EasyCrossTM Device-Self-centering Catheter

"At T0 the patient will undergo the TAVR procedure including the investigational procedure with the VIVHEART EasyCross™ catheter.~The interventional cardiologist will introduce the VIVHEART EasyCross™ catheter through the femoral artery with a percutaneous access according to the clinical practice through a vascular introducer on an already positioned guidewire. An operator in the procedure room will start a chronometer at this point to measure the investigational device crossing procedure duration.~The VIVHEART EasyCross™ catheter will be progressed into the aorta and up to the aortic valve.~At that time the external part of the VIVHEART EasyCross™ catheter will be opened to allow the self-centering of the catheter on the aortic valve. The guidewire will be introduced and once having crossed the valve the VIVHEART EasyCross™ catheter will be retracted by the physician and removed from the patient's body."