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NCT Number: NCT05956652

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 aortic stenosis.

Why the study stopped: Withdrawn (No Participants Enrolled)
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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Poliambulanza Istituto, Brescia, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydra Transcatheter Aortic Valve System

Device

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.

Primary outcomes

  1. Cardiovascular mortality

    Time frame: 30 days

Secondary outcomes

  1. All-cause mortality

    Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

    Cardiovascular mortality, valve-related mortality, and non-cardiovascular mortality

  2. All stroke

    Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

    Disabling and non-disabling stroke

  3. Disabling stroke

    Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

  4. Myocardial infarction

    Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

  5. Life-threatening or disabling bleeding

    Time frame: 30 days

  6. Major vascular complications

    Time frame: 30 days

  7. Acute kidney injury (Stage 2 or 3)

    Time frame: 30 days

  8. New permanent pacemaker implantation (PPM)

    Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

  9. Paravalvular Leak (PVL)

    Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

  10. Effective Orifice Area (EOA)

    Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

  11. Mean aortic valve gradient

    Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

  12. New York Heart Association (NYHA) functional classification

    Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

Sponsors and collaborators

Lead sponsor

Sahajanand Medical Technologies Limited

Industry

Collaborators

  • Clinica Di Montevergine

Registry information

Official study title

Observational Study on the Efficacy and Safety of Transcatheter Implantation of Hydra Biological Aortic Prosthesis

Important dates

Study start
2023
Primary completion
2027
Study completion
2029
First posted
Jul 21, 2023
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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