Should you replace a heart valve before symptoms start? major trial aims to find out

NCT ID NCT04204915

Recruiting now Disease control Sponsor: University of Leicester Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jul 22, 2026 · Updated 3 times

Summary

This study compares two approaches for people with severe aortic stenosis who have no symptoms: early valve replacement (surgery or TAVI) versus watchful waiting. About 2,844 participants will be followed for at least 3 years to see which strategy reduces heart-related death and hospitalizations. The goal is to settle a long-standing debate in heart care.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Aortic valve replacement (surgery or TAVI)
What this could lead to: If successful, this could show that early valve replacement prevents heart failure and death in people with severe aortic stenosis who feel fine.
What could go wrong: This is a large trial but results are years away. Early surgery carries risks like infection or stroke, and it may not prove better than waiting.

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

AORTIC STENOSIS

Contacts and locations

Locations

Aberdeen Royal Infirmary
RECRUITING

Aberdeen, AB25 2ZN, United Kingdom
Aintree University Hospital
RECRUITING

Aintree, L9 7AL, United Kingdom
Airedale General Hospital
RECRUITING

Keighley, BD20 6TD, United Kingdom
Auckland City Hospital
RECRUITING

Auckland, 1023, New Zealand
Barnsley Hospital NHS Foundation Trust
RECRUITING

Barnsley, United Kingdom
Basildon University Hospital
RECRUITING

Basildon, SS16 5NL, United Kingdom
Basingstoke and North Hampshire Hospital
RECRUITING

Basingstoke, Hampshire, RG24 9NA, United Kingdom
Blackpool Victoria Hospital
RECRUITING

Blackpool, FY3 8NR, United Kingdom
Canberra Hospital
RECRUITING

Garran, Australian Capital Territory, 2605, Australia
Chelsea and Westminster Hospital
RECRUITING

London, SW10 9NH, United Kingdom
Chesterfield Royal Hospital
RECRUITING

Chesterfield, S44 5BL, United Kingdom
Christchurch Hospital
RECRUITING

Christchurch, 8011, New Zealand
Cleveland Clinic London Hospital
RECRUITING

London, SW1X 7HY, United Kingdom
County Durham and Darlington NHS Foundation Trust
RECRUITING

Darlington, DL3 6HX, United Kingdom
Derriford Hospital
RECRUITING

Plymouth, PL6 8DH, United Kingdom
Doncaster Royal Infirmary
RECRUITING

Doncaster, DN2 5LT, United Kingdom
Dorset County Hospital
WITHDRAWN

Dorchester, Dorset, DT1 2JY, United Kingdom
Dunedin Hospital
RECRUITING

Dunedin, 9016, New Zealand
Fiona Stanley Hospital
RECRUITING

Perth, Western Australia, 6150, Australia
Flinders Medical Centre
RECRUITING

Adelaide, South Australia, SA 5042, Australia
Forth Valley Royal Hospital
RECRUITING

Stirling, FK9 4SW, United Kingdom
Freeman Hospital
RECRUITING

Newcastle upon Tyne, NE7 7DN, United Kingdom
Frisius Medical Center
RECRUITING

Leeuwarden, Netherlands
Gateshead Health NHS Foundation Trust
RECRUITING

Gateshead, NE9 6SX, United Kingdom
George Eliot Hospital
RECRUITING

Nuneaton, West Midlands, CV10 7DJ, United Kingdom
Glan Clwyd Hospital
RECRUITING

Bodelwyddan, Denbighshire, LL18 5UJ, United Kingdom
Glasgow Royal Infirmary
RECRUITING

Glasgow, United Kingdom
Gloucestershire Hospitals NHS Foundation
RECRUITING

Gloucester, United Kingdom
Golden Jubilee National Hospital
RECRUITING

Glasgow, G81 4DY, United Kingdom
Hospital Germans Trias
RECRUITING

Barcelona, Spain
Huddersfield Royal Infirmary
RECRUITING

Huddersfield, HD3 3EA, United Kingdom
Imperial College Healthcare NHS Trust
RECRUITING

London, United Kingdom
Institute of Cardiovascular Diseases
RECRUITING

Kamenitz, 21204, Serbia
John Hunter Hospital
RECRUITING

New Lambton Heights, NSW 2305, Australia
Kettering General Hospital
RECRUITING

Kettering, Northamptonshire, NN16 8UZ, United Kingdom
Kings Mill Hospital
RECRUITING

Nottingham, NG17 4JL, United Kingdom
Leeds General Infirmary
RECRUITING

Leeds, LS1 3EX, United Kingdom
Lincoln County Hospital
RECRUITING

Lincoln, LN2 5QY, United Kingdom
Liverpool Heart and Chest Hospital
RECRUITING

Liverpool, L14 3PE, United Kingdom
Liverpool Hospital
RECRUITING

Liverpool, New South Wales, 2170, Australia
Lyell McEwin Hospital
RECRUITING

Elizabeth Vale, SA 5112, Australia
Maidstone & Tunbridge Wells Hospital
RECRUITING

Maidstone, ME16 9QQ, United Kingdom
Monash Health
RECRUITING

Clayton, Victoria, 3168, Australia
Morriston Hospital
RECRUITING

Swansea, Wales, SA6 6NL, United Kingdom
Musgrove Park Hospital
RECRUITING

Taunton, Somerset, TA1 5DA, United Kingdom
Nepean Hospital
RECRUITING

Kingswood, NSW 2747, Australia
New Cross Hospital
RECRUITING

Wolverhampton, United Kingdom
Ninewells Hospital
RECRUITING

Dundee, United Kingdom
Norfolk and Norwich University Hospital
RECRUITING

Norwich, Norfolk, NR4 7UY, United Kingdom
North Cumbria Integrated Care
RECRUITING

Carlisle, CA2 7AF, United Kingdom
North Manchester General Hospital
RECRUITING

Manchester, M8 5RB, United Kingdom
North Tees and Hartlepool NHS Foundation Trust
RECRUITING

Stockton-on-Tees, TS19 8PE, United Kingdom
Northern General Hospital
RECRUITING

Sheffield, S5 7AU, United Kingdom
Northern Hospital
RECRUITING

Epping, VIC 3076, Australia
Pinderfields Hospital
RECRUITING

Wakefield, WF1 4DG, United Kingdom
Poole Hospital
RECRUITING

Poole, BH15 2JB, United Kingdom
Prince Charles Hospital
RECRUITING

Chermside, Queensland, 4032, Australia
Queen Alexandra Hospital
RECRUITING

Portsmouth, PO6 3LY, United Kingdom
Queen Elizabeth Hospital
RECRUITING

Birmingham, B15 2GW, United Kingdom
Queen Elizabeth University Hospital
RECRUITING

Glasgow, United Kingdom
Queens Medical Centre
RECRUITING

Nottingham, NG7 2UH, United Kingdom
Radboud University Medical Center
RECRUITING

Nijmegen, Netherlands
Raigmore Hospital
RECRUITING

Inverness, Scotland, IV2 3UJ, United Kingdom
Royal Adelaide Hospital
RECRUITING

Adelaide, South Australia, 5000, Australia
Royal Alexandra Hospital
RECRUITING

Paisley, PA2 9PN, United Kingdom
Royal Cornwall Hospital
RECRUITING

Truro, TR1 3LJ, United Kingdom
Royal Darwin Hospital
RECRUITING

Tiwi, TIWI NT 0810, Australia
Royal Devon & Exeter Hospital
RECRUITING

Exeter, EX2 5DW, United Kingdom
Royal Hobart Hospital
RECRUITING

Hobart, TAS 7000, Australia
Royal Liverpool Hospital
RECRUITING

Liverpool, Merseyside, L7 8YE, United Kingdom
Royal Liverpool Hospital
NOT_YET_RECRUITING

Liverpool, L7 8XP, United Kingdom
Royal North Shore Hospital
RECRUITING

St Leonards, New South Wales, 2065, Australia
Royal Perth Hospital
RECRUITING

Perth, Western Australia, WA6000, Australia
Royal Sussex County Hospital
RECRUITING

Brighton, BN2 5BE, United Kingdom
Russells Hall Hospital
RECRUITING

Dudley, West Midlands, DY1 2HQ, United Kingdom
Sandwell General Hospital
RECRUITING

West Bromwich, West Midlands, B71 4HJ, United Kingdom
Scunthorpe General Hospital
RECRUITING

Scunthorpe, North Lincolnshire, DN15 7BH, United Kingdom
Sint-Jan Hospital
RECRUITING

Bruges, Brugge, 8000, Belgium
South Tyneside and Sunderland NHS Foundation Trust
RECRUITING

Sunderland, United Kingdom
South Warwickshire University NHS Foundation Trust
RECRUITING

Warwick, United Kingdom
Southampton General Hospital
RECRUITING

Southampton, SO16 6YD, United Kingdom
St Bartholomew's Hospital
RECRUITING

London, EC1A 7BE, United Kingdom
St George's Hospital
RECRUITING

London, SW17 0QT, United Kingdom
St Thomas' Hospital
RECRUITING

London, SE1 7EH, United Kingdom
Stepping Hill Hospital
RECRUITING

Stockport, SK2 7JE, United Kingdom
The Gold Coast Hospital
RECRUITING

Southport, Queensland, 4215, Australia
The James Cook University Hospital
RECRUITING

Middlesbrough, TS4 3BW, United Kingdom
The Royal Infirmary of Edinburgh
RECRUITING

Edinburgh, EH16 4SA, United Kingdom
Torbay Hospital
RECRUITING

Torquay, TQ2 7AA, United Kingdom
Townsville Hospital
RECRUITING

Douglas, Queensland, 4814, Australia
University Hospital Ayr
RECRUITING

Ayr, KA6 6DX, United Kingdom
University Hospital Coventry & Warwickshire
RECRUITING

Coventry, CV2 2DX, United Kingdom
University Hospital Crosshouse
RECRUITING

Kilmarnock, KA2 0BE, United Kingdom
University Hospital Geelong
RECRUITING

Geelong, Victoria, 3220, Australia
University Hospital Lewisham
RECRUITING

London, SE13 6LH, United Kingdom
University Hospital of Brussels
RECRUITING

Jette, 1090, Belgium
University Hospital of Navarra
RECRUITING

Pamplona, Spain
University Hospital of North Durham
RECRUITING

Durham, County Durham, DH1 5TW, United Kingdom
University Hospitals Leicester, Glenfield
RECRUITING

Leicester, Leicestershire, LE3 9QP, United Kingdom
Walsall Manor Hospital
RECRUITING

Walsall, West Midlands, WS2 9PS, United Kingdom
Wansbeck General Hospital
RECRUITING

Ashington, Northumberland, NE63 9JJ, United Kingdom
Watford General Hospital
RECRUITING

Watford, WD18 0HB, United Kingdom
West Middlesex University Hospital
RECRUITING

Isleworth, TW7 6AF, United Kingdom
Westmead Hospital
RECRUITING

Westmead, New South Wales, 2145, Australia
Wollongong Hospital
RECRUITING

Wollongong, New South Wales, 2500, Australia
Worcester Acute Hospitals NHS FT
RECRUITING

Worcester, United Kingdom
Wycombe Hospital
RECRUITING

High Wycombe, Wycombe, HP11 2TT, United Kingdom
Wythenshawe Hospital
RECRUITING

Manchester, M23 9LT, United Kingdom
Yeovil District Hospital
WITHDRAWN

Yeovil, BA21 4AT, United Kingdom
Ziekenhuis Oost-Limburg
RECRUITING

Genk, 3600, Belgium

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