Study for people with Heart Disease
Recruiting Not a phased study
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Canberra Hospital | Garran | ACT | Recruiting |
| Liverpool Hospital | Liverpool | NSW | Recruiting |
| Royal North Shore Hospital | St Leonards | NSW | Recruiting |
| Westmead Hospital | Westmead | NSW | Recruiting |
| Wollongong Hospital | Wollongong | NSW | Recruiting |
| Prince Charles Hospital | Chermside | QLD | Recruiting |
| Townsville Hospital | Douglas | QLD | Recruiting |
| The Gold Coast Hospital | Southport | QLD | Recruiting |
| Royal Adelaide Hospital | Adelaide | SA | Recruiting |
| Flinders Medical Centre | Adelaide | SA | Recruiting |
| Monash Health | Clayton | VIC | Recruiting |
| University Hospital Geelong | Geelong | VIC | Recruiting |
| Fiona Stanley Hospital | Perth | WA | Recruiting |
| Royal Perth Hospital | Perth | WA | Recruiting |
| Lyell McEwin Hospital | Elizabeth Vale | SA | Recruiting |
| Northern Hospital | Epping | VIC | Recruiting |
| Royal Hobart Hospital | Hobart | TAS | Recruiting |
| Nepean Hospital | Kingswood | NSW | Recruiting |
| John Hunter Hospital | New Lambton Heights | NSW | Recruiting |
| Royal Darwin Hospital | Tiwi | NT | Recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
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
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 21 July 2026.
- This page last checked by Voxsanity: 11 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.