ACTIVE NOT RECRUITING
NCT05261204
Transcatheter Aortic Valve Implantation Versus Standard Surgical Aortic Valve Replacement
The mechanical intervention is treating aortic valve stenosis (AVS) which may be performed using the standard open surgical approach for aortic valve replacement (AVR) or transcatheter aortic valve implantation (TAVI). The key question of this study is to establish the difference in all-cause and cause-specific (cardiac vs noncardiac) mortality, all hospitalizations for heart failure within 24 months of follow-up, left ventricular reverse remodeling after adjustment for death, as assessed by means of the left ventricular end-diastolic volume (LVEDV), in patients who received the TAVI vs the standard surgical procedure for AVS. Any potential failure of the devices in question will be thoroughly investigated by means of CT scanning and biomechanical computational modelling, utilising finite element analysis (FEA).
Gender: All
Ages: 18 Years - 90 Years
Prosthesis Survival
Prosthesis; Cardiac, Heart, Functional Disturbance as Result