ClinicaliQ Trial Snapshot
- The Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis Study — Recruiting • Non-phase study • Cardiology / Cardiovascular • NCT04204915.
- Testing early surgical aortic valve replacement in asymptomatic severe aortic stenosis patients versus the standard watchful waiting approach to determine whether proactive intervention improves outcomes before symptoms develop.
- Eligible patients are typically aged 55+ with severe aortic stenosis confirmed by echocardiography but without current symptoms, allowing evaluation of intervention timing in a population where management strategy remains clinically uncertain.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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. Increasingly clinicians face the dilemma of how to best manage this growing population of mainly elderly patients, many of whom are asymptomatic but have been identified as having severe AS, often as an incidental finding. Reduced aortic valve opening progresses over decades without any apparent symptoms…
Eligibility Snapshot
- : 1. Age >18 years
- 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 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.