Transcatheter Aortic Valve Replacement (TAVR) Clinical Trial
Official title:
VIVHEART Transcatheter Aortic Valve Replacement (TAVR) Self-centering Catheter First-in-human Feasibility Trial (VIV-FIH)
VIVHEART EasyCross™ is a self-centering device for inserting a guidewire through a heart valve. It consists in a temporary catheter inserted into an artery with a terminal part able to expand a distal structure with 6 arms ("basket") to allow distancing of the catheter from the vessels walls and thus facilitating the passage of the guide wire through the aortic valve. The device is expected to reduce the attempts and the time needed to cross the valve and improves the safety of TAVR procedure
VIVHEART EasyCross™ is a self-centering device for inserting a guidewire through a heart valve. It consists in a temporary catheter inserted into an artery with a terminal part able to expand a distal structure with 6 arms ("basket") to allow distancing of the catheter from the vessels walls and thus facilitating the passage of the guide wire through the aortic valve. The device is expected to reduce the attempts and the time needed to cross the valve and improves the safety of TAVR procedure. EasyCross™ device is a catheter is intended to allow a rapid and safe centering of a heart valve in order to direct and introduce a guidewire through it. The intended purpose is the use of the device during percutaneous TAVR procedures, including TAVR of a native valve, recrossing and balloon post-dilation of a prosthetic aortic valve, or a valve-in-valve aortic valve replacement within the scope of the CE mark. The VIVHEART EasyCross™ device is intended for patients candidate to TAVR of a native valve, recrossing and balloon post-dilation of a prosthetic aortic valve, or a valve-in-valve aortic valve replacement. The suitability of the patient is to be verified case by case by the specialized physician, by means of proper physical examination and instrumental evaluation, according to clinical practice. ;
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