Hospital
Stockport, United Kingdom
North Tees and Hartlepool NHS Foundation Trust
Stockton-on-Tees, United Kingdom
South Tyneside and Sunderland NHS Foundation Trust
Sunderland, United Kingdom
Torbay Hospital
Torquay, United Kingdom
Royal Cornwall Hospital
Truro, United Kingdom
Pinderfields Hospital
Wakefield, United Kingdom
South Warwickshire University NHS Foundation Trust
Warwick, United Kingdom
Watford General Hospital
Watford, United Kingdom
New Cross Hospital
Wolverhampton, United Kingdom
Worcester Acute Hospitals NHS FT
Worcester, United Kingdom
Yeovil District Hospital
Yeovil, United Kingdom