The Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis Study
NCT ID: NCT04204915
Last Updated: 2025-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2844 participants
INTERVENTIONAL
2020-03-10
2031-04-01
Brief Summary
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Detailed Description
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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 2844 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 3 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group A: Aortic valve replacement
Participants randomised to AVR will be investigated and managed according to local protocols and standard practice. Participants will be placed on the waiting list with the aim that surgery will be performed within 3 months, dependent on local hospitals' waiting lists.
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.
Group B: Expectant management
Participants randomised to expectant management will continue to have regular monitoring of their condition in line with the procedures and standard practices of their hospital.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Patient has severe asymptomatic AS, in line with current international guidelines, defined as either:
1. Peak velocity ≥4m/s OR mean pressure gradient ≥40mmHg WITH aortic valve area ≤1.0cm2 OR ≤0.6cm2/m2 body surface area OR
2. Peak velocity ≥4m/s OR mean pressure gradient ≥40mmHg WITH aortic valve area \>1.0 - ≤1.2cm2 OR \>0.6 - ≤0.7cm2/m2 body surface area AND high sex specific calcium score\* OR
3. Peak Velocity ≥3.5m/s - 3.9m/s AND mean pressure gradient \<40 mmHg WITH aortic valve area ≤1.0cm2 OR ≤0.6cm2/m2 body surface area AND high sex specific calcium score\* \*Sex specific high calcium scores (Agatston units): \>1200 females; \>2000 males
3. The responsible clinician feels that either ongoing surveillance or early AVR are appropriate.
4. Regarded by the treating cardiologist to be suitable for AVR (surgical or TAVI) with an acceptable risk
5. Willing to provide informed consent and be randomised to early AVR or expectant management
6. An ability to understand one of the written languages that the study has provided written and visual materials in, or the availability of a translator to explain the study documentation
Exclusion Criteria
8. Additional severe valvular heart disease
9. Other cardiac surgery planned pre-randomisation (eg CABG)
10. Left ventricular systolic dysfunction (LVEF \<50%)
11. Pregnancy
12. Co-morbid condition that, in the opinion of the treating cardiologist, limits life expectancy to \<2 years
13. Patient has previously undergone AVR or TAVI with restenosis
18 Years
ALL
No
Sponsors
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University of Auckland, New Zealand
OTHER
University Hospitals, Leicester
OTHER
The University of Western Australia
OTHER
University of Leicester
OTHER
Responsible Party
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Principal Investigators
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Gerry McCann, Prof
Role: PRINCIPAL_INVESTIGATOR
University of Leicester
Graham Hillis, Prof
Role: PRINCIPAL_INVESTIGATOR
The University of Western Australia
Ralph Stewart, Prof
Role: PRINCIPAL_INVESTIGATOR
University of Aukland
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Professor Walter Abhayaratna
Role: primary
Professor Dominic Leung
Role: primary
Professor Ravinay Bhindi
Role: primary
Dr Dylan Wynne
Role: primary
Dr Edward Danson
Role: primary
Dale Murdoch
Role: primary
Dr Lim Eng
Role: primary
Dr Kuljit Singh
Role: primary
Dr Jerrett Lau
Role: primary
Professor Joseph Selvanayagam
Role: primary
Professor Julian Smith
Role: primary
A/Professor John Amerena
Role: primary
Dr Gerald Yong
Role: primary
Professor Graham Hillis
Role: primary
Dr Luan Huynh
Role: primary
Dr Chiew Wong
Role: primary
Dr Ashutosh Hardikar
Role: primary
Professor Kaz Negishi
Role: primary
A/Professor Aaron Sverdlov
Role: primary
Dr Hussam Tayeb
Role: primary
Dr Philippe Debonnaire
Role: primary
Dr Philippe Bertrand
Role: primary
Dr Xavier Galloo
Role: primary
Olga Bondarenko
Role: primary
Saloua ElMessaoudi
Role: primary
Professor Ralph Stewart
Role: primary
Dr Philip Adamson
Role: primary
Dr Sean Coffey
Role: primary
Lazar Velicki
Role: primary
Dr Victoria Delgado
Role: primary
Rafael Sadaba
Role: primary
Darragh Twomey
Role: primary
Satheesh Nair
Role: primary
Dr Jason Glover
Role: primary
Dr Anvesha Singh
Role: primary
Prathap Kanagala
Role: primary
Dr Vassilios Vassiliou
Role: primary
Rashed Hossain
Role: primary
Dr Kai Hogrefe
Role: primary
Dr David Ripley
Role: primary
Stephen Leslie
Role: primary
Thomas Rees
Role: primary
Alexander Chase
Role: primary
Craig Barr
Role: primary
Suresh Krishnamoorthy
Role: primary
Rumi Jaumdally
Role: primary
Abdul Maher
Role: primary
Dr Piers Clifford
Role: primary
Dr Ciprian Dospinescu
Role: primary
Mr Hussein El-Shafei
Role: backup
Dr Prathap Kanagala
Role: primary
Dr Jim McGowan
Role: primary
Deoraj Zamfar
Role: primary
Dr Jason Dungu
Role: primary
Professor Rick Steeds
Role: primary
Professor Nidal Bittar
Role: primary
Dr David Hildick-Smith
Role: primary
Dr Rhidian Shelton
Role: primary
Dr Justin Cooke
Role: primary
Dr Luke Tapp
Role: primary
Dr Jamal Khan
Role: backup
Dr Darragh Twomey
Role: primary
Dr Gillian Payne
Role: primary
Chim Lang
Role: primary
Professor Marc Dweck
Role: primary
Professor David Newby
Role: backup
Dr Andrew Ludman
Role: primary
Dr Ashfaq Mohammed
Role: primary
Dr Nawwar Al-Attar
Role: primary
Dr Stuart Watkins
Role: primary
Fraser Graham
Role: primary
Val Nikolaidou
Role: primary
Dr Hossam El Mahy
Role: primary
Dr Gajen Sunthar Kanaganayagam
Role: primary
Dr Haqeel Jamil
Role: primary
Dr Angie Ghattas
Role: primary
Professor John Greenwood
Role: primary
Dr Kelvin Lee
Role: primary
Dr Timothy Fairbairn
Role: primary
Dr Prathap Kanagala
Role: primary
Dr Michael Fisher
Role: backup
Dr Thomas Treibel
Role: primary
Professor Ronak Rajani
Role: primary
Dr Amar Singh
Role: primary
Dr Gajen Sunthar Kanaganayagam
Role: primary
Dr Sami Firoozi
Role: primary
Dr Guy Llyod
Role: primary
Professor Jamil Mayet
Role: primary
Dr Timothy Williams
Role: primary
Dr Laura Dobson
Role: primary
Dr Laura Dobson
Role: primary
Dr Ahmed Adlan
Role: backup
Dr Jeet Thambyrajah
Role: primary
Professor Vijay Kunadian
Role: primary
Dr Thandar Aye
Role: primary
Dr Michael Sosin
Role: primary
Dr Stuart Hood
Role: primary
Dr Sivasankar Sangaraju
Role: primary
Mr Sanjay Asopa
Role: backup
Dr Chris Steadman
Role: primary
Dr Peter Haworth
Role: primary
Dr Muhhammad Aetesam-ur-Rahman
Role: primary
Professor Nick Curzen
Role: primary
Mr Sunil Ohri
Role: backup
Dr Christopher Gingles
Role: primary
Dr Rosica Panayotova
Role: primary
Dr Paul Davison
Role: primary
Samuel McClure
Role: primary
Dr Usman Sheikh
Role: primary
Dr Mohammed Abubakr
Role: primary
Dr Thomas Craven
Role: primary
Dr John Fryearson
Role: primary
Dr Piyush Jain
Role: primary
Sandeep Hothi
Role: primary
Ashiq Saffy
Role: primary
Other Identifiers
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CS/18/7/33714
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
266292
Identifier Type: OTHER
Identifier Source: secondary_id
90865
Identifier Type: OTHER
Identifier Source: secondary_id
0700
Identifier Type: OTHER
Identifier Source: secondary_id
0700
Identifier Type: -
Identifier Source: org_study_id
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