Aortic Stenosis narrowing of the aortic valve
Conditions
Interventions
 
The study will compare two clinical strategies: either early AVR (surgical or 
TAVI) or initial expectant management (with prompt AVR recommended if symptoms 
of AS develop). 
Sponsors
University of Leicester
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age >18 years 2. Patient has severe asymptomatic AS, in line with current international guidelines, defined as either: a) Peak velocity >=4m/s OR mean pressure gradient >=40mmHg WITH aortic valve area <=1.0cm2 OR <=0.6cm2/m2 body surface area OR b) 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 c) 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
Exclusion criteria: 1. Symptoms related to AS 2. Additional severe valvular heart disease 3. Other cardiac surgery planned pre-randomisation (eg CABG) 4. Left ventricular systolic dysfunction (LVEF <50%) 5. Pregnancy 6. Co-morbid condition that, in the opinion of the treating cardiologist, limits life expectancy to <2 years 7. Patient has previously undergone AVR or TAVI with restenosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A combined measure of CV death and HHF, measured in days from randomisation until end of trial (minimum 3 years). The primary analysis will be undertaken when 663 events have accrued, which is estimated to be after a median of 5 years follow-up assuming 2844 patients are recruited over 4 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Disability-free survival (WHODAS) • Number of days alive and out of hospital • Number of major adverse events including: death (cardiovascular, including sudden cardiac death, and non-cardiovascular), hospitalisation for heart failure, myocardial infarction, stroke • Additional outcomes of special interest: infective endocarditis and major bleeding, resuscitated cardiac arrest, hospitalisation with new onset atrial fibrillation, syncope, revascularization (CABG/PCI), cardiac device implantation (permanent pacemaker or implantable cardioverter defibrillator) • Quality of life measured by the EQ-5D-5L questionnaire | — |
Countries
Australia, Netherlands, New Zealand, United Kingdom
Contacts
Public ContactM. Wal
Frisius Medisch Centrum
Outcome results
None listed