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Study identifier: NCT04204915 Synced from ClinicalTrials.gov · August 03, 2026
● Recruiting

The Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis Study

Condition: Aortic Stenosis  ·  Sponsor: University of Leicester

PhaseNA
Planned participants2104
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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…

This description comes directly from the study's public registry record.

Talk to the study team

Carla Richardson  ·  +44 0116-229-7936  ·  easyas@leicester.ac.uk

Michael Walters  ·  easyas@leicester.ac.uk

Always discuss trial participation with your own doctor first.

Locations (110)

Canberra HospitalGarran, Australian Capital Territory, AustraliaRecruiting
Liverpool HospitalLiverpool, New South Wales, AustraliaRecruiting
Royal North Shore HospitalSt Leonards, New South Wales, AustraliaRecruiting
Westmead HospitalWestmead, New South Wales, AustraliaRecruiting
Wollongong HospitalWollongong, New South Wales, AustraliaRecruiting
Prince Charles HospitalChermside, Queensland, AustraliaRecruiting
Townsville HospitalDouglas, Queensland, AustraliaRecruiting
The Gold Coast HospitalSouthport, Queensland, AustraliaRecruiting
Royal Adelaide HospitalAdelaide, South Australia, AustraliaRecruiting
Flinders Medical CentreAdelaide, South Australia, AustraliaRecruiting
Monash HealthClayton, Victoria, AustraliaRecruiting
University Hospital GeelongGeelong, Victoria, AustraliaRecruiting

+ 98 more locations — full list on the registry record.

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