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

NCT ID NCT04204915

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 2,104 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2020

Expected to finish

Apr 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age \>18 years 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: 7. Symptoms related to AS 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

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    108 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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 &amp; 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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