Hydra Registry - Italy Experience
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hydra Transcatheter Aortic Valve System.
- Who it may be relevant to
- Registry conditions: Aortic Valve Stenosis. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Observational Study on the Efficacy and Safety of Transcatheter Implantation of Hydra Biological Aortic Prosthesis
Overview
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.
Detailed description
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.
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.
Primary outcome measures
- Cardiovascular mortality [Time frame: 30 days]
Secondary outcome measures (12)
- All-cause mortality [Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years]
- All stroke [Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years]
- Disabling stroke [Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years]
- Myocardial infarction [Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years]
- Life-threatening or disabling bleeding [Time frame: 30 days]
- Major vascular complications [Time frame: 30 days]
- Acute kidney injury (Stage 2 or 3) [Time frame: 30 days]
- New permanent pacemaker implantation (PPM) [Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years]
- Paravalvular Leak (PVL) [Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years]
- Effective Orifice Area (EOA) [Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years]
- Mean aortic valve gradient [Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years]
- New York Heart Association (NYHA) functional classification [Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Italy · 4 centers
- Fondazione Poliambulanza Istituto — Brescia
- Montevergine Clinic, Mercogliano, Italy — Mercogliano
- IRCCS Ospedale Galeazzi-Sant'Ambrogio — Milan
- Università degli studi di Padova — Padova
Identifiers
NCT: NCT05956652 · Hydra-IT, V1.0, 02/03/2022