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Hydra Registry - Italy Experience | Clinical Trials | Clareo Health

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RECRUITINGNCT05956652

Hydra Registry - Italy Experience

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 ao...

Lead sponsor: Sahajanand Medical Technologies Limited•4 locations•View source on ClinicalTrials.gov

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Contacts

Dr. Angelo Cioppa

CONTACT

+390825705131 emodinamica@clinicamontevergine.it

Sponsors

Lead Sponsor

Sahajanand Medical Technologies Limited

Collaborators

Clinica Di Montevergine

Hydra-IT is a multicenter observational study conducted across different centres in Italy. The primary objective of the study is to evaluate the safety and efficacy of transcatheter aortic valve implantation and clinical outcome in patients treated with Hydra device. Secondary objective is to evaluate the long term (up to 5 years) effectiveness and the quality of treatment using Hydra device. Patients with severe stenosis symptomatic of the native aortic valve or bioprosthesis in a degenerated aortic position will be included in this study.

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•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

Exclusion Criteria

•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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: April 27, 2026Terms

Trial snapshot

StatusRECRUITING

Phase—

Enrollment500

Start dateJul 2023

Last updatedApr 27, 2026

Condition

Aortic Valve Stenosis

Locations shown

Fondazione Poliambulanza Istituto

Brescia

Montevergine Clinic, Mercogliano, Italy

Mercogliano

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 27, 2026Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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