Status:
RECRUITING
The Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis Study
Lead Sponsor:
University of Leicester
Collaborating Sponsors:
University of Auckland, New Zealand
University Hospitals, Leicester
Conditions:
Aortic Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 p...
Detailed Description
This is a major pragmatic multi-centre prospective parallel group open RCT. It will be conducted in the UK, Australia and New Zealand, funding is being sought in several countries to expand recruitmen...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2031
Estimated Enrollment :
2844 Patients enrolled
Trial Details
Trial ID
NCT04204915
Start Date
March 10 2020
End Date
April 1 2031
Last Update
September 25 2025
Active Locations (110)
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1
Canberra Hospital
Garran, Australian Capital Territory, Australia, 2605
2
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
3
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
4
Westmead Hospital
Westmead, New South Wales, Australia, 2145