CTU Bern (Clinical Trials Unit)

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.

For further reading:
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)32220-2/fulltext
and
https://www.tctmd.com/news/scope-i-acurate-neo-comes-short-severe-aortic-stenosis