The SCOPE I trial was recently published in the Lancet
The SCOPE I trial was recently published in the Lancet, comparing 30 days outcomes of the self-expandable ACURATE neo transcatheter aortic valve replacement device versus the balloon-expandable EDWARDS SAPIEN 3 transcatheter aortic valve replacement device, using the transfemoral access route. Performing TAVR with the self-expanding ACURATE neo did not meet non-inferiority compared to the balloon-expandable SAPIEN 3 device in terms of the primary early safety outcome at 30 days (i.e. a combination of clinical outcomes and echocardiographic evaluation of the valves using a blinded core laboratory). Currently the one year follow-ups are conducted to see how the valves perform at longer follow-up. Another three years follow-up is also planned.