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New treatment option for Aortic Stenosis
Official title The Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis Study
ClinicalTrials.gov ID: NCT04204915
What this study is testing
- What it's testing
- 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 population and is projected to double in the next two decades.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Peak Velocity ≥3.5m/s - 3.9m/s AND mean pressure gradient \ 1200 females; \>2000 males
You likely can't join if
- 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
See the full eligibility 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 \ 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 assigned by chance 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Garran, Australian Capital Territory, Australia
- Liverpool, New South Wales, Australia
- St Leonards, New South Wales, Australia
- Westmead, New South Wales, Australia
- Wollongong, New South Wales, Australia
- Chermside, Queensland, Australia
- Douglas, Queensland, Australia
- Southport, Queensland, Australia
- Adelaide, South Australia, Australia
- Clayton, Victoria, Australia
- Geelong, Victoria, Australia
- Perth, Western Australia, Australia
- Elizabeth Vale, Australia
- Epping, Australia
- Hobart, Australia
- Kingswood, Australia
- New Lambton Heights, Australia
- Tiwi, Australia
- Bruges, Brugge, Belgium
- Genk, Belgium
+ 77 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Garran, Australian Capital Territory, Australia; Liverpool, New South Wales, Australia; St Leonards, New South Wales, Australia; Westmead, New South Wales, Australia; Wollongong, New South Wales, Australia; Chermside, Queensland, Australia and 91 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.