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Hydra Registry - Italy Experience
Sponsor: Sahajanand Medical Technologies Limited
Summary
Hydra-IT is a multicenter observational study aim to collect clinical, procedural and follow-up data and evaluate the short, medium and long term results of Hydra TAVI System in patient with severe aortic stenosis.
Official title: Observational Study on the Efficacy and Safety of Transcatheter Implantation of Hydra Biological Aortic Prosthesis
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
OBSERVATIONAL
Enrollment
500
Start Date
2023-07-01
Completion Date
2029-07-31
Last Updated
2025-05-16
Healthy Volunteers
No
Conditions
Interventions
Hydra Transcatheter Aortic Valve System
The Hydra device is self-expanding transcatheter aortic valve consists of a self-expanding nitinol frame and three bovine pericardial leaflets in supra-annular position.
Locations (4)
Fondazione Poliambulanza Istituto
Brescia, Italy
Montevergine Clinic, Mercogliano, Italy
Mercogliano, Italy
IRCCS Ospedale Galeazzi-Sant'Ambrogio
Milan, Italy
Università degli studi di Padova
Padova, Italy