At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Aortic valve replacement (procedure)
- How long the study runs
- Study runs about 133 months (dates as stated)
- About the drug or intervention
- Aortic valve replacement — procedure: 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.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at severe aortic stenosis (a narrowing of the heart's aortic valve) that is not causing symptoms. It compares having an early aortic valve replacement (AVR) with waiting and being monitored instead.
Who can take part
- Adults over 18
- Severe aortic stenosis with no symptoms, based on specific heart scan measurements set out in international guidelines
- The responsible clinician believes both waiting with check-ups and early valve replacement are suitable options
- Considered suitable for valve replacement (surgery or TAVI, a keyhole valve procedure) with an acceptable risk
- Willing to give informed consent and be randomly placed into either the early valve replacement group or the monitoring group
- Able to understand one of the written languages used in the study materials, or has a translator available
Who may not be able to
- Symptoms caused by the aortic stenosis
- Other severe valve disease
- Other heart surgery already planned (for example coronary artery bypass grafting, CABG)
- Weakened heart pumping (left ventricular ejection fraction, LVEF, below 50%)
- Pregnancy
- Another health condition expected to limit life expectancy to under 2 years
- Previous aortic valve replacement or TAVI with re-narrowing of the valve
What taking part involves
- • Being randomly allocated to either early aortic valve replacement (surgery or TAVI) or expectant management (ongoing monitoring)
- • Not stated — ask the trial team
Time commitment: Number of visits and study duration: Not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 2,104
- Started
- 2020-03-10
- Last checked
- 2025-09
Plain English Summary
What is this study?
- • Testing a new treatment for aortic stenosis
- • NA - 2,104 participants
- • Aortic stenosis (AS) affects approximately 5% of individuals \>65 years old, with \~3% of people \>75 years having moderate to severe disease
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with aortic stenosis
Where?
- • Durham - University Hospital of North Durham
- • Bodelwyddan - Glan Clwyd Hospital
- • Dorchester - Dorset County Hospital
- • Basingstoke - Basingstoke and North Hampshire Hospital
- • +75 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
This is a major pragmatic multi-centre prospective parallel group open RCT. It will be conducted in the UK, Australia and New Zealand, funding is being sought in several countries to expand recruitment internationally. The study is in 2 phases: the vanguard and main phase. Therefore the study will run an internal pilot to prove recruitment of the relevant number of participants during the initial 2 years. The over-arching aim is to determine whether early AVR results in better clinical outcomes and cost-effectiveness than a strategy of expectant management in asymptomatic patients with severe AS. The primary hypothesis is that early AVR or TAVI in asymptomatic patients with severe AS will result in a reduction in the composite primary outcome of cardiovascular (CV) death and hospitalisation for heart failure (HHF) when compared to the conventional approach of expectant management. Potential participants will be identified by a member of the clinical care team following diagnosis with severe AS. Participants will be screened for eligibility using pre-specified inclusion/exclusion criteria. Eligible participants will be provided with a written version of the participant information sheet detailing the exact nature of the study, what it will involve for the participant and any risks involved with taking part. Participants will be given at least 24 hours to consider the information and decide whether or not to take part. The study will randomise up to 2104 patients with severe asymptomatic AS to either allocated expectant management OR aortic valve replacement. Participants randomised to AVR will be placed on a waiting list with the aim that surgery will be performed within 6 months, dependent on local hospitals' waiting lists. Participants randomised to AVR will undergo routine tests/procedures which may include coronary angiography. If the outcome of the coronary angiography reveals coronary heart disease, the decision to perform CABG or PCI will be made by the responsible cardiac surgeon and cardiologist, in consultation with the patient. All analyses will be undertaken using the principles of intention-to-treat with participants analysed in the group they were randomised regardless of treatment received. EASY-AS is collaborating with the EVoLVeD study (Early Valve Replacement guided by Biomarkers of Left Ventricular Decompensation in Asymptomatic Patients with Severe Aortic Stenosis, Clinical Trials.gov NCT03094143). In centres where both EASY-AS and EVoLVeD are running, participants in EASY-AS will be offered the opportunity to take part in EVoLVeD. Funding has been granted by the British Heart Foundation (UK), Medical Research Future Fund (Aus) and Heart Foundation (NZ). The UK sponsor is the University of Leicester. Additional support and resources for the study will be provided by the participating Trusts and their corresponding Clinical Research Networks in the UK. The central co-ordination centre is the University of Leicester Clinical Trials Unit.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Age \>18 years
- ✓Patient has severe not causing symptoms AS, in line with current international guidelines, defined as either:
- ✓Peak velocity ≥4m/s OR mean pressure gradient ≥40mmHg WITH aortic valve area ≤1.0cm2 OR ≤0.6cm2/m2 body surface area OR
- ✓The responsible clinician feels that either ongoing surveillance or early AVR are appropriate.
- ✓Regarded by the treating cardiologist to be suitable for AVR (surgical or TAVI) with an acceptable risk
Who cannot take part
- ✗Symptoms related to AS
- ✗Additional severe valvular heart disease
- ✗Other heart surgery planned pre-randomisation (eg CABG)
- ✗Left ventricular systolic dysfunction (LVEF \<50%)
- ✗Pregnancy
See the full criteria
Where Is This Study? (79 UK sites)
University Hospital of North Durham
Durham DH1 5TW, United Kingdom
Glan Clwyd Hospital
Bodelwyddan LL18 5UJ, United Kingdom
Dorset County Hospital
Dorchester DT1 2JY, United Kingdom
Anthony Homer. Research Governance Manager
Research@dchft.nhs.uk01305 253 127Basingstoke and North Hampshire Hospital
Basingstoke RG24 9NA, United Kingdom
University Hospitals Leicester, Glenfield
Leicester LE3 9QP, United Kingdom
Carolyn Maloney
uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351Royal Liverpool Hospital
Liverpool L7 8YE, United Kingdom
Norfolk and Norwich University Hospital
Norwich NR4 7UY, United Kingdom
Scunthorpe General Hospital
Scunthorpe DN15 7BH, United Kingdom
Kettering General Hospital
Kettering NN16 8UZ, United Kingdom
Research and Development
kgh-tr.researchkgh@nhs.net01536 492000 Ext 3942 / 3941Wansbeck General Hospital
Ashington NE63 9JJ, United Kingdom
Raigmore Hospital
Inverness IV2 3UJ, United Kingdom
Musgrove Park Hospital
Taunton TA1 5DA, United Kingdom
Morriston Hospital
Swansea SA6 6NL, United Kingdom
Russells Hall Hospital
Dudley DY1 2HQ, United Kingdom
George Eliot Hospital
Nuneaton CV10 7DJ, United Kingdom
Walsall Manor Hospital
Walsall WS2 9PS, United Kingdom
Sandwell General Hospital
West Bromwich B71 4HJ, United Kingdom
Wycombe Hospital
High Wycombe HP11 2TT, United Kingdom
Aberdeen Royal Infirmary
Aberdeen AB25 2ZN, United Kingdom
Aintree University Hospital
Aintree L9 7AL, United Kingdom
University Hospital Ayr
Ayr KA6 6DX, United Kingdom
Barnsley Hospital NHS Foundation Trust
Barnsley, United Kingdom
Basildon University Hospital
Basildon SS16 5NL, United Kingdom
Queen Elizabeth Hospital
Birmingham B15 2GW, United Kingdom
Blackpool Victoria Hospital
Blackpool FY3 8NR, United Kingdom
Royal Sussex County Hospital
Brighton BN2 5BE, United Kingdom
North Cumbria Integrated Care
Carlisle CA2 7AF, United Kingdom
Research and Development Team research@ncic.nhs.uk
nencadmin@nihr.ac.uk01228 523444Chesterfield Royal Hospital
Chesterfield S44 5BL, United Kingdom
University Hospital Coventry & Warwickshire
Coventry CV2 2DX, United Kingdom
County Durham and Darlington NHS Foundation Trust
Darlington DL3 6HX, United Kingdom
Research and Development Team cdda-tr.Research@nhs.net
nencadmin@nihr.ac.uk01325 743366Doncaster Royal Infirmary
Doncaster DN2 5LT, United Kingdom
Ninewells Hospital
Dundee, United Kingdom
The Royal Infirmary of Edinburgh
Edinburgh EH16 4SA, United Kingdom
Royal Devon & Exeter Hospital
Exeter EX2 5DW, United Kingdom
Gateshead Health NHS Foundation Trust
Gateshead NE9 6SX, United Kingdom
Research and Development Team ghnt.researchanddevelopment@nhs.net
ghnt.researchanddevelopment@nhs.net0191 4820000Golden Jubilee National Hospital
Glasgow G81 4DY, United Kingdom
Glasgow Royal Infirmary
Glasgow, United Kingdom
Queen Elizabeth University Hospital
Glasgow, United Kingdom
Gloucestershire Hospitals NHS Foundation
Gloucester, United Kingdom
R&I Professional Services
ghn-tr.glos.riprofessionalservices@nhs.net033 422 5467Huddersfield Royal Infirmary
Huddersfield HD3 3EA, United Kingdom
West Middlesex University Hospital
Isleworth TW7 6AF, United Kingdom
Airedale General Hospital
Keighley BD20 6TD, United Kingdom
Mechele Couch-Upite
anhsft.researchanddevelopment@nhs.net01535 292278 / 01535 294655University Hospital Crosshouse
Kilmarnock KA2 0BE, United Kingdom
Leeds General Infirmary
Leeds LS1 3EX, United Kingdom
Lincoln County Hospital
Lincoln LN2 5QY, United Kingdom
Liverpool Heart and Chest Hospital
Liverpool L14 3PE, United Kingdom
Royal Liverpool Hospital
Liverpool L7 8XP, United Kingdom
St Bartholomew's Hospital
London EC1A 7BE, United Kingdom
St Thomas' Hospital
London SE1 7EH, United Kingdom
University Hospital Lewisham
London SE13 6LH, United Kingdom
Chelsea and Westminster Hospital
London SW10 9NH, United Kingdom
St George's Hospital
London SW17 0QT, United Kingdom
Cleveland Clinic London Hospital
London SW1X 7HY, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
Maidstone & Tunbridge Wells Hospital
Maidstone ME16 9QQ, United Kingdom
Denise Day / Julie Knowles
mtw-tr.researchgovernance@nhs.net01622 225627Wythenshawe Hospital
Manchester M23 9LT, United Kingdom
North Manchester General Hospital
Manchester M8 5RB, United Kingdom
The James Cook University Hospital
Middlesbrough TS4 3BW, United Kingdom
Freeman Hospital
Newcastle upon Tyne NE7 7DN, United Kingdom
Kings Mill Hospital
Nottingham NG17 4JL, United Kingdom
Queens Medical Centre
Nottingham NG7 2UH, United Kingdom
Royal Alexandra Hospital
Paisley PA2 9PN, United Kingdom
Derriford Hospital
Plymouth PL6 8DH, United Kingdom
Poole Hospital
Poole BH15 2JB, United Kingdom
Queen Alexandra Hospital
Portsmouth PO6 3LY, United Kingdom
Northern General Hospital
Sheffield S5 7AU, United Kingdom
Southampton General Hospital
Southampton SO16 6YD, United Kingdom
Forth Valley Royal Hospital
Stirling FK9 4SW, United Kingdom
Stepping Hill Hospital
Stockport SK2 7JE, United Kingdom
Research, Development & Innovation Office
research.development@stockport.nhs.uk0161 419 5893North Tees and Hartlepool NHS Foundation Trust
Stockton-on-Tees TS19 8PE, United Kingdom
Research and Development
nth-tr.ntandh.researchdevelopment@nhs.net01642 624090South Tyneside and Sunderland NHS Foundation Trust
Sunderland, United Kingdom
Research and Development stsft.research@nhs.net
stsft.research@nhs.net0191 565 6256 ext 42143Torbay Hospital
Torquay TQ2 7AA, United Kingdom
Royal Cornwall Hospital
Truro TR1 3LJ, United Kingdom
Pinderfields Hospital
Wakefield WF1 4DG, United Kingdom
South Warwickshire University NHS Foundation Trust
Warwick, United Kingdom
Watford General Hospital
Watford WD18 0HB, United Kingdom
New Cross Hospital
Wolverhampton, United Kingdom
Worcester Acute Hospitals NHS FT
Worcester, United Kingdom
Yeovil District Hospital
Yeovil BA21 4AT, United Kingdom
How to Get in Touch
Carla Richardson
Sponsor contactCONTACT
Michael Walters
Sponsor contactCONTACT