Current and planned randomised controlled trials investigating timing of aortic valve intervention
| Strategy | Proposed or ongoing trials | Population | Intervention | Primary outcome | Trial status/unique identifier | Country | Estimated completion |
| All-comers with asymptomatic severe AS | Aortic Valve Replacement Versus Conservative Treatment in Asymptomatic Severe Aortic Stenosis (AVATAR) | 312 patients with asymptomatic severe AS and STS score <8%. | SAVR or routine care. | All-cause mortality and MACE at 3 years. | Recruiting NCT02436655 | Serbia | 2020 |
| Early Surgery for Patients with Asymptomatic Aortic Stenosis (ESTIMATE) | 360 patients with asymptomatic severe AS, normal ETT and low surgical risk. | SAVR or routine care. | All-cause mortality and MACE at 1 year. | Recruiting NCT02627391 | France | 2019 | |
| Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients with AsYmptomatic Severe Aortic Stenosis (EARLY-TAVR) | 1109 patients aged >65 years with asymptomatic severe AS, trileaflet valve morphology and favourable ileofemoral arterial anatomy. | Transfemoral TAVI (Edwards SAPIEN 3) or routine care. | All-cause mortality, all stroke, and unplanned cardiovascular hospitalisation at 2 years. | Recruiting NCT03042104 | United States | 2021 | |
| Refined assessment of valve function – higher peak aortic-jet velocity threshold | Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis (RECOVERY) | 145 patients with very severe AS (Vmax >4.5 m/s, AVA <0.75 cm) and a negative ETT. | SAVR or routine care. | Cardiac mortality at 4 years. | Recruiting NCT01161732 | South Korea | 2022 |
| Assessment of myocardial decompensation – multiple biomarker assessment of left ventricular decompensation | Early Valve Replacement Guided by Biomarkers of Left Ventricular Decompensation in Asymptomatic Patients with Severe AS (EVoLVeD) | 400 patients with asymptomatic severe AS, normal LVEF and mid-wall fibrosis on cardiac MRI. | SAVR/TAVI or routine care. | All-cause mortality and unplanned AS-related hospitalisation at 3 years. | Recruiting NCT03094143 | UK | 2020 |
AS, aortic stenosis; ETT, exercise tolerance test; LVEF, left ventricular ejection fraction; MACE, major adverse cardiovascular events; SAVR, surgical aortic valve replacement; STS, Society of Thoracic Surgeons; TAVI, transcatheter aortic valve insertion.