Aortic Valve Stenosis
Conditions
Keywords
Aortic Valve Stenosis, TAVI, Hydra
Brief 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.
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
DEVICEHydra 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
Sahajanand Medical Technologies Limited
Clinica Di Montevergine
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiovascular mortality | 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Life-threatening or disabling bleeding | 30 days | — |
| Major vascular complications | 30 days | — |
| Acute kidney injury (Stage 2 or 3) | 30 days | — |
| New permanent pacemaker implantation (PPM) | 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years | — |
| Paravalvular Leak (PVL) | 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years | — |
| Effective Orifice Area (EOA) | 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years | — |
| Mean aortic valve gradient | 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years | — |
| New York Heart Association (NYHA) functional classification | 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years | — |
| All-cause mortality | 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years | Cardiovascular mortality, valve-related mortality, and non-cardiovascular mortality |
| All stroke | 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years | Disabling and non-disabling stroke |
| Myocardial infarction | 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years | — |
| Disabling stroke | 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years | — |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORDr. Angelo Cioppa
Montevergine Clinic, Mercogliano, Italy
Outcome results
None listed