Actively Recruiting
The Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis Study
Led by University of Leicester · Updated on 2025-09-25
2844
Participants Needed
110
Research Sites
577 weeks
Total Duration
On this page
Sponsors
U
University of Leicester
Lead Sponsor
U
University of Auckland, New Zealand
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Severe asymptomatic aortic stenosis as defined by specific valve measurements and calcium scores
- Treating cardiologist agrees that either ongoing surveillance or early AVR is appropriate
- Suitable for aortic valve replacement (surgical or TAVI) with acceptable risk
- Willing to provide informed consent and be randomized to early AVR or expectant management
- Ability to understand study materials or have access to a translator
You will not qualify if you...
- Symptoms related to aortic stenosis
- Additional severe valvular heart disease
- Planned other cardiac surgery before randomization (e.g., CABG)
- Left ventricular systolic dysfunction with ejection fraction less than 50%
- Pregnancy
- Co-morbid condition limiting life expectancy to less than 2 years
- Previous aortic valve replacement or TAVI with restenosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 110 locations
1
Canberra Hospital
Garran, Australian Capital Territory, Australia, 2605
Actively Recruiting
2
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
Actively Recruiting
3
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Actively Recruiting
4
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
5
Wollongong Hospital
Wollongong, New South Wales, Australia, 2500
Actively Recruiting
6
Prince Charles Hospital
Chermside, Queensland, Australia, 4032
Actively Recruiting
7
Townsville Hospital
Douglas, Queensland, Australia, 4814
Actively Recruiting
8
The Gold Coast Hospital
Southport, Queensland, Australia, 4215
Actively Recruiting
9
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
10
Flinders Medical Centre
Adelaide, South Australia, Australia, SA 5042
Actively Recruiting
11
Monash Health
Clayton, Victoria, Australia, 3168
Actively Recruiting
12
University Hospital Geelong
Geelong, Victoria, Australia, 3220
Actively Recruiting
13
Fiona Stanley Hospital
Perth, Western Australia, Australia, 6150
Actively Recruiting
14
Royal Perth Hospital
Perth, Western Australia, Australia, WA6000
Actively Recruiting
15
Lyell McEwin Hospital
Elizabeth Vale, Australia, SA 5112
Actively Recruiting
16
Northern Hospital
Epping, Australia, VIC 3076
Actively Recruiting
17
Royal Hobart Hospital
Hobart, Australia, TAS 7000
Actively Recruiting
18
Nepean Hospital
Kingswood, Australia, NSW 2747
Actively Recruiting
19
John Hunter Hospital
New Lambton Heights, Australia, NSW 2305
Actively Recruiting
20
Royal Darwin Hospital
Tiwi, Australia, TIWI NT 0810
Actively Recruiting
21
Sint-Jan Hospital
Bruges, Belgium, 8000
Actively Recruiting
22
Ziekenhuis Oost-Limburg
Genk, Belgium, 3600
Actively Recruiting
23
University Hospital of Brussels
Jette, Belgium, 1090
Actively Recruiting
24
Frisius Medical Center
Leeuwarden, Netherlands
Actively Recruiting
25
Radboud University Medical Center
Nijmegen, Netherlands
Actively Recruiting
26
Auckland City Hospital
Auckland, New Zealand, 1023
Actively Recruiting
27
Christchurch Hospital
Christchurch, New Zealand, 8011
Actively Recruiting
28
Dunedin Hospital
Dunedin, New Zealand, 9016
Actively Recruiting
29
Institute of Cardiovascular Diseases
Kamenitz, Serbia, 21204
Actively Recruiting
30
Hospital Germans Trias
Barcelona, Spain
Actively Recruiting
31
University Hospital of Navarra
Pamplona, Spain
Actively Recruiting
32
University Hospital of North Durham
Durham, County Durham, United Kingdom, DH1 5TW
Actively Recruiting
33
Glan Clwyd Hospital
Bodelwyddan, Denbighshire, United Kingdom, LL18 5UJ
Actively Recruiting
34
Dorset County Hospital
Dorchester, Dorset, United Kingdom, DT1 2JY
Withdrawn
35
Basingstoke and North Hampshire Hospital
Basingstoke, Hampshire, United Kingdom, RG24 9NA
Actively Recruiting
36
University Hospitals Leicester, Glenfield
Leicester, Leicestershire, United Kingdom, LE3 9QP
Actively Recruiting
37
Royal Liverpool Hospital
Liverpool, Merseyside, United Kingdom, L7 8YE
Actively Recruiting
38
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom, NR4 7UY
Actively Recruiting
39
Scunthorpe General Hospital
Scunthorpe, North Lincolnshire, United Kingdom, DN15 7BH
Actively Recruiting
40
Kettering General Hospital
Kettering, Northamptonshire, United Kingdom, NN16 8UZ
Actively Recruiting
41
Wansbeck General Hospital
Ashington, Northumberland, United Kingdom, NE63 9JJ
Actively Recruiting
42
Raigmore Hospital
Inverness, Scotland, United Kingdom, IV2 3UJ
Actively Recruiting
43
Musgrove Park Hospital
Taunton, Somerset, United Kingdom, TA1 5DA
Actively Recruiting
44
Morriston Hospital
Swansea, Wales, United Kingdom, SA6 6NL
Actively Recruiting
45
Russells Hall Hospital
Dudley, West Midlands, United Kingdom, DY1 2HQ
Actively Recruiting
46
George Eliot Hospital
Nuneaton, West Midlands, United Kingdom, CV10 7DJ
Actively Recruiting
47
Walsall Manor Hospital
Walsall, West Midlands, United Kingdom, WS2 9PS
Actively Recruiting
48
Sandwell General Hospital
West Bromwich, West Midlands, United Kingdom, B71 4HJ
Actively Recruiting
49
Wycombe Hospital
High Wycombe, Wycombe, United Kingdom, HP11 2TT
Actively Recruiting
50
Aberdeen Royal Infirmary
Aberdeen, United Kingdom, AB25 2ZN
Actively Recruiting
51
Aintree University Hospital
Aintree, United Kingdom, L9 7AL
Actively Recruiting
52
University Hospital Ayr
Ayr, United Kingdom, KA6 6DX
Actively Recruiting
53
Barnsley Hospital NHS Foundation Trust
Barnsley, United Kingdom
Actively Recruiting
54
Basildon University Hospital
Basildon, United Kingdom, SS16 5NL
Actively Recruiting
55
Queen Elizabeth Hospital
Birmingham, United Kingdom, B15 2GW
Actively Recruiting
56
Blackpool Victoria Hospital
Blackpool, United Kingdom, FY3 8NR
Actively Recruiting
57
Royal Sussex County Hospital
Brighton, United Kingdom, BN2 5BE
Actively Recruiting
58
North Cumbria Integrated Care
Carlisle, United Kingdom, CA2 7AF
Actively Recruiting
59
Chesterfield Royal Hospital
Chesterfield, United Kingdom, S44 5BL
Actively Recruiting
60
University Hospital Coventry & Warwickshire
Coventry, United Kingdom, CV2 2DX
Actively Recruiting
61
County Durham and Darlington NHS Foundation Trust
Darlington, United Kingdom, DL3 6HX
Actively Recruiting
62
Doncaster Royal Infirmary
Doncaster, United Kingdom, DN2 5LT
Actively Recruiting
63
Ninewells Hospital
Dundee, United Kingdom
Actively Recruiting
64
The Royal Infirmary of Edinburgh
Edinburgh, United Kingdom, EH16 4SA
Actively Recruiting
65
Royal Devon & Exeter Hospital
Exeter, United Kingdom, EX2 5DW
Actively Recruiting
66
Gateshead Health NHS Foundation Trust
Gateshead, United Kingdom, NE9 6SX
Actively Recruiting
67
Golden Jubilee National Hospital
Glasgow, United Kingdom, G81 4DY
Actively Recruiting
68
Glasgow Royal Infirmary
Glasgow, United Kingdom
Actively Recruiting
69
Queen Elizabeth University Hospital
Glasgow, United Kingdom
Actively Recruiting
70
Gloucestershire Hospitals NHS Foundation
Gloucester, United Kingdom
Actively Recruiting
71
Huddersfield Royal Infirmary
Huddersfield, United Kingdom, HD3 3EA
Actively Recruiting
72
West Middlesex University Hospital
Isleworth, United Kingdom, TW7 6AF
Actively Recruiting
73
Airedale General Hospital
Keighley, United Kingdom, BD20 6TD
Actively Recruiting
74
University Hospital Crosshouse
Kilmarnock, United Kingdom, KA2 0BE
Actively Recruiting
75
Leeds General Infirmary
Leeds, United Kingdom, LS1 3EX
Actively Recruiting
76
Lincoln County Hospital
Lincoln, United Kingdom, LN2 5QY
Actively Recruiting
77
Liverpool Heart and Chest Hospital
Liverpool, United Kingdom, L14 3PE
Actively Recruiting
78
Royal Liverpool Hospital
Liverpool, United Kingdom, L7 8XP
Not Yet Recruiting
79
St Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
Actively Recruiting
80
St Thomas' Hospital
London, United Kingdom, SE1 7EH
Actively Recruiting
81
University Hospital Lewisham
London, United Kingdom, SE13 6LH
Actively Recruiting
82
Chelsea and Westminster Hospital
London, United Kingdom, SW10 9NH
Actively Recruiting
83
St George's Hospital
London, United Kingdom, SW17 0QT
Actively Recruiting
84
Cleveland Clinic London Hospital
London, United Kingdom, SW1X 7HY
Actively Recruiting
85
Imperial College Healthcare NHS Trust
London, United Kingdom
Actively Recruiting
86
Maidstone & Tunbridge Wells Hospital
Maidstone, United Kingdom, ME16 9QQ
Actively Recruiting
87
Wythenshawe Hospital
Manchester, United Kingdom, M23 9LT
Actively Recruiting
88
North Manchester General Hospital
Manchester, United Kingdom, M8 5RB
Actively Recruiting
89
The James Cook University Hospital
Middlesbrough, United Kingdom, TS4 3BW
Actively Recruiting
90
Freeman Hospital
Newcastle upon Tyne, United Kingdom, NE7 7DN
Actively Recruiting
91
Kings Mill Hospital
Nottingham, United Kingdom, NG17 4JL
Actively Recruiting
92
Queens Medical Centre
Nottingham, United Kingdom, NG7 2UH
Actively Recruiting
93
Royal Alexandra Hospital
Paisley, United Kingdom, PA2 9PN
Actively Recruiting
94
Derriford Hospital
Plymouth, United Kingdom, PL6 8DH
Actively Recruiting
95
Poole Hospital
Poole, United Kingdom, BH15 2JB
Actively Recruiting
96
Queen Alexandra Hospital
Portsmouth, United Kingdom, PO6 3LY
Actively Recruiting
97
Northern General Hospital
Sheffield, United Kingdom, S5 7AU
Actively Recruiting
98
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
99
Forth Valley Royal Hospital
Stirling, United Kingdom, FK9 4SW
Actively Recruiting
100
Stepping Hill Hospital
Stockport, United Kingdom, SK2 7JE
Actively Recruiting
101
North Tees and Hartlepool NHS Foundation Trust
Stockton-on-Tees, United Kingdom, TS19 8PE
Actively Recruiting
102
South Tyneside and Sunderland NHS Foundation Trust
Sunderland, United Kingdom
Actively Recruiting
103
Torbay Hospital
Torquay, United Kingdom, TQ2 7AA
Actively Recruiting
104
Royal Cornwall Hospital
Truro, United Kingdom, TR1 3LJ
Actively Recruiting
105
Pinderfields Hospital
Wakefield, United Kingdom, WF1 4DG
Actively Recruiting
106
South Warwickshire University NHS Foundation Trust
Warwick, United Kingdom
Actively Recruiting
107
Watford General Hospital
Watford, United Kingdom, WD18 0HB
Actively Recruiting
108
New Cross Hospital
Wolverhampton, United Kingdom
Actively Recruiting
109
Worcester Acute Hospitals NHS FT
Worcester, United Kingdom
Actively Recruiting
110
Yeovil District Hospital
Yeovil, United Kingdom, BA21 4AT
Withdrawn
Research Team
C
Carla Richardson
CONTACT
M
Michael Walters
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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