Hydra Registry - Italy Experience

Sahajanand Medical Technologies Limited500 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Aortic Valve Stenosis

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (4)

Fondazione Poliambulanza Istituto

Brescia, Italy

RECRUITING

Montevergine Clinic, Mercogliano, Italy

Mercogliano, Italy

RECRUITING

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, Italy

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Cardiovascular mortality

Time frame: 30 days

Secondary Outcomes

All-cause mortality

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

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

All stroke

Disabling and non-disabling 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)

Central Contacts

Dr. Angelo Cioppa

CONTACT

+390825705131 emodinamica@clinicamontevergine.it

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.