RecruitingNCT07566624

Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation


Sponsor

Fundación EPIC

Enrollment

100 participants

Start Date

Jul 7, 2026

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Hydra THV for people with aortic valve stenosis, severe aortic valve stenosis, and other related conditions. The study is currently recruiting participants at 1 location.

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

DEVICEHydra THV

Patients in whom the Hydra THV device is implanted to treat patients with degenerated aortic bioprostheses.


Locations(1)

Hospital Universitario La Paz

Fuencarral-El Pardo, Spain

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NCT07566624


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