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Early valve replacement for asymptomatic severe aortic stenosis

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

Not applicable Interventional University of Leicester · NCT04204915

This study is testing if getting an early heart valve replacement helps people with severe aortic stenosis who don’t have symptoms live healthier and avoid hospital visits compared to just waiting and watching.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment2844 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity of Leicester Academic / other
Locations110 sites (Garran, Australian Capital Territory and 109 other locations)
Trial IDNCT04204915 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate whether early aortic valve replacement (AVR) or transcatheter aortic valve implantation (TAVI) leads to better clinical outcomes compared to expectant management in patients with severe asymptomatic aortic stenosis (AS). The study will be conducted across multiple centers in the UK, Australia, and New Zealand, involving a randomized controlled design with up to 2844 participants. The primary focus is to assess the reduction in cardiovascular death and hospitalizations for heart failure as a result of early intervention. Participants will be carefully screened for eligibility based on specific clinical criteria and will be informed about the study's nature and risks before consenting.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old diagnosed with severe asymptomatic aortic stenosis who are deemed suitable for aortic valve replacement.

Not a fit: Patients with symptomatic aortic stenosis or those not suitable for aortic valve replacement may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved survival rates and quality of life for patients with severe asymptomatic aortic stenosis.

How similar studies have performed: Other studies have explored similar interventions in symptomatic patients, but this approach in asymptomatic patients is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Garran, Australian Capital Territory and 109 other locations

+60 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Aortic StenosisAsymptomatic aortic stenosisAortic valve replacementRandomised controlled trialExpectant managementHospitalisation for heart failureCardiovascular death
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.