Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation
Fundación EPIC
100 participants
Jul 7, 2026
OBSERVATIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Patients in whom the Hydra THV device is implanted to treat patients with degenerated aortic bioprostheses.
Locations(1)
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NCT07566624