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RECRUITING
NCT05956652

Hydra Registry - Italy Experience

Sponsor: Sahajanand Medical Technologies Limited

View on ClinicalTrials.gov

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

Interventions

DEVICE

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