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Hydra Registry - Italy Experience

NCT05956652 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2026-04-27

No results posted yet for this study

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.

Conditions

  • Aortic Valve Stenosis

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.

Sponsors & Collaborators

  • Clinica Di Montevergine

    collaborator OTHER

  • Sahajanand Medical Technologies Limited

    lead INDUSTRY

Principal Investigators

  • Dr. Angelo Cioppa · Montevergine Clinic, Mercogliano, Italy

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2027-07-31
Completion
2029-07-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05956652 on ClinicalTrials.gov