Actively Recruiting

Age: 18Years - 99Years
All Genders
NCT05956652

Hydra Registry - Italy Experience

Led by Sahajanand Medical Technologies Limited · Updated on 2026-04-27

500

Participants Needed

4

Research Sites

317 weeks

Total Duration

On this page

Sponsors

S

Sahajanand Medical Technologies Limited

Lead Sponsor

C

Clinica Di Montevergine

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Hydra Registry - Italy Experience

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with severe symptomatic native aortic valve stenosis who are candidates for TAVI procedure as evaluated by the Heart Team
  • Ability to understand and provide informed consent for study participation
Not Eligible

You will not qualify if you...

  • Contraindications to TAVI such as intracardiac mass, thrombus, vegetation, or endocarditis
  • Patient refusal to participate in the study
  • High likelihood of not adhering to required follow-up visits

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Fondazione Poliambulanza Istituto

Brescia, Italy, 25124

Actively Recruiting

2

Montevergine Clinic, Mercogliano, Italy

Mercogliano, Italy, 83013

Actively Recruiting

3

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, Italy, 20157

Not Yet Recruiting

4

Università degli studi di Padova

Padova, Italy, 35122

Not Yet Recruiting

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Research Team

D

Dr. Angelo Cioppa

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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