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. 2022 May 12;9(1):e001982. doi: 10.1136/openhrt-2022-001982

Table 4.

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
  • 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.