Brief summary

The objective of SCOPE I is to compare the performance of the ACURATE neo/TF to the SAPIEN 3 transcatheter aortic bioprosthesis with regard to early safety and clinical efficacy at 30 days.

The Secondary objectives is to compare the ACURATE neo/TF with the SAPIEN 3 aortic bioprosthesis with regard to secondary clinical and echocardiographic endpoints at 30 days, 1 year and 3 years

Primary endpoints

Modified* combined 30-day early safety and clinical efficacy endpoint as defined by VARC-2:

– All-cause mortality

– All stroke (disabling and non-disabling)

– Life-threatening or disabling bleeding

– Acute kidney injury (stage 2 or 3, including renal replacementtherapy)

– Coronary artery obstruction requiring intervention

– Major vascular complicationValve-related dysfunction requiringrepeat procedure (balloonaortic valvuloplasty, TAVI or SAVR in a separate intervention)

– Rehospitalization for valve-related symptoms or worsening congestive heart failure

– Valve-related dysfunction:

– Prosthetic aortic valve stenosis: mean aortic valve gradient ≥20 mmHg, effective orifice area (EOA) ≤ 1.1cm2 (if body surface area (BSA) ≥ 1.6cm2) or ≤ 0.9 cm2 (if BSA < 1.6cm2)and/or Doppler velocity index (DVI) < 0.35 (for LVOT>2.5cm: < 0.20) according to VARC-2 AND/OR

– Moderate or severe prosthetic valve regurgitation according to VARC-2

* “NYHA class III or IV” is omitted due to lack of objectiveness in its ascertainment

CERC Services

CEC eCRF / data-management,

CEC

Countries

Germany, Netherland, Switzerland, United Kingdom

Centers number

20 investigational centers