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More info
You can access this
clinical trial
if you have
Aortic Valve Stenosis
and you are
over 75
years old
-
The phase for this study is not defined.
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The purpose

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.

Provided treatments

  • Device: Symetis ACURATE neo/TF transfemoral TAVI system
  • Device: Edwards Sapien 3 Transcatheter Heart Valve

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT03011346. The sponsor of the trial is University Hospital Inselspital, Berne and it is looking for 739 volunteers for the current phase.
Official trial title:
Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis for Transcatheter Aortic Valve Implantation by Transfemoral Approach.