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Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation
Sponsor: Fundación EPIC
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2026-07-07
Completion Date
2029-02-01
Last Updated
2026-08-05
Healthy Volunteers
No
Interventions
Hydra THV
Patients in whom the Hydra THV device is implanted to treat patients with degenerated aortic bioprostheses.
Locations (2)
Hospital Universitario La Paz
Fuencarral-El Pardo, Spain
Hospital Clínico Universitario de Santiago
Santiago de Compostela, Spain