Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation
This study is designed to evaluate the success rate of transfemoral implantation of the Hydra THV biological aortic valve prosthesis in patients with severe symptomatic aortic stenosis. The device is used in accordance with its Instructions for Use as a CE-marked transcatheter heart valve system. The study will assess procedural success, device performance, and early clinical outcomes following implantation. Patients undergoing transcatheter aortic valve replacement (TAVR) via the transfemoral approach will be followed to evaluate safety and effectiveness outcomes, including short- and mid-term clinical follow-up.
⁃ Participants who meet ALL of the following conditions will be included:
• Age ≥ 18 years and;
• Severe aortic stenosis with indication for aortic valve replacement in which a Hydra THV device is implanted according to the instructions for use; and
• Signed informed consent.