Table 4

Main study characteristics of the ongoing randomised controlled trials

EASY-AS38EARLY TAVR39DANAVR40EVoLVeD41
IdentifierNCT04204915NCT03042104NCT03972644NCT03094143
Estimated enrolment2844 participants900 participants1700 participants1000 participants
Estimated completion dateOctober 2029March 2024September 2029October 2024
InterventionAVRTAVRSAVR or TAVRSAVR or TAVR
(participants will be randomised based on the presence or absence of fibrosis on CMR)
Primary outcomesCardiovascular death and hospitalisation for heart failureAll-cause death, all stroke and unplanned cardiovascular hospitalisationAll-cause mortalityAll-cause mortality or unplanned aortic stenosis-related hospitalisation
Key inclusion criteria
  • Asymptomatic severe AS.

  • Age >18 years.

  • LVEF ≥50%.

  • Asymptomatic severe AS.

  • Age ≥65 years.

  • LVEF ≥50%.

  • STS risk score <10.

  • Asymptomatic severe AS.

  • Age ≥18 and ≤85 years.

  • LVEF ≥50%.

  • Asymptomatic severe AS.

  • Age >18 years.

  • LVEF ≥50% on CMR.

  • 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.