Main study characteristics of the ongoing randomised controlled trials
EASY-AS38 | EARLY TAVR39 | DANAVR40 | EVoLVeD41 | |
Identifier | NCT04204915 | NCT03042104 | NCT03972644 | NCT03094143 |
Estimated enrolment | 2844 participants | 900 participants | 1700 participants | 1000 participants |
Estimated completion date | October 2029 | March 2024 | September 2029 | October 2024 |
Intervention | AVR | TAVR | SAVR or TAVR | SAVR or TAVR (participants will be randomised based on the presence or absence of fibrosis on CMR) |
Primary outcomes | Cardiovascular death and hospitalisation for heart failure | All-cause death, all stroke and unplanned cardiovascular hospitalisation | All-cause mortality | All-cause mortality or unplanned aortic stenosis-related hospitalisation |
Key inclusion criteria |
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AS, aortic stenosis; AVR, aortic valve replacement; CMR, cardiac magnetic resonance; DANAVR, Danish National Randomized Study on Early Aortic Valve Replacement in Patients with Asymptomatic Severe Aortic Stenosis; EARLY-TAVR, Evaluation of TAVR Compared to Surveillance for Patients with Asymptomatic Severe Aortic Stenosis; EASY-AS, Early Valve Replacement in Severe Asymptomatic Aortic Stenosis Study; EVoLVeD, Early Valve Replacement Guided by Biomarkers of LV Decompensation in Asymptomatic Patients with Severe AS; LVEF, left ventricular ejection fraction; SAVR, surgical aortic valve replacement; STS, Society of Thoracic Surgeons; TAVR, transcatheter aortic valve replacement.