Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation
Recruiting
Observational Study
Severe Aortic Valve Stenosis
Valvular Heart Disease
Aortic Valve Stenosis
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About This Trial
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 i…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
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.
Ex…
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