Aortic Valve StenosisNCT05956652
Hydra Registry - Italy Experience
An observational study of Aortic Valve Stenosis, run by Sahajanand Medical Technologies Limited at 4 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Hydra Transcatheter Aortic Valve System
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 4 sitesItaly
- Study dates
- 1 Jul 2023to 31 Jul 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with severe aortic valve stenosis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
Fondazione Poliambulanza Istituto
Brescia, 25124
Montevergine Clinic, Mercogliano, Italy
Mercogliano, 83013
IRCCS Ospedale Galeazzi-Sant'Ambrogio
Milan, 20157
Università degli studi di Padova
Padova, 35122
About this study
Official title: Observational Study on the Efficacy and Safety of Transcatheter Implantation of Hydra Biological Aortic Prosthesis
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.
Read the 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.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Hydra Transcatheter Aortic Valve System
- Keywords
- Aortic Valve Stenosis, TAVI, Hydra
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydra Transcatheter Aortic Valve SystemDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular mortality
Measured: 30 days
Secondary outcomes (12)
All-cause mortality
Cardiovascular mortality, valve-related mortality, and non-cardiovascular mortality
Measured: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
All stroke
Disabling and non-disabling stroke
Measured: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Disabling stroke
Measured: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Myocardial infarction
Measured: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Life-threatening or disabling bleeding
Measured: 30 days
Major vascular complications
Measured: 30 days
Acute kidney injury (Stage 2 or 3)
Measured: 30 days
New permanent pacemaker implantation (PPM)
Measured: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Paravalvular Leak (PVL)
Measured: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Effective Orifice Area (EOA)
Measured: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Mean aortic valve gradient
Measured: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
New York Heart Association (NYHA) functional classification
Measured: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start1 Jul 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2029 (estimated)
Why it stopped: Withdrawn (No Participants Enrolled)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Sahajanand Medical Technologies Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinica Di Montevergine
- Responsible party
- Sponsor
- Investigators
- Dr. Angelo Cioppa, Principal investigator, Montevergine Clinic, Mercogliano, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956652
- Sponsor's protocol ID
- Hydra-IT, V1.0, 02/03/2022
- Status last verified
- Aug 2026
- First submitted
- 14 Jul 2023
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No