Prospective, multi-center, non-randomized interventional study to evaluate the safety, effectiveness and performance of the Venus-Vitae Transcatheter Heart Valve System in patients with severe aortic stenosis. 150 subjects will be enrolled in up to 20 sites in multiple countries/regions including...
The purpose of this study is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo2™ aortic bioprosthesis and the ACURATE neo2™ transfemoral delivery system, in the context of an observational investigator-initiated trial (IIT). There are no additional and/or...
This is a prospective, multicenter, exploratory single arm and controlled clinical investigation compared to recent historical results. This pre-CE marked trial is conducted in two countries (France and the UK) with 5 Investigation sites participate to the trial. The recruitment was finalized in...
Landmark Trial is a prospective, randomized, multinational, multicentric, open-label non-inferiority trial of approximately 768 subjects (384:384, Myval THV Series vs. Contemporary Valves) with severe symptomatic native aortic valve stenosis via transfemoral approach. ID: NCT04275726
All Women study is a unique newly launching randomized controlled trial targeting female population older than 75 years old with symptomatic aortic stenosis. The objective is to demonstrate lower mean gradient by Echo 30 days after TAVI procedure with Allegra (Biosensors), versus patients treated by...
