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Taking people in SerbiaNo phase

Tests early valve replacement in people with severe aortic stenosis but no symptoms

Compares early aortic valve replacement with regular monitoring in adults with severe, symptom-free aortic stenosis.

Key facts

Who runs it
University of Leicester
Where
Kamenitz, SerbiaSee the siteAlso in 6 other countries, 108 sites
Trial code
Registry title
The Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis Study
Status
Recruiting
People taking part
2,104 people, planned
Started
10 Mar 2020
Expected to end
1 Apr 2031
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Aortic valve replacement
Record updated
21 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with severe aortic stenosis (a narrowed heart valve) who have no symptoms. It compares early valve replacement with regular check-ups.

Age
Over 18 years.
Sex
All sexes can join.
Disease stage
Severe aortic stenosis without symptoms, shown by heart ultrasound measurements (peak velocity, pressure gradient, valve area) and, in some cases, a high calcium score.
Earlier treatment
No earlier aortic valve replacement (surgery or TAVI) with re-narrowing of the valve.
Biomarker or test result
Valve measurements: peak velocity ≥4m/s or mean pressure gradient ≥40mmHg, with a small valve area. Some people join with 3.5m/s - 3.9m/s plus a high calcium score (>1200 for females, >2000 for males).

Main reasons for not taking part

  • Symptoms caused by the aortic stenosis
  • Another severe heart valve disease
  • Other heart surgery planned before randomisation (for example CABG)
  • Weak heart pumping function (LVEF <50%)
  • Pregnancy

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • Age >18 years
  • Patient has severe asymptomatic AS, in line with current international guidelines, defined as either:; Peak velocity ≥4m/s OR mean pressure gradient ≥40mmHg WITH aortic valve area ≤1.0cm2 OR ≤0.6cm2/m2 body surface area OR; 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; 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
  • The responsible clinician feels that either ongoing surveillance or early AVR are appropriate
  • Regarded by the treating cardiologist to be suitable for AVR (surgical or TAVI) with an acceptable risk
  • Willing to provide informed consent and be randomised to early AVR or expectant management
  • 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

Who cannot take part

  • Patient has previously undergone AVR or TAVI with restenosis
  • Additional severe valvular heart disease
  • Other cardiac surgery planned pre-randomisation (eg CABG)
  • Left ventricular systolic dysfunction (LVEF <50%)
  • Co-morbid condition that, in the opinion of the treating cardiologist, limits life expectancy to <2 years
  • Symptoms related to AS
  • Pregnancy

Where in Serbia

Also in 6 other countries, 108 sites

  • Institute of Cardiovascular DiseasesKamenitz, SerbiaContact: Lazar VelickiTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Group A: Aortic valve replacementExisting treatment, for comparison

    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 6 months, dependent on local hospitals' waiting lists.

    Treatment: Aortic valve replacement

  • Group B: Expectant managementNo study treatment, for comparison

    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.

Results explained

A paper that names this trial, explained in plain words.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Randomised Controlled Trial of Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis
Plain-language title
Tests early valve replacement in people with severe aortic stenosis but no symptomsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Publications
Record updated
21 July 2026