Transcatheter aortic valve implantation (TAVI) is an established treatment option for patients with severe symptomatic aortic stenosis and at increased risk for surgical aortic valve replacement (SAVR). Many novel devices are currently being developed and established transcatheter heart valves undergo design reiterations to address limitations and reduce complication rates associated with the device and implantation procedure. However, device comparisons by use of randomized trials are scarce in particular for newer generation transcatheter valves. The aim of this study is to assess non-inferiority of the self-expandable Symetis ACURATE neo/TF in comparison to the balloon-expandable Edwards SAPIEN 3 transcatheter aortic valve bioprosthesis with regard to early safety and clinical efficacy at 30 days.
ClinicalTrials.gov ID NCT03011346
Sponsor
Insel Gruppe AG, University Hospital Bern
Supported by
Study objectives
The primary objective is the comparison of the Symetis ACURATE neo/TF to the Edwards SAPIEN 3 transcatheter aortic bioprosthesis with regard to early safety and clinical efficacy at 30 days. Secondary objectives involve the comparison between the two devices 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
- Clinical Events Committee (CEC) activities
- CRF and Data management
Countries
Germany, Netherland, Switzerland, United Kingdom
Number of investigational sites
20
Number of patients
739
