The Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis Study (EASY-AS)
Aortic Stenosis
About this trial
This is an interventional prevention trial for Aortic Stenosis focused on measuring Asymptomatic aortic stenosis, Aortic valve replacement, Randomised controlled trial, Expectant management, Hospitalisation for heart failure, Cardiovascular death
Eligibility Criteria
Inclusion Criteria:
- 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 written English or availability of a translator to explain the study documentation
Exclusion Criteria:
- Symptoms related to AS
- Additional severe valvular heart disease
- Other cardiac surgery planned pre-randomisation (eg CABG)
- Left ventricular systolic dysfunction (LVEF <50%)
- Pregnancy
- Co-morbid condition that, in the opinion of the treating cardiologist, limits life expectancy to <2 years
- Patient has previously undergone AVR or TAVI with restenosis
Sites / Locations
- Canberra HospitalRecruiting
- Liverpool HospitalRecruiting
- Royal North Shore HospitalRecruiting
- Westmead HospitalRecruiting
- Wollongong HospitalRecruiting
- Prince Charles HospitalRecruiting
- Townsville HospitalRecruiting
- The Gold Coast HospitalRecruiting
- Royal Adelaide HospitalRecruiting
- Flinders Medical CentreRecruiting
- Monash HealthRecruiting
- University Hospital GeelongRecruiting
- Fiona Stanley HospitalRecruiting
- Royal Perth HospitalRecruiting
- Lyell McEwin HospitalRecruiting
- Northern HospitalRecruiting
- Royal Hobart HospitalRecruiting
- Nepean HospitalRecruiting
- John Hunter HospitalRecruiting
- Royal Darwin HospitalRecruiting
- Auckland City HospitalRecruiting
- Christchurch HospitalRecruiting
- Dunedin HospitalRecruiting
- Institute of Cardiovascular DiseasesRecruiting
- University Hospital of North DurhamRecruiting
- Glan Clwyd HospitalRecruiting
- Dorset County HospitalRecruiting
- Basingstoke and North Hampshire HospitalRecruiting
- University Hospitals Leicester, GlenfieldRecruiting
- Royal Liverpool HospitalRecruiting
- Norfolk and Norwich University HospitalRecruiting
- Scunthorpe General HospitalRecruiting
- Kettering General HospitalRecruiting
- Wansbeck General HospitalRecruiting
- Raigmore HospitalRecruiting
- Musgrove Park HospitalRecruiting
- Morriston HospitalRecruiting
- Russells Hall HospitalRecruiting
- George Eliot HospitalRecruiting
- Walsall Manor HospitalRecruiting
- Sandwell General HospitalRecruiting
- Aberdeen Royal InfirmaryRecruiting
- Aintree University HospitalRecruiting
- Basildon University HospitalRecruiting
- Queen Elizabeth HospitalRecruiting
- Blackpool Victoria HospitalRecruiting
- Royal Sussex County HospitalRecruiting
- North Cumbria Integrated CareRecruiting
- County Durham and Darlington NHS Foundation TrustRecruiting
- Doncaster Royal InfirmaryRecruiting
- The Royal Infirmary of EdinburghRecruiting
- Royal Devon & Exeter HospitalRecruiting
- Huddersfield Royal InfirmaryRecruiting
- Airedale General HospitalRecruiting
- Leeds General InfirmaryRecruiting
- Lincoln County HospitalRecruiting
- Liverpool Heart and Chest HospitalRecruiting
- Royal Liverpool Hospital
- St Bartholomew's HospitalRecruiting
- St Thomas' HospitalRecruiting
- University Hospital LewishamRecruiting
- Imperial College Healthcare NHS TrustRecruiting
- Maidstone & Tunbridge Wells HospitalRecruiting
- Wythenshawe HospitalRecruiting
- North Manchester General HospitalRecruiting
- The James Cook University HospitalRecruiting
- Derriford HospitalRecruiting
- Poole HospitalRecruiting
- Queen Alexandra HospitalRecruiting
- Southampton General HospitalRecruiting
- North Tees and Hartlepool NHS Foundation TrustRecruiting
- Torbay HospitalRecruiting
- South Warwickshire University NHS Foundation TrustRecruiting
- Yeovil District HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
No Intervention
Group A: Aortic valve replacement
Group B: Expectant management
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 3 months, dependent on local hospitals' waiting lists.
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.