Hydra Registry - Italy Experience

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Device: Hydra Transcatheter Aortic Valve System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular mortality |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | Cardiovascular mortality, valve-related mortality, and non-cardiovascular mortality | 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years | 
| All stroke | Disabling and non-disabling stroke | 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 | 
| Myocardial infarction |  | 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic Valve Stenosis, TAVI, Hydra