Hydra Registry - Italy Experience

Sahajanand Medical Technologies

Status: Enrolling

Conditions: Aortic Valve Stenosis

Treatments: Device: Hydra Transcatheter Aortic Valve System

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05956652

Hydra-IT, V1.0, 02/03/2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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