Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGINTERVENTIONAL

The Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis Study

A Randomised Controlled Trial of Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form 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 Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

PROCEDURE

Aortic valve replacement

Participants will be assessed by a member of the surgical team performing aortic valve replacement (AVR), and by any other relevant medical professionals identified by the doctors overseeing their care in hospital. When deemed ready for AVR, a member of the surgical team will ask for consent to proceed with the AVR. They will discuss the surgical procedure, covering information on the basic technical procedure, risks and expected recovery time.

Locations (20)

Canberra Hospital
Garran, Australian Capital Territory, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Wollongong Hospital
Wollongong, New South Wales, Australia
Prince Charles Hospital
Chermside, Queensland, Australia
Townsville Hospital
Douglas, Queensland, Australia
The Gold Coast Hospital
Southport, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Adelaide, South Australia, Australia
Monash Health
Clayton, Victoria, Australia
University Hospital Geelong
Geelong, Victoria, Australia
Fiona Stanley Hospital
Perth, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Lyell McEwin Hospital
Elizabeth Vale, Australia
Northern Hospital
Epping, Australia
Royal Hobart Hospital
Hobart, Australia
Nepean Hospital
Kingswood, Australia
John Hunter Hospital
New Lambton Heights, Australia
Royal Darwin Hospital
Tiwi, Australia