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.

NCT Number	NCT07566624
Lead Sponsor	Fundación EPIC
Conditions	Severe Aortic Valve Stenosis, Valvular Heart Disease, Aortic Valve Stenosis
Enrollment	100 participants
Start Date	2026-07-07
Primary Completion	2029-01-01 (estimated)
Study Completion	2029-02-01 (estimated)
Updated on ClinicalTrials.gov	2026-08-05