Hydra Registry - Italy Experience

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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: Hydra Transcatheter Aortic Valve System

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Dr. Angelo Cioppa; Phone Number: +390825705131; Email: emodinamica@clinicamontevergine.it

Study Locations

• Italy
  • Brescia, Italy, 25124
    • Recruiting
    • Fondazione Poliambulanza Istituto
  • Mercogliano, Italy, 83013
    • Recruiting
    • Montevergine Clinic, Mercogliano, Italy
    • Contact: Dr. Angelo Cioppa
  • Milan, Italy, 20157
    • Not yet recruiting
    • IRCCS Ospedale Galeazzi-Sant'Ambrogio
  • Padova, Italy, 35122
    • Not yet recruiting
    • Universita Degli Studi Di Padova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient with severe aortic valve stenosis

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cardiovascular mortality	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major vascular complications		30 days
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
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

Collaborators and Investigators

• Sponsor: Sahajanand Medical Technologies Limited
• Collaborators: Clinica Di Montevergine
• Investigators: Principal Investigator: Dr. Angelo Cioppa, Montevergine Clinic, Mercogliano, Italy

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2029

Study Registration Dates

• First Submitted: July 14, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Actual): July 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Aortic Valve Stenosis; TAVI; Hydra
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: Hydra-IT, V1.0, 02/03/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No