Early valve replacement for asymptomatic severe aortic stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Canberra Hospital
  Garran, Australian Capital Territory, Australia Recruiting
• Liverpool Hospital
  Liverpool, New South Wales, Australia Recruiting
• Royal North Shore Hospital
  St Leonards, New South Wales, Australia Recruiting
• Westmead Hospital
  Westmead, New South Wales, Australia Recruiting
• Wollongong Hospital
  Wollongong, New South Wales, Australia Recruiting
• Prince Charles Hospital
  Chermside, Queensland, Australia Recruiting

+60 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Gerry McCann, Prof — University of Leicester
• Study coordinator: Carla Richardson
• Email: easyas@leicester.ac.uk
• Phone: +44 0116-229-7936

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.