Hydra Registry - Italy Experience

Recruiting now

Conditions studied: Aortic Valve Stenosis

In brief

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.

Key facts

Study ID

NCT05956652

Run by

Sahajanand Medical Technologies Limited

People needed

500

Starts

2023-07-01

Expected to finish

2029-07-31

Last updated by the study team

2026-04-27

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with severe symptomatic native aortic valve stenosis and candidates for the TAVI procedure based on the evaluation of the Heart Team
• Ability to understand and provide informed consent for inclusion in the study

You may not qualify if…

• Contraindication to TAVI: e.g. evidence of intracardiac mass, thrombus or vegetation, endocarditis.
• Refusal by the patient to participate in the study
• High probability of non-adherence to required follow-ups

Where it is running

• Fondazione Poliambulanza Istituto — Brescia, Italy (enrolling)
• Montevergine Clinic, Mercogliano, Italy — Mercogliano, Italy (enrolling)
• IRCCS Ospedale Galeazzi-Sant'Ambrogio — Milan, Italy
• Università degli studi di Padova — Padova, Italy

Full record on ClinicalTrials.gov

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