Hydra Registry - Italy Experience

Recruiting

• Conditions: Aortic Valve Stenosis

• Registration Number: NCT05956652
• Lead Sponsor: Sahajanand Medical Technologies Limited

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.

Study Timeline

• Study Start: 2023-07-01
• Study First Submitted: 2023-07-14
• Study First Submitted QC: 2023-07-14
• Study First Posted: 2023-07-21
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2025-07-31
• Study Completion: 2029-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiovascular mortality	30 days

Secondary Outcome Measures

Name	Time	Method
Myocardial infarction	30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
New permanent pacemaker implantation (PPM)	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
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
Disabling stroke	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
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
Paravalvular Leak (PVL)	30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

Trial Locations

Locations (4)

Fondazione Poliambulanza Istituto; 🇮🇹 Brescia, Italy

Montevergine Clinic, Mercogliano, Italy; 🇮🇹 Mercogliano, Italy

IRCCS Ospedale Galeazzi-Sant'Ambrogio; 🇮🇹 Milano, Italy

Università degli studi di Padova; 🇮🇹 Padova, Italy